Understanding

IBD Medications
and Side Effects

a
What’s Inside
About Crohn’s Disease and
Ulcerative Colitis........................................................ 2
Over-the-Counter (OTC) Medications .............. 5
Prescription Medications ........................................ 6
Off-Label.......................................................................... 9
Complementary and alternative
therapies ......................................................................... 9
Pediatric IBD Patients............................................ 10

Making the Most of Your Treatment.................12

Tips to Help You Manage Your
Medications.................................................................. 13
What to Ask Your Healthcare Provider
About Your Medications......................................... 14
Remember to Tell the Doctor.............................. 15
Pregnancy and Male Fertility................................16

Participation in Clinical Trials............................. 18

Improving Quality of Life..................................... 20

Tools and Resources................................................21

Aminosalicylates (5-ASA)..................................... 22
Antibiotics.................................................................... 24
Biologics........................................................................ 25
If you or someone you know has just been
Corticosteroids.......................................................... 34
diagnosed with Crohn’s disease or ulcerative
Immunomodulators................................................. 36
colitis, you may feel a bit overwhelmed by the
Janus Kinase Inhibitors (JAK Inhibitors)........ 39
news. In fact, you may not have even heard of
Glossary...................................................................... 40 these illnesses before. But now that you have,
or even if you have been living with inflam-
matory bowel diseases for quite a while, you
The Crohn’s & Colitis Foundation provides information for
educational purposes only, which is current as of the print will want to learn as much as possible about
date. We encourage you to review this educational mate- them—including which medications can help
rial with your health care professional as this information control the diseases. That is the purpose of
should not replace the recommendations and advice of
this brochure.
your doctor. The Foundation does not provide medical or
other health care opinions or services. The inclusion of
another organization’s resources or referral to another
organization does not represent an endorsement of a
particular individual, group, company or product.

1
About Crohn’s Disease of both ulcerative colitis and Crohn’s disease, a
condition called indeterminate colitis.
and Ulcerative Colitis
On average, people are more frequently diag-
Crohn’s disease and ulcerative colitis belong nosed with IBD between the ages of 15 and
to a group of conditions known as inflamma- 35, although the disease can occur at any age.
tory bowel diseases, or IBD. These disorders The number of IBD patients has significantly
affect the gastrointestinal (GI) tract, the area increased over the last 50 years. While multi-
of the body where digestion takes place. As ple contributing factors have been found, the
the name implies, these diseases cause inflam- exact cause of these diseases is unknown and
mation of the intestine. When a part of the currently there are no cures for Crohn’s disease
body is inflamed, it becomes swollen. Sores, or and ulcerative colitis. This makes the role of
ulcers, may also form within the walls of the the Crohn’s & Colitis Foundation in supporting
intestine. The ongoing inflammation leads to research so critical. The Foundation has pio-
symptoms that may already be familiar to you: neered the research of these difficult to under-
abdominal pain, cramping, diarrhea, rectal stand digestive diseases for over a half-century.
bleeding, and fatigue. For some people, their Some of our major projects include our
symptoms are not just restricted to the GI tract. Genetics Initiative (research studies focused
They may experience signs of IBD in other on the genes associated with IBD), Microbiome
parts of the body, such as the eyes, joints, skin, Initiative (studying bacterial, viral, and fungal
bones, kidneys, and liver. These are referred species that reside in the gut and can affect the
to as extraintestinal complications of IBD, course of disease), and Environmental Triggers
because they occur outside of the intestine. Initiative (research into the impact of lifestyle,
psychological stress, nutrition, and other exter-
Although Crohn’s disease and ulcerative colitis nal factors).
share a lot of symptoms, they do have some
marked differences. While inflammation re-
lated to Crohn’s disease may involve any part THE GASTROINTESTINAL
of the GI tract from the mouth to the anus (GI) TRACT
(including the esophagus, stomach, small in- 1 Oral Cavity (mouth)
testine, and large intestine), ulcerative colitis 1
2 Esophagus (throat)
is limited to just the large intestine (including
the colon and rectum). Another distinguishing 2 3 Liver

feature of ulcerative colitis is that it starts in 4 Stomach

the rectum and extends from there in a contin- 5 Large Intestine/Colon
uous area of inflammation. In contrast, Crohn’s 3
4
6 Small Intestine
disease may appear in “patches,” affecting
some areas of the GI tract while leaving other 7 Rectum
5
sections in between completely untouched. 6 8 Anus
These are known as “skip” areas. These dif-
ferences are important for deciding whether 7
inflammation of the intestinal tract is from 8
Crohn’s disease or ulcerative colitis. In 10 per-
cent of cases there are overlapping features

2 3
Treatment • Medications can be given in oral form (by
mouth), intravenously (through a vein), or
subcutaneously (by injection under the skin).
To date, there is no known cause of or cures
Topical therapies are administered rectally, as
for IBD, but fortunately there are many effec-
suppositories, enemas, creams, and ointments.
tive treatments to help control the symptoms
of these diseases. The two main goals of treat- • A person’s therapeutic needs may change
ments for IBD are: over time. What works at one point during
the disease may not be effective during
• Achieving remission (defined as the absence
another stage. It is important for the patient
of symptoms)
and doctor to thoroughly discuss which
• Maintaining remission (defined as preventing course of therapy is best, balancing the bene-
flare-ups of disease) fits and risks of each treatment option.
These goals may be achieved with a combi- • With the right treatment, patients may pos-
nation of over-the-counter and prescription sibly achieve a life with minimal symptoms.
medications or surgery, depending on each Patients should have an open dialogue with
individual case. For more on surgery, visit their doctor and inform them if they are still
www.crohnscolitisfoundation.org. experiencing IBD symptoms or a change in
symptoms while on treatment. During these
When considering medication options, it is im-
discussions, patients should feel comfortable
portant to work together with your provider to
asking their doctor about other available
make the best choice of treatment that aligns
treatment options.
with your personal goals and preferences.
Please keep in mind the following:
Over-the-Counter (OTC) Medications
• Symptoms of these long-term diseases may Prescription medications reduce intestinal
range from mild to severe and may include, inflammation and form the core of IBD treat-
but are not limited to, diarrhea, abdominal ments. Even so, these important prescription
cramping, nausea, pain, rectal bleeding, medications may not eliminate all of your
and fever. symptoms. Naturally, you may want to take
• People will go through periods in which the over-the-counter medications in an effort to
illness is active and is flaring. These episodes feel better. Before doing so, speak with your
are usually followed by times of remission. doctor, as sometimes these symptoms may
Remission occurs when symptoms either dis- indicate a worsening of the inflammation that
appear completely or lessen considerably and may require a change in your prescription.
good health returns. These remission periods
can last months or even years. Other times these symptoms do not reflect a
worsening of the condition and can be treated
• Because each person with IBD is different, with over-the-counter medications. For exam-
the treatment used to control his or her ill- ple, your doctor may recommend loperamide
ness is unique. Doctors will customize treat- (Imodium®) to relieve diarrhea, or anti-gas
ment to the individual’s needs based on the products for bloating. To reduce joint pain or
type and severity of symptoms. Medications fever, your doctor may recommend acetamino-
may be given in different dosages, formula- phen (Tylenol®) or non-steroidal anti-inflamma-
tions, and for different lengths of time. tory drugs (NSAID)—such as aspirin, ibuprofen

4 5
(Motrin,® Advil®), or naproxen (Aleve®). NSAIDs tally, or intravenously. They are effective
will work to alleviate joint symptoms but can for short-term control of disease activity
irritate the GI tract, thus promoting inflamma- (flares); however, they are not recommend-
tion. NSAIDs should be used with great care. ed for long-term or maintenance use be-
Make sure that you follow instructions with cause of their side effects such as swelling,
all OTC products, but again, speak with your weight gain, hair growth, and acne. Long-
healthcare professional before you take any of term steroid use can also lead to weakened
these medications. bones (osteoporosis). If you cannot come off
steroids without a relapse of symptoms, your
Prescription Medications doctor may add some other medications to
Some medications used to treat Crohn’s dis- help manage your disease. It is important not
ease and ulcerative colitis have been around to suddenly stop taking this medication. If you
for years. Others are more recent break- stop suddenly, you may experience symptoms
throughs. The most commonly prescribed such as severe fatigue, weakness, body aches,
medications fall into the following categories: joint pain, nausea, or a decrease in appetite.
• Aminosalicylates: These include medications • Immunomodulators: These include azathio-
that contain 5-aminosalicylic acid (5-ASA) prine, 6-mercaptopurine (6-MP), methotrex-
such as sulfasalazine, balsalazide, mesal- ate, cyclosporine, and tacrolimus. This class
amine, and olsalazine. These medications of medications modifies the body’s immune
work by inhibiting certain pathways that system so that it cannot cause ongoing
produce substances that cause inflamma- inflammation. Usually given orally (metho-
tion. They can work at the level of the lining trexate can also be injectable), immunomod-
of the GI tract to decrease inflammation. ulators are typically used in people for whom
They are thought to be effective in treating aminosalicylates and corticosteroids haven’t
mild-to-moderate episodes of IBD, and are been effective, or have been only partially
useful as a maintenance treatment in pre- effective. They may be useful in reducing or
venting relapses of the disease. They work eliminating reliance on corticosteroids. They
best in the colon and are not particularly also may be effective in maintaining remission
effective if the disease is limited to the small in people who haven’t responded to other
intestine. These are often given orally in the medications given for this purpose. Immuno-
form of delayed release tablets to target the modulators may take up to three months to
colon, or rectally as enemas or suppositories. begin working. All patients on immunomod-
ulators need to be monitored closely for side
• Corticosteroids: These medications, which
effects, such as bone marrow problems as
include prednisone, prednisolone, meth-
well as irritation of the liver or pancreas.
ylprednisolone, and budesonide, affect
the body’s ability to begin and maintain an
inflammatory process. In addition, they work
to keep the immune system in check. Pred-
nisone and prednisolone are used for people
with moderate-to-severe Crohn’s disease and
ulcerative colitis. Budesonide is used for
people with mild-to-moderate ileal Crohn’s
disease, and right-sided colon Crohn’s dis-
ease. They can be administered orally, rec-

6 7
• Biologic therapies: These therapies are bio- • Janus kinase inhibitors (JAK Inhibitors):
engineered drugs that target very specif- These medications, currently available as
ic molecules involved in the inflammatory tablets, are broken down in the gastrointes-
process. These are not drugs but antibodies tinal tract after ingestion and are directly ab-
(types of proteins) that target the action of sorbed into the bloodstream via the intestinal
other proteins that cause inflammation. wall. Due to the small size of these chemical-
ly active substances, they can be transported
These medications are indicated for people
through the bloodstream to nearly any site
with moderately to severely active disease.
in the body, including the immune system.
They also are effective for reducing fistulas.
Unlike some of the other tablet-based agents
Fistulas, which may occur with Crohn’s dis-
like thiopurines and methotrexate, these
ease, are small tunnels connecting the intes-
agents work more quickly and can induce and
tine to another area of the body to which it is
maintain remission. Tofacitinib is the first JAK
not usually connected.
inhibitor approved to treat ulcerative colitis.
Biologics may be an effective strategy for
reducing steroid use, as well as for maintain- Off-Label
ing remission. While on biologics, you should Sometimes doctors will prescribe medications
not receive any live vaccines. Be sure to speak that the Food and Drug Administration (FDA)
with your healthcare provider about appro- has not specifically approved for the treatment
priate vaccinations before starting these of Crohn’s or ulcerative colitis. Nonetheless,
medications. these medications have been shown to be very
Biosimilars are similar, near identical copies effective in reducing symptoms. Prescribing
of other already approved biologic therapies, medications for other than FDA-approved con-
known as the reference product or originator ditions is known as “off-label” use. Your health-
biologic. They are drugs that act just like a care provider may have to obtain prior approval
reference product, having the same effective- from insurance companies before prescribing a
ness and safety in the patient population that medication for off-label use. Patients should be
it treats. Examples of this class of therapy in- aware that they or their doctor might need to
clude infliximab biosimiliars: infliximab-abda, make a special appeal in order for their insur-
infliximab-dyyb and infliximab-qbtx as well ance company to pay for an off-label medication.
as adalimumab biosimilars: adalimumab-atto
and adalimumab-adbm. Complementary and alternative
therapies
• Antibiotics: Antibiotics may be used when
Some people living with Crohn’s disease and
infections—such as an abscess (pocket of
ulcerative colitis look toward complementary
pus)—occur. They treat Crohn’s disease, peri-
and alternative medi­cines (CAM) to use togeth-
anal Crohn’s disease, and ulcerative colitis.
er with conventional therapies to help ease their
They are also used to treat pouchitis, which
symptoms. CAM therapies may work in a variety
is an inflammation of the ileal pouch (also
of ways. They may help to control symptoms
known as a j-pouch, a surgically constructed
and ease pain, enhance feelings of well-being
internal pouch for those who have had their
and quality of life, and possibly boost the im-
large intestine removed), and for prevention
mune system. Speak with your doctor about the
of recurrent Crohn’s disease after surgery.
best thera­pies for your situation.

8 9
For further information about complemen- to teach your child how to swallow pills at
tary and alternative therapies, view our www.crohnscolitisfoundation.org.
Complemen­tary and Alternative Medicine fact
• Corticosteroids: When a child has not
sheet at www.crohnscolitisfoundation.org/
responded to treatment with a 5-ASA, or if
brochures.
their disease is more severe at onset, oral
corticosteroids may be prescribed. For severe
Pediatric IBD Patients cases, intravenous corticosteroids may be
used—necessitating a hospital stay. Once re-
Customizing treatment for the individual with mission is achieved, corticosteroid dosage is
IBD is critical, including when that patient is a tapered gradually. When patients are tapered
child or teenager. off of corticosteroids, a strict schedule should
be followed in order to minimize side effects
Most pediatric treatment choices were devel- that can occur if patients are weaned off too
oped after initial research on adults. As a result, quickly. Long-term steroid use in children
drug dosages for a child must be carefully tai- can also lead to growth problems and weak-
lored to suit their age, size, and weight—in ad- ened bones (osteoporosis). To minimize the
dition to existing symptoms, location of inflam- chance of osteoporosis, adequate calcium
mation, and previous response to treatment. and vitamin D intake is essential.
• Immunomodulators: While immunomod-
The same medications that are used to treat ulators can be prescribed for children with
adults with IBD are also used for children. Still, Crohn’s disease and ulcerative colitis the
there are some special considerations in treat- approach to their use as a treatment can vary.
ment because children and teenagers are going Immunomodulators may often be prescribed
through a period of physical and emotional as a combination therapy with biologics. All
growth and development. Here are some of patients on immunomodulators need to be
the recommendations for the various medica- monitored closely for side effects, such as
tion categories: bone marrow problems as well as irritation
• Aminosalicylates: These compounds that of the liver or pancreas. Live vaccines are
contain 5-aminosalicylic acid (5-ASA) are gen- not recommended for IBD patients taking
erally the first step in therapy for children with immunomodulators.
mild-to-moderate ulcerative colitis or mild • Biologic therapies: Biologic therapies are
Crohn’s disease of the colon. Mesalamine, commonly used in the treatment of pediat-
balsalazide, and olsalazine have fewer side ric IBD. Some of these therapies have been
effects than sulfasalazine. Drugs can be given specifically approved by the FDA for use in
either orally or rectally. The number of pills children ages 6-17. Examples include inflix-
may be as many as 10 or more per day, which imab, and adalimumab, which are approved
your doctor will advise how to handle with for children with moderate-to-severe Crohn’s
respect to your child’s school schedule. Also, disease and ulcerative colitis. Other biologic
some children have trouble swallowing pills. In therapies are being tested in children and are
cases where swallowing capsules is a concern, currently used in specific situations.
your child’s doctor may advise that specific
capsules be opened and the contents mixed Live vaccines are not recommended for IBD
with food. You can download a pill-swallowing patients taking biologic medications. It is
handout that will provide information on how

10 11
 important to talk to your health care provider Even when there are no side effects, taking
about which vaccines are safe for your child medication as prescribed by your doctor can
to receive. seem like a nuisance, but it is an important step
in helping manage your disease. Remember,
• Antibiotics: Metronidazole is used in children
taking medication to maintain remission can
and teenagers with perianal Crohn’s disease.
significantly reduce the risk of flares in both
It may also be used as an alternative treat-
Crohn’s disease and ulcerative colitis.
ment to 5-ASA or steroids for Crohn’s colitis.
Another antibiotic option is ciprofloxacin, Tips to Help You Manage Your
which has been shown to be effective in Medications
adults with Crohn’s colitis and inflammatory
changes around the anus, including fistulas • Taking medication correctly means more
and abscesses in Crohn’s disease. The use than just taking the right amount at the right
of ciprofloxacin and other drugs in the same time. Talk to your doctor or pharmacist and
class, called fluorquinolones, has been learn as much as possible about the medica-
associated with an increased risk of tendon- tions you take and how they may affect you.
itis and joint discomfort or pain. Their use in For example, sometimes medications should
children has been controversial in the past, be taken with food and other times on an
although studies have not demonstrated any empty stomach.
increased risk of complications in children • Some medications require close monitoring
compared to adults. for side effects. This may require blood
work and follow-up visits as requested by
your doctor.
Making the Most of Your • If possible, use the same pharmacy every time
Treatment you get your prescription filled. Pharmacies
can help you keep track of what you are taking.
Crohn’s disease and ulcerative colitis are long-
• Don’t take any medications that have expired.
term, chronic diseases. This means that people
with these conditions may need to take medi- • Don’t take anyone else’s medications or share
cation indefinitely. While not every person with yours with others.
IBD will be on medication all of the time, most
• Tell your doctor or pharmacist about all
people will require therapy most of the time to
medicines, supplements, or other things you
get well and stay well.
may be taking for your health, including OTC
For many individuals this may seem like a major medications, vitamins, and herbs.
concern, especially when some of those medi- • Use the medication log at the end of this
cations produce unwanted side effects. Side ef- brochure or an online tracker tool.
fects can vary and your doctor will explain which
• Immunomodulators and biologics can in-
side effects are serious and require immediate
crease the risk of upper respiratory and lung
attention, and which side effects are more mild
infections. Therefore it is recommended that
and common. If you are experiencing unpleasant
you be up-to-date on certain vaccinations.
side effects or interactions with other drugs,
Be aware that live virus vaccines might be
don’t stop taking your prescribed medication.
contraindicated in these situations.
Speak with your doctor and ask about possible
adjustments that might reduce those effects.

12 13
 • How long does it take for this medication
to start working?
• Can I take vitamins, minerals, herbs, or other
supplements while using the medication?
• Can I take OTC medications for joint pain,
diarrhea, or abdominal pain?
• Can I get vaccines while I am on my IBD
medication?
• What kind of side effects might I experience?
Which are cause for alarm, and what should I
do if these occur?
• What kind of interactions does this IBD
medication have with other medications I
may be taking for other conditions?
• What should I do if I miss a dose?
• What should I do if I have a negative reaction
If you are having trouble affording your medi- immediately after taking my medication?
cations, do not stop taking your medications.
• Is it safe to drink alcoholic beverages while
Alert your healthcare provider who may be able
on this medication?
to help you find a solution. It is important that
you take medications as prescribed, as some
Remember to Tell the Doctor
cannot be safely stopped abruptly. If the cost
of treatment presents a problem for you, or if Before starting new medications, it is important
you have an insurance change, there may be for you to tell your doctor and other healthcare
a number of patient assistance programs that providers (including dentists or emergency
can help. Visit www.crohnscolitisfoundation. room staff) about other medications you may
org/managingcosts. be taking. Tell them whether you:
• Have taken this drug before (even if there
What to Ask Your Healthcare Provider was no unusual reaction).
About Your Medications
• Have had an unusual or allergic reaction to
It is only natural that you will have some
this drug, or other medications.
concerns about the treatment that you will be
receiving for IBD. What should you ask your • Have or have had any other medical conditions.
doctor? What do you need to know about
• Take any other medication or drugs (pre-
your treatment? The following are some of the
scription or OTC), how long you have been
questions you may want to ask:
taking them, your dose, and any side effects
• Why is this medication necessary? you may have.
• How long will I need to take this medication? • Take any vitamins, minerals, herbs, or other
supplements.
• How does this medication work?

14 15
Pregnancy and Male • Corticosteroids. Prednisone and other
corticosteroids are low risk during pregnancy.
Fertility Corticosteroids are not recommended for
planned maintenance therapy in pregnant
With careful supervision of both a gastroenter- women, but talk to your doctor about use
ologist and an obstetrician, most women with during flares in pregnancy. If a woman be-
IBD can have a healthy pregnancy and a healthy comes pregnant while on steroids, the doctor
baby. If you are considering becoming preg- usually tries to minimize the dose. Nursing
nant, it is recommended to try to have your IBD infants of women on moderate-to-high dos-
in remission before you do so. ages of prednisone should be monitored by a
pediatrician.
Recent studies have shown that women do • Immunomodulators. Dosing of immunomod-
better during pregnancy if their disease is not ulators should be monitored during preg-
active at the time of conception. Most experts nancy. Although many immunomodulators
agree that the major threat to pregnancy may appear as low risk, there is limited data
seems to come from the active disease itself, in pregnancy. Both men and women should
rather than the medication being used to treat avoid methotrexate as it is known to cause
the disease. Having active disease during preg- birth defects.
nancy can increase the risk of having a baby
born prematurely or with a low birth weight. • Biologics. Most biologics, such as infliximab
(Remicade®), adalimumab (Humira®), and cer-
If you are pregnant and have IBD symptoms, tolizumab (Cimzia®), are considered low risk.
your doctor will advise you as to which of the They also do not appear in breast milk. How-
medications mentioned previously are safe to ever, both adalimumab and infliximab cross
take. In most cases, medication schedules are the placenta in high levels late in pregnancy,
maintained during pregnancy. However, there so your doctor may want to give the last dose
are some considerations and exceptions. It is in the middle of your third trimester.
also important to note that if a woman’s condi-
tion changes, drugs or dosages may be altered.
Here are some of the recommendations for the
various medica­tion categories:
• Aminosalicylates. Sulfasalazine (Azulfidine®)
and other 5-ASA compounds such as mesala-
mine (Asacol® HD, Pentasa,® Rowasa,® Cana-
sa,® Lialda®), balsalazide (Colazal®), and olsal-
azine (Dipentum®) do not appear to increase
complications or harm the fetus. Sulfasal-
azine may cause nausea and heartburn. As
sulfasalazine lowers folic acid levels, women
should be on at least 2 mg of folic acid daily.
Women can breastfeed while taking a 5-ASA
compound.

16 17
• Antibiotics. Antibiotics are not recommend- (the study of the body’s immune defense sys-
ed for planned maintenance therapy in IBD tem), microbiology (the study of microscopic
during pregnancy. organisms with the power to cause disease),
and genetics (the study of how various tenden-
• JAK Inhibitors. There is currently limited data
cies and traits—including diseases—are passed
in pregnancy. It is advised to consider other
from one generation to another).
options, particularly in the first trimester.
With new information being gathered all the
Because pregnancy is such a personal matter
time, there is good reason to be hopeful about
and there are so many factors that go into how
future treatment for IBD. While we all wish
a pregnancy may turn out, the choice of what
for better treatments today, it’s important
medicines to take before and during pregnancy
to understand that it takes a long time for a
should be discussed with the healthcare provid-
promising development in the laboratory to
er treating your disease, as well as your obstetri-
become a drug ready for consumer use. In fact,
cian and your maternal fetal medicine specialist.
the process of getting a drug to market, from
first testing to final approval by the Food and
While most of the recommendations regarding
Drug Administration (FDA), may take as long as
medication use and pregnancy focus on wom-
10 years.
en, there are some for men as well. For three
months before conception, men should avoid
Before a new drug or a new type of treatment
taking methotrexate. Also, because the med-
is approved, it must go through a series of
ication sulfasalazine decreases sperm count
clinical trials. Clinical trials are well-organized
and therefore may cause infertility, a man tak-
studies that evaluate the treatment’s efficacy
ing this drug should switch to another 5-ASA
and safety. Most clinical trials are classified into
compound (with his doctor’s approval). Discuss
one of three phases:
all medications with your doctor.
• Phase I trials evaluate how a new drug should
For more information on Pregnancy and be given (by mouth, injected into the blood,
IBD, view our pregnancy fact sheet at or injected into the muscle), how often, and
www.crohnscolitisfoundation.org/brochures. what doses are safe to use.
• Phase II trials test the safety of the new drug,

Participation in Clinical as well as evaluate how well the drug works.

• Phase III trials test how well the new drug
Trials works and the best dose. Trial participants
are divided into groups where one receives
Researchers working in laboratories all over the medication and a “control” group receives
the world are devoted to the scientific investi- a placebo (no chemical properties) or
gation of Crohn’s disease and ulcerative colitis standard-of-care therapy.
in the hope of finding cures.
With the ever-increasing number of clinical
That is good news when it comes to the devel- trials of potential new IBD therapies, there is
opment of new therapies for these diseases. an even greater need for patient participation
New discoveries over the past decade have to see if these experimental therapies work.
led to huge strides in the fields of immunology

18 19
Patients often find participation in a clinical trial Resource Center (IBD Help Center). Through a
a rewarding experience. Anyone can participate toll-free number (1-888-694-8872), e-mail, or
as long as they meet the criteria for that par- live chat on our website (www.crohnscolitis-
ticular trial. Those criteria may include type of foundation.org), master’s degree level health
symptoms, location or stage of disease, and age. education professionals answer questions and
direct people to resources that are important
Should you participate in a clinical trial of a to help improve their quality of life.
new drug for Crohn’s disease or ulcerative
colitis? To make that decision, you need to be
fully informed about that trial and the drug Tools and Resources
that is being tested. All clinical trials have both
benefits and risks associated with them. The You and your healthcare provider share one
advances in current IBD treatment are possible important goal: to get your IBD under control
only because people before you participated in and keep it that way.
clinical trials. Find out more about clinical trials
through the Foundation’s Clinical Trials Com- One of the best ways to accomplish that is by
munity at www.crohnscolitisfoundation.org/ carefully following the medication regimen
clinical-trials-community. your doctor has prescribed for you. To help
you, we have provided a medication log toward
the end of this brochure to track your treat-
Improving Quality of Life ment and care over time. We suggest you keep
it somewhere handy so you can access it easily.
The Crohn’s & Colitis Foundation has estab- The log also serves as a convenient reference
lished a range of educational materials and for when you speak with your healthcare
programs designed to increase awareness providers. Also included on the next page are
about Crohn’s and ulcerative colitis. medication profiles. The profiles include infor-
mation about commonly used IBD medications.
We know living with IBD can be difficult, but
the right resources and support can make For a complete, up-to-date listing of all IBD
day-to-day living more comfortable. That’s medications visit www.ibdmedicationguide.
why the Foundation has developed a compre- org and for a listing of recently approved IBD
hensive, free online community (www.crohn- medications visit www.crohnscolitisfounda-
scolitiscommunity.org) to provide the support tion.org/brochures.
individuals need in managing their condition.
In-person support groups are also available in These profiles do not contain all available infor-
many locations nationwide. Find groups in your mation about the risks, benefits, and additional
area at www.crohnscolitisfoundation.org, or warnings for each medication listed. Please
call 1-888-694-8872. speak with your healthcare provider for more
detailed information. This information is not
We recognize the importance of distributing intended to replace medical advice from your
unbiased, accurate, and authoritative informa- doctor or other healthcare provider.
tion in order to provide education of the finest
quality. One avenue used to accomplish this
is the Irwin M. and Suzanne R. Rosenthal IBD

20 21
Aminosalicylates (5-ASA) Generic Name: Olsalazine

Generic Name: Balsalazide Brand Name(s): Dipentum®

Brand Name(s): Colazal,® Giazo™ Drug Class: Aminosalicylates (5-ASA)

Drug Class: Aminosalicylates (5-ASA) Recommendations for Pregnancy: Low risk

Recommendations for Pregnancy: Low risk How Taken: Oral

How Taken: Oral Used for: Ulcerative colitis

Used for: Mild-to-moderate ulcerative colitis Medication Indication: For the maintenance of remis-
sion of ulcerative colitis in patients who are intolerant
Medication Indication: Used to treat the signs and symp- of sulfasalazine.
toms of mildly-to-moderately active ulcerative colitis in
patients five years of age and older. Also, prescribed for Most Common Side Effects: Stomach upset, bloating,
off-label use for treatment of Crohn’s disease. loss of appetite, blurred vision, headache, pain in joints,
and dizziness.
Most Common Side Effects: Headaches, abdominal
pain, diarrhea, nausea, vomiting, respiratory infection, Other: Avoid Dipentum® if you are allergic to medicines
and arthralgia. containing salicylates, such as aspirin, or mesalamine.

Other: Avoid balsalazide if you are allergic to medicines

containing salicylates, such as aspirin, or mesalamine Generic Name: Sulfasalazine
(Rowasa,® Asacol® HD, Pentasa,® Canasa,® Lialda,™
Apriso,™ and Delzicol™). Kidney toxicity has been rarely Brand Name(s): Azulfidine®
reported. Use caution if there is active renal disease. Drug Class: Aminosalicylates (5-ASA)

Recommendations for Pregnancy: Considered low risk,

Generic Name: Mesalamine give folate 2mg daily

Brand Name(s): Apriso,™ Asacol® HD, Canasa,® How Taken: Oral

Delzicol,™ Lialda,™ Pentasa,® Rowasa®
Used for: Ulcerative colitis
Drug Class: Aminosalicylates (5-ASA)
Medication Indication: For the treatment of
Recommendations for Pregnancy: Limited human data: mild-to-moderate ulcerative colitis, and as adjunctive
Low risk therapy in severe ulcerative colitis, and for the prolon-
gation of the remission period between acute attacks
How Taken: Oral or rectal of ulcerative colitis. Also, off-label use for treatment
Used for: Mild-to-moderate ulcerative colitis of Crohn’s disease.

Medication Indication: Mesalamine delayed-release Most Common Side Effects: Diarrhea, headache, loss of
tablets or capsules and extended-release capsules may appetite, upset stomach, vomiting, and stomach pain.
be used to treat ulcerative colitis that affects any part Other: Low sperm count and infertility have been
of the colon. Mesalamine suppositories and enemas observed in men treated with sulfasalazine; however,
can be used to treat inflammation of the lower part of withdrawal of the drug appears to reverse these effects.
the colon. Also used as off-label treatment of Crohn’s
disease, although the benefits are unproven.

Most Common Side Effects: Headache, muscle or joint

pain, aching, tightness or stiffness, back pain, nausea,
vomiting, heartburn, burping, constipation, gas, dry
mouth, sore throat, cough, flu-like symptoms, stuffy
head, runny nose, ear pain, anxiety, sweating, acne,
slight hair loss, and diarrhea.

Other: Caution should be used for individuals with

pre-existing liver disease or renal impairment.

22 23
Antibiotics Biologics
Generic Name: Ciprofloxacin Generic Name: Adalimumab

Brand Name(s): Cipro,® Proquin® Brand Name(s): Humira®

Drug Class: Antibiotics Drug Class: Biologics

Recommendations for Pregnancy: Avoid; potential Recommendations for Pregnancy: Low risk
toxicity to cartilage
How Taken: Injection under the skin (subcutaneous)
How Taken: Oral and intravenous (IV)
Used for: Moderate-to-severe Crohn’s disease and
Used for: Active Crohn’s disease and pouchitis ulcerative colitis in adults and pediatric patients age
6 and older.
Medication Indication: May help control symptoms of
IBD by reducing intestinal bacteria. Effective as a long- Medication Indication: Reduces signs and symptoms
term therapy for some patients with Crohn’s disease and induces and maintains clinical response in patients
who have fistulas or recurrent abscesses near their with moderate-to-severely active Crohn’s disease and
anus. Also effective for people who develop pouchitis. ulcerative colitis who have had an inadequate response
to conventional therapy.
Most Common Side Effects: Nausea, vomiting, stomach
pain, indigestion, diarrhea, headache, nervousness, agita- Most Common Side Effects: Injection site reactions
tion, anxiety, and difficulty falling asleep or staying asleep. such as redness, rash, swelling, itching, pain, or bruising;
upper respiratory infections (including sinus infections);
Other: Contains fluoroquinolone, an ingredient asso- headaches, rash, and nausea.
ciated with an increased risk of tendonitis and tendon
rupture. It may also cause worsening of myasthenia Other: There have been reports of serious infections
gravis (a disease that causes muscle weakness). associated with adalimumab, including tuberculosis
(TB) and other infections, such as viruses, fungi, and
other bacteria that have spread throughout the body.
Generic Name: Metronidazole On rare occasions, certain types of cancer, including
lymphoma, have been reported.
Brand Name(s): Flagyl®

Drug Class: Antibiotics

Recommendations for Pregnancy: Would avoid in first

trimester only, given limited efficacy in IBD and risk of
cleft palate

How Taken: Oral

Used for: Active Crohn’s disease and pouchitis

Medication Indication: Off-label use of metronidazole

may help control symptoms of IBD by reducing intesti-
nal bacteria. Effective as a long-term therapy for some
patients with Crohn’s disease who have fistulas or
recurrent abscesses near their anus. Also effective for
people who develop pouchitis.

Most Common Side Effects: Nausea, vomiting, loss

of appetite, a metallic taste, diarrhea, dizziness, head-
aches, peripheral neuropathy, and discolored urine
(dark or reddish brown).

24 25
Generic Name: Adalimumab-abdn Generic Name: Adalimumab-adaz

Brand Name(s): CyltezoTM (this drug is a biosimilar to Brand Name(s): Hyrimoz™ (This drug is a biosimilar to
Humira®) Humira®)

Drug Class: Biologics Drug Class: Biologics

Recommendations for Pregnancy: Effects to fetus are Recommendations for Pregnancy: Effects to fetus are
unknown. unknown.

How Taken: Injection under the skin (subcutaneous) How Taken: Injection under the skin (subcutaneous)

Used for: Moderate-to-severe Crohn’s disease and Used for: Moderate-to-severe Crohn’s disease and
ulcerative colitis in adults and moderate-to-severe ulcerative colitis in adults and moderate-to-severe
Crohn’s disease in pediatric patients age 6 and older. Crohn’s disease in pediatric patients age 6 and older.

Medication Indication: Reduces signs and symptoms Medication Indication: Reduces signs and symptoms
and induces and maintains clinical response in adult and induces and maintains clinical response in adults
patients with moderately-to-severely active Crohn’s dis- patients with moderately-to-severe active Crohn’s
ease and ulcerative colitis who have had an inadequate disease and ulcerative colitis.
response to conventional therapy.
Most Common Side Effects: Injection site reactions
Most Common Side Effects: Injection site reactions such as redness, rash, swelling, itching, pain, or bruising;
such as redness, rash, swelling, itching, pain, or bruising; upper respiratory infections (including sinus infections);
upper respiratory infections (including sinus infections); headaches, rash, and nausea.
headaches, rash, and nausea.
Other: Serious infections have included tuberculosis
Other: Serious infections have included tuberculosis (TB) and infections caused by viruses, fungi. Lupus-like
(TB) and infections caused by viruses, fungi, and other reactions, and liver problem are rare but have also been
bacteria that have spread throughout the body. Lu- reported. Another rare risk is cancer known as hepato-
pus-like reactions and liver problems are rare but have splenic T-cell lymphoma. Adalimumab-adaz is currently
also been reported. Another rare risk is cancer known not available in the US market.
as hepatosplenic T-cell lymphoma. Adalimumab-abdn is
currently not available in the US market.

26 27
Generic Name: Adalimumab-atto Generic Name: Certolizumab pegol

Brand Name(s): Amjevita® (this drug is a biosimilar to Brand Name(s): Cimzia®

Humira® )
Drug Class: Biologics
Drug Class: Biologics
Recommendations for Pregnancy: Low risk
Recommendations for Pregnancy: Effects to fetus are
unknown. How Taken: Injection under the skin (subcutaneous)

How Taken: Injection under the skin (subcutaneous) Used for: Moderate-to-severe Crohn’s disease

Used for: Moderate-to-severe Crohn’s disease and Medication Indication: Reduces signs and symptoms,
ulcerative colitis in adults and moderate-to-severe and maintains clinical response, in adult patients with
Crohn’s disease in pediatric patients age 6 and older. moderately-to-severely active Crohn’s disease who have
had an inadequate response to conventional therapy.
Medication Indication: Reduces signs and symptoms
and induces and maintains clinical response in adult Most Common Side Effects: Swelling, weight gain, rash,
patients with moderately-to-severely active Crohn’s dis- upper respiratory tract infection, urinary tract infection,
ease and ulcerative colitis who have had an inadequate and joint pain.
response to conventional therapy. Other: There have been reports of serious infections
Most Common Side Effects: Injection site reactions associated with certolizumab pegol, including tubercu-
such as redness, rash, swelling, itching, pain, or bruising; losis (TB) and other infections such as viruses, fungi,
upper respiratory infections (including sinus infections); and other bacteria that have spread throughout the
headaches, rash, and nausea. body. On rare occasions certain types of cancer, includ-
ing lymphoma, have been reported.
Other: Serious infections have included tuberculosis
(TB) and infections caused by viruses, fungi and other
bacteria that have spread throughout the body. Lu- Generic Name: Golimumab
pus-like reactions and liver problems are rare but have
also been reported. Another rare risk is cancer known Brand Name(s): Simponi®
as hepatosplenic T-cell lymphoma. Adalimumab-atto is
Drug Class: Biologics
currently not available in the US market.
Recommendations for Pregnancy: Low risk

How Taken: Injection under the skin (subcutaneous)

Used for: Moderate-to-severe ulcerative colitis in adults

Medication Indication: Induces and maintains a clinical

response in patients with moderate-to-severe active
ulcerative colitis when certain other medications have
not worked well enough or cannot be tolerated, or if it
is necessary to continue taking steroid medications.

Most Common Side Effects: Upper respiratory in-

fections, such as runny nose, sore throat, hoarseness
or laryngitis; injection site reactions, such as redness,
swelling, itching, pain, bruising and tingling; and viral
infections, such as flu and oral cold sores.

Other: There have been reports of serious infections

while taking golimumab, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses
that spread throughout the body. Lymphoma and
other malignancies have been reported in children and
adolescent patients treated with TNF blockers, of which
golimumab is a member.

28 29
Generic Name: Infliximab Generic Name: Infliximab-dyyb

Brand Name(s): Remicade® Brand Name(s): Inflectra™ (This drug is a biosimilar

to Remicade®)
Drug Class: Biologics
Drug Class: Biologics
Recommendations for Pregnancy: Low risk
Recommendations for Pregnancy: Low risk
How Taken: Intravenous (IV) infusion
How Taken: Intravenous (IV) infusion
Used for: Moderate-to-severe Crohn’s disease and
ulcerative colitis in adults and pediatric patients age Used for: Moderate-to-severe Crohn’s disease and
6 and older ulcerative colitis in adults and pediatric patients age
6 and older
Medication Indication: Indicated for reducing signs
and symptoms, and inducing and maintaining clinical Medication Indication: Indicated for reducing signs and
remission, in adult and pediatric patients over the age symptoms, and inducing and maintaining clinical remis-
of 6 with moderately-to-severely active Crohn’s disease sion, in adult and pediatric patients over the age of 6
who have had an inadequate response to conventional with moderately-to-severely active Crohn’s disease who
therapy. Infliximab is indicated for reducing the number have had an inadequate response to conventional thera-
of draining enterocutaneous and rectovaginal fistulae py. Infliximab-dyyb is indicated for reducing the number
and maintaining the fistulizing closure in patients with of draining enterocutaneous and rectovaginal fistulae
Crohn’s disease. and maintaining the fistulizing closure in patients with
Crohn’s disease.
Infliximab is indicated for reducing signs and symptoms,
achieving clinical remission and mucosal healing, and Infliximab-dyyb is indicated for reducing signs and
eliminating corticosteroid use in adult and pediatric symptoms, achieving clinical remission and mucosal
patients over the age of 6 with moderately-to-severely healing, and eliminating corticosteroid use, in adult and
active ulcerative colitis who have had an inadequate pediatric patients over the age of 6 with moderate-
response to conventional therapy. ly-to-severely active ulcerative colitis who have had an
inadequate response to conventional therapy.
Most Common Side Effects: Infusion reactions, such as
hives, redness, chest pressure, itching and swelling of the Most Common Side Effects: Infusion reactions, such as
lips and throat and shortness of breath; respiratory infec- hives, redness, chest pressure, itching and swelling of
tions, such as sinus infections and sore throat; headache; the lips and throat and shortness of breath; respiratory
coughing; stomach pain; nausea; and back pain. infections, such as sinus infections and sore throat; head-
ache; coughing; stomach pain; nausea; and back pain.
Other: There have been reports of serious infections
associated with infliximab, including tuberculosis (TB) Other: There have been reports of serious infections
and other infections such as viruses, fungi, and other associated with Infliximab products, including tubercu-
bacteria that have spread throughout the body. On rare losis (TB) and other infections such as viruses, fungi,
occasions certain types of cancer, including lymphoma, and other bacteria that have spread throughout
have been reported. the body. On rare occasions certain types of cancer,
including lymphoma, have been reported.

30 31
Generic Name: Infliximab-qbtx Generic Name: Natalizumab

Brand Name(s): IXIFI™ (This drug is a biosimilar Brand Name(s): Tysabri®

to Remicade®)
Drug Class: Biologics
Drug Class: Biologics
Recommendations for Pregnancy: Based on animal
Recommendations for Pregnancy: Low risk data, may cause fetal harm

How Taken: Intravenous (IV) infusion How Taken: Intravenous (IV) infusion

Used for: Moderate-to-severe Crohn’s disease and Used for: Moderate-to-severe Crohn’s disease
ulcerative colitis in adults and pediatric patients age
6 and older Medication Indication: Reduces signs and symptoms,
and induces and maintains clinical remission in adult
Medication Indication: Indicated for reducing signs and patients with moderately-to-severely active Crohn’s dis-
symptoms, and inducing and maintaining clinical remis- ease who have had an inadequate response to conven-
sion, in adult and pediatric patients over the age of 6 tional therapy, including inhibitors of TNF-alpha.
with moderately-to-severely active Crohn’s disease who
have had an inadequate response to conventional thera- Most Common Side Effects: Infections such as in the
py. Infliximab-qbtx is indicated for reducing the number urinary tract or upper respiratory tract, headache,
of draining enterocutaneous and rectovaginal fistulae tiredness, depression, joint pain, diarrhea, and stomach
and maintaining the fistulizing closure in patients with area pain.
Crohn’s disease. Other: Natalizumab increases the risk of progressive
Infliximab-qbtx is indicated for reducing signs and multifocal leukoencephalopathy (PML), a rare brain
symptoms, achieving clinical remission and mucosal infection that usually causes death or severe disability.
healing, and eliminating corticosteroid use, in adult and Your chance of getting PML increases if you have been
pediatric patients over the age of 6 with moderate- exposed to John Cunningham Virus (JCV). Your doctor
ly-to-severely active ulcerative colitis who have had an may do a blood test to check if you have been exposed
inadequate response to conventional therapy. to JCV before you start receiving natalizumab or during
your treatment. The risk of PML is higher in patients
Most Common Side Effects: Infusion reactions, such as who are virus carriers (anti-JCV positive), have received
hives, redness, chest pressure, itching and swelling of other immunosuppressives, or have been on natalizum-
the lips and throat and shortness of breath; respiratory ab for a long time, especially longer than two years.
infections, such as sinus infections and sore throat; head- Natalizumab may also cause liver damage and allergic
ache; coughing; stomach pain; nausea; and back pain. reactions.
Other: There have been reports of serious infections
associated with infliximab products, including tubercu-
losis (TB) and other infections such as viruses, fungi,
and other bacteria that have spread throughout the
body. On rare occasions certain types of cancer, includ-
ing lymphoma, have been reported.

32 33
Generic Name: Ustekinumab Corticosteroids
Brand Name(s): Stelara® Generic Name: Budesonide
Drug Class: Biologics Brand Name(s): Entocort® EC, UCERIS™
Recommendations for Pregnancy: Limited human Drug Class: Corticosteroids
data; No adverse effects or risks in animal studies
Recommendations for Pregnancy: Low risk: limited
How Taken: Intravenous (IV) for initial dosages, injection human data
for maintenance therapy
How Taken: Oral
Used for: Moderate-to-severe Crohn’s disease
Used for: Mild-to-moderate active Crohn’s disease and
Medication Indication: For the treatment of adults with ulcerative colitis
moderate-to-severe active Crohn’s disease who’ve had
an inadequate response to conventional therapy Medication Indication: Entocort® EC is used for the
treatment of mild-to-moderate active Crohn’s dis-
Most Common Side Effects: Upper respiratory infec- ease involving the ileum and/or the ascending colon.
tion, headache, tiredness, itching, vomiting, vaginal UCERIS™ is used for induction of remission in active
yeast infection, urinary tract infection, and redness at mild-to-moderate ulcerative colitis.
injection site
Most Common Side Effects: Headache, respiratory
Other: Rare side effects include reversible posterior infection, nausea, and symptoms of hypercorticism (too
leukoencephalopathy syndrome (this is a reversible many steroids in your body). These symptoms include
syndrome that can include headache, altered mental an increase in the size of the face and neck, acne, bruis-
functioning, seizures, and loss of vision). ing, and weight gain.

Other: Budesonide is a nonsystemic corticosteroid,

Generic Name: Vedolizumab which means it is released primarily in the gastrointesti-
nal (GI) tract, therefore causing fewer side effects.
Brand Name(s): Entyvio®
Avoid eating grapefruit or drinking grapefruit juice
Drug Class: Biologics regularly as it can increase the amount of budesonide
in your body.
Recommendations for Pregnancy: No human data;
Likely low risk

How Taken: Intravenous (IV) infusion Generic Name: Methylprednisolone

Used for: Moderate-to-severe Crohn’s disease and Brand Name(s): A-Methapred,® Depo-Medrol,® Medrol
ulcerative colitis Dosepak,® Solu-Medrol®

Medication Indication: For the treatment of adults Drug Class: Corticosteroids

with moderate-to-severe active Crohn’s disease and
Recommendations for Pregnancy: Low risk: possible
ulcerative colitis who have had an inadequate response
increased risk of cleft palate, adrenal insufficiency,
with, lost response to or were intolerant to a tumor
premature rupture of membranes
necrosis factor (TNF) blocker or immunomodulatory
or had an inadequate response with, were intolerant to, How Taken: Oral or intravenous
or demonstrated dependence on corticosteroids.
Used for: Moderate-to-severe Crohn’s disease and
Most Common Side Effects: Injection site reactions, ulcerative colitis
nasapharyngitis, headache, pain in joints, nausea, fever,
upper respiratory infection, and fatigue. Medication Indication: For the management of active
Crohn’s disease and ulcerative colitis to reduce signs
and symptoms.

Most Common Side Effects: Upset stomach, stomach

irritation, vomiting, headache, dizziness, insomnia,
restlessness, depression, anxiety, and acne.

34 35
Generic Name: Prednisolone Immunomodulators
Brand Name(s): Oraped,® Prelone,® and Pediapred® Generic Name: Azathioprine
Drug Class: Corticosteroids Brand Name(s): Azasan,® Imuran®
Recommendations for Pregnancy: Low risk: possible Drug Class: Immunomodulators
increased risk of cleft palate, adrenal insufficiency,
premature rupture of membranes Recommendations for Pregnancy: Data in IBD
transplant literature suggest low risk
How Taken: Oral
How Taken: Oral, not given by intravenous (IV) for IBD
Used for: Moderate-to-severe Crohn’s disease and UC
Used for: Ulcerative colitis and Crohn’s disease
Medication Indication: Management of active Crohn’s
disease and UC to reduce signs and symptoms. Medication Indication: Off-label use for the manage-
ment of moderate and active inflammatory bowel
Most Common Side Effects: Upset stomach, stomach disease to reduce signs and symptoms.
irritation, vomiting, headache, dizziness, insomnia,
restlessness, depression, anxiety, and acne. Most Common Side Effects: Upset stomach, vomiting,
diarrhea, and muscle aches.

Generic Name: Prednisone Other: Periodic blood work is necessary when taking
Imuran to monitor the liver and blood counts. Infections,
Brand Name(s): Deltasone® including lymphoma and pancreatitis, have been rarely
reported.
Drug Class: Corticosteroids

Recommendations for Pregnancy: Low risk: possible

increased risk of cleft palate, adrenal insufficiency, Generic Name: Cyclosporine
premature rupture of membranes Brand Name(s): Gengraf,® Neoral,® Sandimmune®
How Taken: Oral Drug Class: Immunomodulators
Used for: Moderate-to-severe Crohn’s disease and UC Recommendations for Pregnancy: Low risk
Medication Indication: For the management of active How Taken: Oral and intravenous (IV) infusion
Crohn’s disease and ulcerative colitis to reduce signs
and symptoms. Used for: Ulcerative colitis

Most Common Side Effects: Headache, dizziness, Medication Indication: Off-label use for the manage-
difficulty falling asleep or staying asleep, inappropriate ment of moderate-to-severe ulcerative colitis
happiness, extreme changes in mood, changes in
Most Common Side Effects: Headache; diarrhea; heart-
personality, bulging eyes, and acne.
burn; gas; increased hair growth; acne; flushing; shaking
of a part of your body that you cannot control; burning
or tingling in the hands, arms, feet, or legs; muscle or
joint pain; cramps.

Other: Avoid drinking grapefruit juice or eating grape-

fruit, as this can alter drug levels. Due to increased risk
for hypertension and kidney dysfunction, close mon-
itoring is needed. Small increased risk for lymphoma,
skin cancer, and other cancers. Small increased risk for
infections and liver dysfunction.

36 37
Generic Name: Mercaptopurine (6-MP) Generic Name: Tacrolimus

Brand Name(s): Purinethol® Brand Name(s): Prograf®

Drug Class: Immunomodulators Drug Class: Immunomodulators

Recommendations for Pregnancy: Data in IBD Recommendations for Pregnancy: Use if mother’s
transplant literature suggests low risk health mandates

How Taken: Oral How Taken: Oral and intravenous (IV)

Used for: Ulcerative colitis and Crohn’s disease Used for: Moderate-to-severe Crohn’s disease and
ulcerative colitis
Medication Indication: Off-label use for the manage-
ment of moderate and active inflammatory bowel Medication Indication: Off-label use for the manage-
diseases to reduce signs and symptoms. ment of active Crohn’s disease and ulcerative colitis to
reduce signs and symptoms.
Most Common Side Effects: Headache, weakness,
or achiness; darkening of the skin; loss of appetite Most Common Side Effects: Headache, hypertension,
or weight. diarrhea, constipation, nausea, vomiting, heartburn,
stomach pain, loss of appetite, difficulty falling asleep or
Other: Periodic blood work is necessary when taking staying asleep, dizziness, weakness, back or joint pain,
mercaptopurine to monitor the liver and blood counts. burning, numbness, pain or tingling in the hands or feet,
Infection, a small risk of lymphoma, and a small risk of rash, and itching.
pancreatitis have been noted.
Other: Avoid eating grapefruit or drinking grapefruit
juice while taking tacrolimus. There is a small risk of
Generic Name: Methotrexate infections, skin cancer, or kidney dysfunction; close
monitoring is needed.
Brand Name(s): Rheumatrex®

Drug Class: Immunomodulators

Recommendations for Pregnancy: Contraindicated: Janus Kinase Inhibitors (JAK Inhibitors)

teratogenic

How Taken: Oral and injection under the skin Generic Name: Tofacitinib
(subcutaneous); It can be administered intramuscularly
in Crohn’s disease Brand Name(s): Xeljanz®

Used for: Active Crohn’s disease Drug Class: Janus Kinase Inhibitors

Medication Indication: Off-label use for the manage- Recommendations for Pregnancy: Data in IBD is
ment of active Crohn’s disease to reduce signs and lacking; rare birth defects and miscarriages in non-IBD
symptoms. populations

Most Common Side Effects: Nausea, hair loss, fatigue, How Taken: Oral
headache, dizziness, drowsiness, and mouth sores. Used for: Ulcerative colitis
Other: It is not recommended for individuals with Medication Indication: Moderate-to-severe ulcerative
pre-existing conditions. Methotrexate is known to colitis to reduce signs and symptoms. While on tofaci-
cause birth defects; it is recommended for patients to tinib, you should avoid the live shingles vaccine.
stop taking methotrexate at least three months prior
to planned conceptions. Additionally, methotrexate Most Common Side Effects: Headache, upper respira-
reduces the absorption of folic acid so supplementation tory infection, nasopharyngitis
may be necessary.
Other: Use of tofacitinib in combination with biological
therapies for UC or with potent immunosuppressants,
such as azathioprine and cyclosporine, is not recom-
mended. When taking tofacitinib, there is a risk of
infection (especially with herpes zoster or shingles) and
a very small risk of gastrointestinal perforations.

38 39
Glossary Fistula: A tunnel starting from the intestine to
another area of the body, such as another area
of the intestine, bladder, vagina, or skin.
Abscess: A collection of pus (dead white blood
cells) that has accumulated in a cavity formed
Flare or flare-up: Presence of inflammation
by the tissue because of an infectious process
and symptoms.
(usually caused by bacteria, fungi, or parasites).
Gastrointestinal: Adjective referring
Aminosalicylates: See page 6.
collectively to the stomach and small and
Antibiotics: Drugs that fight infections, such as large intestines.
metronidazole and ciprofloxacin.
GI tract: Short for gastrointestinal tract.
Anus: Opening at the end of the rectum that
allows solid waste to be eliminated. Immune system: The body’s natural defense
system that fights against disease.
Biologic therapies: See page 8.
Immunomodulators: See page 7.
Chronic: Long lasting or long term.
Inflammation: A response to tissue injury that
Colon: The large intestine. causes redness, swelling, and pain.

Corticosteroids: See page 6. Inflammatory bowel diseases (IBD): A term

referring to a group of disorders, including
Crohn’s disease: A chronic inflammatory dis- Crohn’s disease (inflammation anywhere in
ease that primarily involves the small and large the gastrointestinal tract) and ulcerative colitis
intestine, but that can affect other parts of the (inflammation limited to the colon).
digestive system as well. It is named for Dr.
Burrill Crohn, the American gastroenterologist Intestine: The long, tubelike organ in the abdo-
who first described the disease in 1932. men that completes the process of digestion. It
consists of the small and large intestines.
Diarrhea: Passage of excessively frequent or
excessively liquid stools. Large intestine: Also known as the colon. Its
primary function is to absorb water and get rid
Extraintestinal complications: Complications of solid waste.
that occur outside of the intestine, such as
arthritis or skin rashes. In some people, these NSAIDs: Nonsteroidal anti-inflammatory drugs
may actually be the first signs of IBD, appearing such as aspirin, ibuprofen, ketoprofen, and
even before the bowel symptoms. In others, naproxen.
they may occur right before a flare-up of the
disease. Off-label: Use of an FDA-approved drug for an
indication other than that for which the drug
FDA: The U.S. Food and Drug Administration. was approved originally.

40 41
Oral: By mouth. Notes:
Perianal: Located around the anus, the open-
ing of the rectum, to the outside of the body.

Peripheral neuropathy: Nerve damage in the

hands or feet that can result in weakness,
numbness, or pain.

Pouchitis: Inflammation of the lining of the in-

ternal pouch (formed from the small intestine).

Rectal: Having to do with the rectum.

Rectum: Lowest portion of the colon.

Remission: Periods in which symptoms disap-

pear or decrease and good health returns.

Small intestine: Connects to the stomach and

large intestine; absorbs nutrients.

Subcutaneous: Injected under the skin.

Teratogenic: Capable of causing birth defects.

Toxicity: The degree to which a substance

is harmful.

Ulcer: A sore on the skin or in the lining of the

GI tract.

Ulcerative colitis: A relatively common disease

that causes inflammation of the large intestine
(the colon).

42 43
Notes: About the Crohn’s &
Colitis Foundation
Established in 1967, the Crohn’s & Colitis
Foundation is a non-profit, volunteer-driven
organization dedicated to finding the cures
for Crohn’s disease and ulcerative colitis, and
improving the quality of life of children and
adults affected by these diseases.

Since our founding, the Foundation has re-

mained at the forefront of research in Crohn’s
disease and ulcerative colitis. Today, we fund
cutting-edge studies at major medical institu-
tions, nurture investigators at the early stages
of their careers, and finance underdeveloped
areas of research.

In addition, the Crohn’s & Colitis Foundation

provides a comprehensive series of education
programs, printed and online resources, sup-
port services and advocacy programs to mem-
bers of the IBD community, including patients
and caregivers.

We can help! Contact us at:

888-MY-GUT-PAIN
(888-694-8872)
[email protected]
www.crohnscolitisfoundation.org

Credits:
Reviewers:
Sophie Balzora, MD, Heba Iskandar, MD,
Kian Keyashian, MD, Jami Kinnucan, MD,
and Sasha Taleban, MD
Contributors:
Tom DeBourcy and Gay Klapman
Design & Layout:
Rubicon Design Associates

44
This brochure is supported by the Elizabeth
Morse Charitable Trust. Additional support
is provided through the Crohn’s & Colitis
Foundation’s annual giving program and donors.

733 Third Avenue

Suite 510
New York, NY 10017
800-932-2423

www.crohnscolitisfoundation.org

The Crohn’s & Colitis Foundation is a nonprofit organiza-

tion that relies on the generosity of private contributions
to advance its mission to cure Crohn’s disease and ulcer-
ative colitis, and to improve the quality of life of children
and adults affected by these diseases.

03/2021