Acitretin

Acitretin is a prescription medication used to treat the symptoms of psoriasis.

• Acitretin is available under the following different brand names: Soriatane

Common side effects of Acitretin include:

• chapped lips,
• dry mouth,
• itchy or scaly skin,
• weak nails,
• fragile skin,
• peeling skin on the hands and feet,
• hair loss,
• dry eyes,
• discomfort while wearing contact lenses,
• dry or runny nose,
• nosebleeds,
• joint pain, and
• tight muscles

Serious side effects of Acitretin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• mood changes,
• depression,
• aggression,
• unusual thoughts or behavior,
• thoughts of self-harm,
• chest pain,
• dizziness,
• nausea,
• shortness of breath,
• sudden numbness or weakness (especially on one side of the body),
• sudden severe headache,
• problems with speech or balance,
• swelling or warmth in one or both legs,
• increased thirst,
• increased urination,
• dry mouth,
• fruity breath odor,
• headache,
• blurred vision,
• ringing in the ears,
• dizziness,
• pain behind the eyes,
• vomiting,
• loss of appetite,
• dark urine,
• yellowing of the skin or eyes (jaundice)
• loss of feeling in the hands or feet,
• trouble moving,
• pain in the back, joints, muscles, or bones,
• itching,
• redness,
• pain,
• swelling or peeling of the skin,
• sudden swelling,
• rapid weight gain,
• fever,
• muscle pain, and
• light-headedness

Rare side effects of Acitretin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 10mg
• 25mg

Psoriasis

• Adult dosage
• 25-50 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Acitretin has severe interactions with the following drugs:
  • demeclocycline
  • doxycycline
  • ethanol
  • methotrexate
  • minocycline
  • omadacycline
  • sarecycline
  • tetracycline
• Acitretin has serious interactions with the following drugs:
  • aminolevulinic acid oral
  • aminolevulinic acid topical
  • medroxyprogesterone
  • methyl aminolevulinate
  • norethindrone
  • norethindrone acetate
• Acitretin has moderate interactions with the following drugs:
  • nitazoxanide
  • ospemifene
• Acitretin has minor interactions with the following drug:
  • vitamin A

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to retinoids (.g, angioedema, urticaria), parabens
• Coadministration with methotrexate (increased risk for hepatitis)
• Coadministration with tetracyclines (increases ICP, pseudotumor cerebri)
• Alcohol (see Black Box Warnings)
• Severely impairment of liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see Black Box Warnings)
• Pregnancy: teratogenic (see Black Box Warnings)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acitretin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acitretin?”

Cautions

• Check LFTs 1 day before starting, pregnancy test 2 weeks before starting therapy
• Hyperostosis reported with long-term treatment
• New or progression of preexisting vertebral/skeletal abnormalities (.g, degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of cervical disc space)
• Exfoliative dermatitis and erythroderma reported
• Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm are reported in patients taking retinoids; since other factors may contribute to these events, it is not known if they are related to therapy; counsel patients to stop taking this drug and to notify their prescriber immediately if they experience psychiatric symptoms
• Minimize exposing treated areas to the sun or other UV light; significantly lower doses of phototherapy are required when this drug is used; effects on the stratum corneum induced by this drug can increase the risk of erythema (burning)

Ophthalmic effects

• Ophthalmic conditions include dry eyes, irritation of the eyes, and brow and lash loss; Bell’s palsy, blepharitis and/or crusting of lids, blurred vision, conjunctivitis, corneal epithelial abnormality, cortical cataract, decreased night vision, diplopia, itchy eyes or eyelids, nuclear cataract, pannus, papilledema, photophobia, posterior subcapsular cataract, recurrent sties, and subepithelial corneal lesions, reported; patients treated experiencing visual difficulties should discontinue the drug and undergo ophthalmologic evaluation

Pseudomotor cerebri

• Retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension); some events involved concomitant use of isotretinoin and tetracyclines; however, an event seen in a single patient was not associated with tetracycline use
• Early signs and symptoms include papilledema, headache, nausea and vomiting, and visual disturbances; patients with these signs and symptoms should be examined for papilledema and, if present, therapy should be discontinued immediately and be referred for neurological evaluation and care
• Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated

Capillary leak syndrome

• Capillary leak syndrome, a potential manifestation of the retinoic acid syndrome, has been reported in patients receiving this drug; features of this syndrome may include localized or generalized edema with secondary weight gain, fever, and hypotension
• Rhabdomyolysis and myalgias have been reported in association with capillary leak syndrome, and laboratory tests may reveal neutrophilia, hypoalbuminemia, and an elevated hematocrit; discontinue therapy if capillary leak syndrome develops during therapy

Skeletal abnormalities

• In adults receiving long-term treatment, appropriate examinations should be periodically performed given possible ossification abnormalities; as the frequency and severity of iatrogenic bony abnormality in adults is low, periodic radiography is only warranted in presence of symptoms or long-term use
• If such disorders arise, a continuation of therapy should be discussed with the patient on basis of careful risk/benefit analysis; in clinical trials abnormalities of the spine that showed new changes or progression of pre-existing findings were reported
• Changes included degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of cervical disc space; De novo changes (formation of small spurs) were also reported

Lipids and possible cardiovascular effects

• Blood lipid determinations should be performed before the drug is administered and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, usually within 4 to 8 weeks; elevation in triglycerides and cholesterol reported in clinical trials, respectively; decreased high-density lipoproteins (HDL) also reported in 40% of subjects; these effects of were generally reversible upon cessation of therapy
• Increased tendency to develop hypertriglyceridemia associated with disturbances of lipid metabolism, diabetes mellitus, obesity, increased alcohol intake, or familial history of these conditions; because of the risk of hypertriglyceridemia, serum lipids must be more closely monitored in high-risk patients and during long-term treatment
• Hypertriglyceridemia and lowered HDL may increase a patient’s cardiovascular risk status; although no causal relationship established, there have been post-marketing reports of acute myocardial infarction or thromboembolic events in patients on therapy
• In addition, the elevation of serum triglycerides to greater than 800 mg per dL has been associated with fatal fulminant pancreatitis; dietary modifications, reduction in dose, or drug therapy should be employed to control significant elevations of triglycerides; despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of therapy should be considered
• Triglyceride increases sufficient to be associated with pancreatitis not common; however, fatal fulminant pancreatitis; there have been rare reports of pancreatitis during therapy in the absence of hypertriglyceridemia

Pregnancy & Lactation

• May cause severe birth defects; female patients must not be pregnant when therapy is initiated; they must not become pregnant while taking this drug and for at least 3 years after stopping therapy, so that the drug can be eliminated to below a blood concentration that would be associated with an increased incidence of birth defects; because this threshold has not been established for this drug in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely.
• Major human fetal abnormalities have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of bones (hip, ankle, forearm, skull, cerebral vertebrae), low-set ears, high palate, decreased cranial volume, and cardiovascular malformations

Lactation

• Studies on lactating rats have shown that retinoids are excreted in the milk; there is one prospective case report where acitretin is reported to be excreted in human milk; nursing mothers should not receive the drug before or during nursing because of the potential for serious adverse reactions in nursing infants