Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems.
Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome.
Adverse Events/Postmarketing Reports: In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Acute myocardial infarction, thromboembolism (see WARNINGS ), stroke.
Immune System Disorders: Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS ).
Nervous System: Myopathy with peripheral neuropathy has been reported during therapy with acitretin.
Both conditions improved with discontinuation of the drug.
Psychiatric: Aggressive feelings and/or suicidal thoughts have been reported.
These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking acitretin.
WARNINGS ( See also boxed CONTRAINDICATIONS AND WARNINGS .) Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin.
Liver function test results in these subjects returned to normal after acitretin was discontinued.
Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis.
A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis.
One subject in a Canadian clinical trial of 63 subjects developed a 3-fold increase of transaminases.
Like all medications, Acitretin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: