From the Guidelines
Acitretin commonly causes several side effects, including dry skin, dry lips, dry eyes, hair thinning or loss, peeling skin, and nail fragility, and can also lead to more serious side effects such as elevated blood lipids, liver enzyme abnormalities, and birth defects if taken during pregnancy. The most frequent side effects of acitretin are mucocutaneous, including xerosis, dryness of the eye, nasal/oral mucosa, epistaxis, cheilitis, itching or burning skin, and brittle nails, all of which may range from mild to severe, depending on individual patient characteristics and the dose of acitretin 1. Hair loss is more common in women, especially in doses that exceed 17.5 mg per day. Other adverse effects of acitretin include hyperlipidemia, which is present in 25% to 50% of patients, and is the most common laboratory abnormality associated with acitretin use 1.
Some key points to consider when prescribing acitretin include:
- The recommended schedule is to begin with 2 weeks of acitretin monotherapy, followed by UVB phototherapy, with an initial UVB dose decrease of 30% to 50% for the first week, followed by a gradual increase, as tolerated 1.
- Acitretin is highly teratogenic, meaning it can cause severe birth defects, so women of childbearing potential must use effective contraception during treatment and for at least 3 years after stopping the medication 1.
- Regular blood tests to monitor liver function and lipid levels are necessary during treatment, with LFTs, lipid profile, CBC count, and renal function tests recommended at baseline and ongoing monitoring 1.
- Acitretin may interact with other medications, including ethanol, glibenclamide, and methotrexate, and concomitant administration of vitamin A and other oral retinoids with acitretin should be avoided 1.
Overall, the use of acitretin requires careful consideration of the potential side effects and interactions, as well as regular monitoring to minimize the risk of adverse effects.
From the FDA Drug Label
Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP), or LDH have occurred in approximately 1 in 3 subjects treated with acitretin capsules. Ten of 652 subjects treated in U. S. clinical trials of etretinate, of which acitretin is the active metabolite, had clinical or histologic hepatitis considered to be possibly or probably related to etretinate treatment. There have been reports of hepatitis-related deaths worldwide; a few of these subjects had received etretinate for a month or less before presenting with hepatic symptoms or signs In clinical trials with acitretin capsules, subjects were prospectively evaluated for evidence of development or change in bony abnormalities of the vertebral column, knees, and ankles. Blood lipid determinations should be performed before acitretin capsules are 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 In subjects receiving acitretin capsules during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. The eyes and vision of 329 subjects treated with acitretin capsules were examined by ophthalmologists. Lipid elevations occur in 25% to 50% of subjects treated with acitretin capsules. Acitretin capsules and other retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension). Capillary leak syndrome, a potential manifestation of retinoic acid syndrome, has been reported in patients receiving acitretin capsules.
Common side effects of acitretin include:
- Elevated liver enzymes (AST, ALT, GGT, LDH) in approximately 1 in 3 subjects
- Hepatitis (clinical or histologic) in 10 of 652 subjects
- Bony abnormalities (e.g. degenerative spurs, anterior bridging of spinal vertebrae) in 15% of subjects
- Lipid elevations (e.g. triglycerides, cholesterol) in 66% and 33% of subjects, respectively
- Ophthalmologic effects (e.g. dry eyes, irritation of eyes, brow and lash loss) in 23%, 9%, and 5% of subjects, respectively
- Pancreatitis (rare reports)
- Pseudotumor cerebri (benign intracranial hypertension) (rare reports)
- Capillary leak syndrome (rare reports) 2