Brand Names: Soriatane

Generic Name: acitretin (Pronunciation: A si TRE tin)

• What is acitretin (Soriatane)?
• What are the possible side effects of acitretin (Soriatane)?
• What is the most important information I should know about acitretin (Soriatane)?
• What should I discuss with my healthcare provider before taking acitretin (Soriatane)?
• How should I take acitretin (Soriatane)?
• What happens if I miss a dose (Soriatane)?
• What happens if I overdose (Soriatane)?
• What should I avoid while taking acitretin (Soriatane)?
• What other drugs will affect acitretin (Soriatane)?
• Where can I get more information?

What is acitretin (Soriatane)?

Acitretin is a retinoid, which is a form of vitamin A.

Acitretin is used to treat severe psoriasis in adults. It is usually given after other psoriasis medicines have been tried without successful treatment of symptoms.

Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication.

Acitretin may also be used for other purposes not listed in this medication guide.

Soriatane 10 mg

brown/white, imprinted with SORIATANE 10 mg

Soriatane 25 mg

brown/yellow, imprinted with SORIATANE 25 mg

What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acitretin and call your doctor at once if you have any of these serious side effects:

• blurred vision, headache or pain behind your eyes, sometimes with vomiting;
• sudden decrease in night vision;
• depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
• chest pain or heavy feeling, spreading to the arm or shoulder, sweating, shortness of breath;
• sudden headache, confusion, problems with speech or balance, numbness or weakness (especially on one side of the body);
• sudden cough, wheezing, rapid breathing, fast heart rate;
• pain or swelling in one or both legs;
• jaundice (yellowing of the skin or eyes); or
• loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones.

Less serious side effects may include:

• dry or irritated eyes, thinning eyebrows or lashes;
• chapped or peeling skin, hair loss;
• dry mouth, dry or runny nose, nosebleeds;
• warmth, redness, or tingly feeling under your skin;
• nausea, diarrhea, stomach pain, loss of appetite;
• mouth sores, swollen or bleeding gums;
• headache;
• sleep problems (insomnia); or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acitretin (Soriatane)?

This medication can cause birth defects. Do not use if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. You must use 2 forms of birth control together starting at least 1 month before treatment with acitretin, and for at least 3 years after you stop taking this medication.

For women taking acitretin: Before and during treatment, and for 3 years after treatment, you must have negative pregnancy tests at regular intervals to make sure you are not pregnant. No testing is needed if you have had a hysterectomy or have gone completely through menopause.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). acitretin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Acitretin is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.