Label Changes for:

Soriatane (acitretin) capsules

May 2014

Changes have been made to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


May 2014


  • angioedema, urticarial hypersensitivity


  • added Capillary Leak Syndrome, Exfoliative Dermatitis/Erythroderma


  • Added Immune System Disorders, Madarosis and exfoliative dermatitis, and Vascular Disorders 


February 2014


What is the most important information I should know about SORIATANE?

SORIATANE can cause serious side effects, including:

  • 2. Liver problems, including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with SORIATANE. Stop taking SORIATANE and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem:
    • yellowing of your skin or the whites of your eyes
    • nausea and vomiting
    • loss of appetite
    • dark urine