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Label Changes for:

Zarontin (ethosuximide) Capsules

May 2012

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

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


May 2012


Serious Dermatologic Reactions
  • Serious dermatologic reactions, including with ethosuximide treatment. SJS can be fatal. The onset of symptoms is usually within 28 days, but can occur later. Zarontin should be discontinued at the first sign of a rash, unless symptoms suggest SJS, use of this drug should considered


Information for Patients
  • Prior to initiation of treatment with Zarontin, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately


Body as a Whole
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).



September 2010



  • REMS consists of a comprehensive Medication Guide