Safety

Zarontin (ethosuximide) capsules

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

May 2016

Summary View

WARNINGS

Serious Dermatologic Reactions
  • Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have been reported 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 the rash is clearly not drug-related. If signs or symptoms suggest SJS, use of this drug should not be resumed and alternative therapy should be considered.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi organ hypersensitivity, has occurred with ZARONTIN. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e.g. fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. ZARONTIN should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

ADVERSE REACTIONS

  • Body As A Whole: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

MEDICATION GUIDE

ZARONTIN can cause serious side effects, including:

Drug reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call your healthcare provider right away if you have any of these symptoms:

  • joint pain and swelling
  • muscle pain
  • fatigue, weakness
  • low-grade fever
  • pain in the chest that is worse with breathing
  • skin rash
  • swollen lymph glands
  • swelling of your face
  • yellowing of your skin or the white part of your eyes

 

May 2012

Summary View

WARNINGS

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

PRECAUTIONS

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

ADVERSE REACTIONS

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

 

September 2010

Summary View

MEDICATIONS GUIDE 

  • REMS consists of a comprehensive Medication Guide

 

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