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Label Changes for:

Isoniazid Tablets

July 2016

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

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

July 2016

CONTRAINDICATIONS (updated)

  • Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and acute liver disease of any etiology.

ADVERSE REACTIONS

Gastrointestinal Reactions
  • Addition of the following: and pancreatitis.
Hypersensitivity Reactions
  • Addition of the following: toxic epidermal necrolysis, and drug reaction with eosinophilia syndrome (DRESS).
     
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