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Label Changes for:

Gabitril (tiagabine hydrochloride) Tablets

November 2015

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

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

November 2015


Postmarketing Reports

The following adverse reactions have been identified during postapproval use of Gabitril. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Skin and subcutaneous tissue disorders: bullous dermatitis
  • Eye disorders: vision blurred