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Label Changes for:

Gralise (gabapentin) Tablets, 300 mg and 600 mg

January 2012

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012



5.4 Drug Reaction with Eosinophilia and Systemic Symptoms(DRESS)/Multiorgan Hypersensitivity
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan Hypersensitivity, has been reported in patients taking antiepileptic drugs, including GRALISE. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents .....
  • It is important to note ... are present, the patient should be evaluated immediately. GRALISE should be discontinued if an alternative etiology for the signs or symptoms cannot be established