Label Changes for:

Provigil (modafinil) Tablets

January 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)

January 2015

ADVERSE REACTIONS

  • Psychiatric disorders: psychomotor hyperactivity 

 

October 2010

WARNINGS

Psychiatric Symptoms
  • aggression

 

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