Label Changes for:

Pepcid (famotidine) tablets

March 2010

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) – March 2010 and June 2011

 

June 2011

 

PRECAUTIONS

  • Prolonged QT interval has been reported very rarely in patients with impaired renal function whose dose/dosing interval of famotidine may not have been adjusted appropriately

 

ADVERSE REACTIONS

Cardiovascular:
  • Prolonged QT interval, in patients with impaired renal function, has been reported very rarely

 

March 2010

 

ADVERSE REACTIONS

Gastrointestinal
  • hepatitis

 

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