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U.S. Department of Health and Human Services

Safety

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Pepcid (famotidine) tablets

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

 

February 2014

Summary View

ADVERSE REACTIONS

  • addition of rhabdomyolysis

 

June 2011

Summary View

 

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

Summary View

 

ADVERSE REACTIONS

Gastrointestinal
  • hepatitis