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U.S. Department of Health and Human Services

Safety

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Protonix (pantoprazole sodium) for injection

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

 

December 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • agranulocytosis, pancytopenia and taste disorders (ageusia, dyseusia)

 

 

May 2012

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.9 Concomitant use of Protonix with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong...

DRUG INTERACTIONS

7.6 Methotrexate
  • Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant.....

 

December 2011 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience:
  • weight changes
  • hyponatremia
  • asthenia
  • fatigue and malaise
  • insomnia and somnolence

 

Drug Interactions
  • clopidogrel

Pharmacokinetics

  • information about the drug-drug interaction between pantoprazole and clopidogrel