Safety

Protonix (pantoprazole sodium) for injection

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

December 2013

Summary View

CONTRAINDICATIONS

  • PROTONIX is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].

WARNINGS AND PRECAUTIONS

Acute Interstitial Nephritis
  • Acute interstitial nephritis has been observed in patients taking PPIs including PROTONIX I.V. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue PROTONIX I.V. if acute interstitial nephritis develops [see Contraindications (4)].

 

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

 

Page Last Updated: 01/15/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.