Safety

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg

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

December 2014

Summary View

CONTRAINDICATIONS

  • … contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria

WARNINGS AND PRECAUTIONS

Acute Interstitial Nephritis

*Section Added

Cyanocobalamin (vitamin B12) Deficiency

*Section added

DRUG INTERACTIONS

*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil

 

January 2012

Summary View

5 WARNINGS AND PRECAUTIONS

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

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • microsopic colitis....added

7 DRUG INTERACTIONS

7.7 Methotrexate
  • Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate.....

MEDICATION GUIDE

Tell your healthcare provider about all the medicines you take.....

Especially tell your healthcare provider if you take:

  • Erlotinib ....added

 

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