Safety

Aciphex (rabeprazole sodium) Delayed-Release Tablets

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

December 2014

Summary View

CONTRAINDICATIONS

  • … is contraindicated in patients with known hypersensitivity to rabeprazole, 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
 

 

October 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • The pregnancy category has also been changed from a B to a C.

 

May 2012

Summary View

5 WARNINGS AND PRECAUTIONS

5.8 Concomitant use of ACIPHEX with Methotrexate
  • New section 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 and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted. [see Warnings and Precautions (5.8)].

 

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