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U.S. Department of Health and Human Services

Safety

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Aciphex (rabeprazole sodium) Delayed-Release Tablets

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