Skip to Content

Label Changes for:

Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets

December 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012



Clostridium Difficile Associated Diarrhea
  • Published observational studies suggest that PPI therapy like Omeprazole/Sodium Bicarbonate/ Magnesium Hydroxide Tablets may be associated with an increased risk of Clostridium difficile associated diarrhea,especially in hospitalized patients…
Interaction with Clopidogrel
  • Avoid concomitant use of Omeprazole/Sodium Bicarbonate/Magnesium/Hydroxide Tablets with Clopidogrel…
Concomitant Use of Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets with St. John’s Wort or Rifampin
  • Drugs which induce CYP2C19 OR CYP34A (such as St John’s Wort or rifampin) can substantially decrease omeprazole concentrations…
Interactions with Investigations for Neuroendocrine Tumors
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity…
Concomitant Use of Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets with Methotrexate
  • Literature suggests that concomitant use of PPIs with Methotrexate (primarily at high dose; see Methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to Methotrexate toxicities…