🇺🇸 Delayed-release omeprazole in United States

88 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Off Label Use — 13 reports (14.77%)
  2. Nausea — 12 reports (13.64%)
  3. Surgery — 12 reports (13.64%)
  4. Anxiety — 8 reports (9.09%)
  5. Drug Ineffective — 8 reports (9.09%)
  6. Fatigue — 8 reports (9.09%)
  7. Product Dose Omission Issue — 8 reports (9.09%)
  8. Product Administration Interrupted — 7 reports (7.95%)
  9. Diarrhoea — 6 reports (6.82%)
  10. Dizziness — 6 reports (6.82%)

Source database →

Delayed-release omeprazole in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Delayed-release omeprazole approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Delayed-release omeprazole in United States?

University of Louisville is the originator. The local marketing authorisation holder may differ — check the official source linked above.