🇺🇸 Prilosec in United States

110,497 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. Chronic Kidney Disease — 31,759 reports (28.74%)
  2. Acute Kidney Injury — 16,241 reports (14.7%)
  3. Renal Failure — 13,389 reports (12.12%)
  4. End Stage Renal Disease — 9,311 reports (8.43%)
  5. Renal Injury — 8,587 reports (7.77%)
  6. Drug Ineffective — 6,940 reports (6.28%)
  7. Nausea — 6,695 reports (6.06%)
  8. Pain — 6,384 reports (5.78%)
  9. Fatigue — 5,810 reports (5.26%)
  10. Diarrhoea — 5,381 reports (4.87%)

Source database →

Prilosec in other countries

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

Other Other approved in United States

Frequently asked questions

Is Prilosec approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Prilosec in United States?

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