🇺🇸 Pepcid in United States

FDA authorised Pepcid on 28 April 1995 · 26,158 US adverse-event reports

Marketing authorisations

FDA — authorised 28 April 1995

  • Application: NDA020325
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: supplemented

FDA — authorised 16 October 2000

  • Application: NDA020958
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: approved

FDA — authorised 16 April 2001

  • Application: ANDA075805
  • Marketing authorisation holder: CARLSBAD
  • Status: supplemented

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 — 4,613 reports (17.64%)
  2. Nausea — 2,923 reports (11.17%)
  3. Fatigue — 2,785 reports (10.65%)
  4. Acute Kidney Injury — 2,761 reports (10.56%)
  5. Renal Failure — 2,600 reports (9.94%)
  6. Diarrhoea — 2,356 reports (9.01%)
  7. Drug Ineffective — 2,187 reports (8.36%)
  8. Dyspnoea — 2,041 reports (7.8%)
  9. Headache — 2,018 reports (7.71%)
  10. Pain — 1,874 reports (7.16%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Pepcid approved in United States?

Yes. FDA authorised it on 28 April 1995; FDA authorised it on 16 October 2000; FDA authorised it on 16 April 2001.

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

KENVUE BRANDS holds the US marketing authorisation.