🇺🇸 Diphenhydramine 25mg in United States

147 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. Infusion Related Reaction — 40 reports (27.21%)
  2. Dyspnoea — 17 reports (11.56%)
  3. Nausea — 17 reports (11.56%)
  4. Pruritus — 15 reports (10.2%)
  5. Headache — 13 reports (8.84%)
  6. Urticaria — 12 reports (8.16%)
  7. Flushing — 10 reports (6.8%)
  8. Rash — 8 reports (5.44%)
  9. Vomiting — 8 reports (5.44%)
  10. Diarrhoea — 7 reports (4.76%)

Source database →

Diphenhydramine 25mg 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 Diphenhydramine 25mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Diphenhydramine 25mg in United States?

Montefiore Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.