🇺🇸 antihistamine in United States

FDA authorised antihistamine on 25 June 2004 · 468 US adverse-event reports

Marketing authorisations

FDA — authorised 25 June 2004

  • Application: ANDA076301
  • Marketing authorisation holder: PERRIGO
  • 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. Drug Ineffective — 64 reports (13.68%)
  2. Dyspnoea — 55 reports (11.75%)
  3. Completed Suicide — 53 reports (11.32%)
  4. Pruritus — 51 reports (10.9%)
  5. Rash — 48 reports (10.26%)
  6. Dizziness — 46 reports (9.83%)
  7. Fatigue — 40 reports (8.55%)
  8. Diarrhoea — 37 reports (7.91%)
  9. Headache — 37 reports (7.91%)
  10. Urticaria — 37 reports (7.91%)

Source database →

antihistamine 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 antihistamine approved in United States?

Yes. FDA authorised it on 25 June 2004; FDA has authorised it.

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

PERRIGO holds the US marketing authorisation.