🇺🇸 PHENIRAMINE MALEATE in United States

FDA authorised PHENIRAMINE MALEATE on 27 September 2010 · 317 US adverse-event reports

Marketing authorisations

FDA — authorised 27 September 2010

  • Application: ANDA078208
  • Marketing authorisation holder: ALTAIRE PHARMS INC
  • Status: approved

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 — 38 reports (11.99%)
  2. Pain — 36 reports (11.36%)
  3. Fatigue — 34 reports (10.73%)
  4. Headache — 33 reports (10.41%)
  5. Pyrexia — 33 reports (10.41%)
  6. Thrombocytopenia — 32 reports (10.09%)
  7. Drug Ineffective — 29 reports (9.15%)
  8. Back Pain — 28 reports (8.83%)
  9. Constipation — 27 reports (8.52%)
  10. Hypertension — 27 reports (8.52%)

Source database →

PHENIRAMINE MALEATE 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 PHENIRAMINE MALEATE approved in United States?

Yes. FDA authorised it on 27 September 2010; FDA has authorised it.

Who is the marketing authorisation holder for PHENIRAMINE MALEATE in United States?

ALTAIRE PHARMS INC holds the US marketing authorisation.