🇺🇸 Brompheniramine + pseudoephedrine in United States

FDA authorised Brompheniramine + pseudoephedrine on 14 July 2020 · 80 US adverse-event reports

Marketing authorisation

FDA — authorised 14 July 2020

  • Application: ANDA210647
  • Marketing authorisation holder: ALKEM LABS LTD
  • 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. Nausea — 14 reports (17.5%)
  2. Headache — 10 reports (12.5%)
  3. Diarrhoea — 8 reports (10%)
  4. Pain — 8 reports (10%)
  5. Covid-19 — 7 reports (8.75%)
  6. Fatigue — 7 reports (8.75%)
  7. Influenza — 7 reports (8.75%)
  8. Vomiting — 7 reports (8.75%)
  9. Pneumonia — 6 reports (7.5%)
  10. Sinusitis — 6 reports (7.5%)

Source database →

Other Allergy/Immunology approved in United States

Frequently asked questions

Is Brompheniramine + pseudoephedrine approved in United States?

Yes. FDA authorised it on 14 July 2020.

Who is the marketing authorisation holder for Brompheniramine + pseudoephedrine in United States?

ALKEM LABS LTD holds the US marketing authorisation.