🇺🇸 EPHEDRINE HYDROCHLORIDE in United States

FDA authorised EPHEDRINE HYDROCHLORIDE on 14 June 2021 · 227 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 2021

  • Application: NDA213536
  • Marketing authorisation holder: DR REDDYS LABS SA
  • Local brand name: REZIPRES
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

Read official source →

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. Hypotension — 53 reports (23.35%)
  2. Nausea — 22 reports (9.69%)
  3. Cardiac Arrest — 21 reports (9.25%)
  4. Electrocardiogram St Segment Depression — 21 reports (9.25%)
  5. Pyrexia — 21 reports (9.25%)
  6. Anaphylactic Reaction — 18 reports (7.93%)
  7. Anaphylactic Shock — 18 reports (7.93%)
  8. Blood Pressure Decreased — 18 reports (7.93%)
  9. Tachycardia — 18 reports (7.93%)
  10. Toxicity To Various Agents — 17 reports (7.49%)

Source database →

EPHEDRINE HYDROCHLORIDE 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 EPHEDRINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 14 June 2021; FDA has authorised it.

Who is the marketing authorisation holder for EPHEDRINE HYDROCHLORIDE in United States?

DR REDDYS LABS SA holds the US marketing authorisation.