🇺🇸 MORICIZINE HYDROCHLORIDE in United States

FDA authorised MORICIZINE HYDROCHLORIDE on 19 June 1990 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 19 June 1990

  • Application: NDA019753
  • Marketing authorisation holder: SHIRE
  • Local brand name: ETHMOZINE
  • Indication: TABLET — ORAL
  • 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. Atrial Fibrillation — 1 report (10%)
  2. Cardiac Failure — 1 report (10%)
  3. Cough — 1 report (10%)
  4. Dry Mouth — 1 report (10%)
  5. Dry Throat — 1 report (10%)
  6. Oropharyngeal Discomfort — 1 report (10%)
  7. Stress Urinary Incontinence — 1 report (10%)
  8. Supraventricular Extrasystoles — 1 report (10%)
  9. Underdose — 1 report (10%)
  10. Ventricular Extrasystoles — 1 report (10%)

Source database →

MORICIZINE 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 MORICIZINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 19 June 1990; FDA has authorised it.

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

SHIRE holds the US marketing authorisation.