🇺🇸 ORPHENADRINE HYDROCHLORIDE in United States

FDA authorised ORPHENADRINE HYDROCHLORIDE on 10 May 1957 · 67 US adverse-event reports

Marketing authorisations

FDA — authorised 10 May 1957

  • Application: NDA010653
  • Marketing authorisation holder: 3M
  • Local brand name: DISIPAL
  • Indication: TABLET — ORAL
  • Status: approved

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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 — 9 reports (13.43%)
  2. Back Pain — 8 reports (11.94%)
  3. Arthralgia — 7 reports (10.45%)
  4. Condition Aggravated — 7 reports (10.45%)
  5. Asthenia — 6 reports (8.96%)
  6. C-Reactive Protein Increased — 6 reports (8.96%)
  7. Diarrhoea — 6 reports (8.96%)
  8. Drug Hypersensitivity — 6 reports (8.96%)
  9. Fatigue — 6 reports (8.96%)
  10. Pain — 6 reports (8.96%)

Source database →

Frequently asked questions

Is ORPHENADRINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 10 May 1957; FDA has authorised it.

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

3M holds the US marketing authorisation.