🇺🇸 PENTAZOCINE HYDROCHLORIDE in United States

FDA authorised PENTAZOCINE HYDROCHLORIDE on 3 February 1969 · 244 US adverse-event reports

Marketing authorisations

FDA — authorised 3 February 1969

  • Application: NDA016732
  • Marketing authorisation holder: SANOFI AVENTIS US
  • Local brand name: TALWIN 50
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 11 July 2001

  • Application: ANDA075735
  • Marketing authorisation holder: LUPIN
  • Status: supplemented

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. Arthralgia — 26 reports (10.66%)
  2. Dizziness — 26 reports (10.66%)
  3. Drug Interaction — 26 reports (10.66%)
  4. Fall — 25 reports (10.25%)
  5. Pyrexia — 25 reports (10.25%)
  6. Dyspnoea — 24 reports (9.84%)
  7. Headache — 24 reports (9.84%)
  8. Asthenia — 23 reports (9.43%)
  9. Nausea — 23 reports (9.43%)
  10. Abdominal Pain — 22 reports (9.02%)

Source database →

PENTAZOCINE 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 PENTAZOCINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 3 February 1969; FDA authorised it on 11 July 2001; FDA has authorised it.

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

SANOFI AVENTIS US holds the US marketing authorisation.