🇺🇸 PENTAZOCINE in United States

FDA authorised PENTAZOCINE on 21 January 1997 · 2,342 US adverse-event reports

Marketing authorisations

FDA — authorised 21 January 1997

  • Application: ANDA074736
  • Marketing authorisation holder: WATSON LABS
  • Indication: Labeling
  • Status: approved

The FDA approved PENTAZOCINE for marketing by WATSON LABS on 22 December 2025. The approval was granted under the standard expedited pathway. The application number for this approval is ANDA074736. The approved indication for PENTAZOCINE is listed in the labelling.

Read official source →

FDA — authorised 17 March 2000

  • Application: ANDA075523
  • Marketing authorisation holder: SUN PHARM INDS LTD
  • Indication: Labeling
  • Status: approved

Read official source →

FDA — authorised 11 July 2001

  • Application: ANDA075735
  • Marketing authorisation holder: LUPIN
  • Indication: Labeling
  • Status: approved

Read official source →

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. Diarrhoea — 246 reports (10.5%)
  2. Tachycardia — 237 reports (10.12%)
  3. Arthralgia — 236 reports (10.08%)
  4. Dizziness — 235 reports (10.03%)
  5. Fall — 235 reports (10.03%)
  6. Insomnia — 232 reports (9.91%)
  7. Sepsis — 232 reports (9.91%)
  8. Dyspnoea — 230 reports (9.82%)
  9. Nausea — 230 reports (9.82%)
  10. Pruritus — 229 reports (9.78%)

Source database →

PENTAZOCINE 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 approved in United States?

Yes. FDA authorised it on 21 January 1997; FDA authorised it on 17 March 2000; FDA authorised it on 11 July 2001.

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

WATSON LABS holds the US marketing authorisation.