FDA — authorised 19 November 1980
- Application: NDA018261
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
🇺🇸 pitocin in United States
FDA authorised pitocin on 19 November 1980 · 429 US adverse-event reports
Marketing authorisations
FDA — authorised 24 January 2008
- Application: ANDA077453
- Marketing authorisation holder: DR REDDYS
- Local brand name: OXYTOCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA200219
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: OXYTOCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 429
Most-reported reactions
- Postpartum Haemorrhage — 58 reports (13.52%)
- Exposure During Pregnancy — 54 reports (12.59%)
- Drug Ineffective — 52 reports (12.12%)
- Drug Exposure During Pregnancy — 47 reports (10.96%)
- Foetal Exposure During Pregnancy — 44 reports (10.26%)
- Maternal Exposure During Pregnancy — 44 reports (10.26%)
- Hypotension — 39 reports (9.09%)
- Caesarean Section — 35 reports (8.16%)
- Pain — 29 reports (6.76%)
- Off Label Use — 27 reports (6.29%)
pitocin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is pitocin approved in United States?
Yes. FDA authorised it on 19 November 1980; FDA authorised it on 24 January 2008; FDA authorised it on 13 February 2013.
Who is the marketing authorisation holder for pitocin in United States?
PH HEALTH holds the US marketing authorisation.