At a glance
- Oxytocin is an FDA-approved drug, marketed as Oxytocin, Pitocin (first approval: April 29, 1980).
- PubMed lists 7,524 publications mentioning it, including 2,062 randomized controlled trials and 1,103 animal-only studies.
- ClinicalTrials.gov lists 936 registered studies testing it (129 active).
- FDA's adverse event system (FAERS) holds 3,769 reports mentioning it; 3,395 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA018245 | SYNTOCINON | Approved, discontinued | April 17, 1980 | NOVARTIS |
| NDA018243 | OXYTOCIN | Approved, marketed | April 29, 1980 | HIKMA |
| NDA018248 | OXYTOCIN | Approved, marketed | July 9, 1980 | FRESENIUS KABI USA |
| NDA018261 | PITOCIN | Approved, marketed | November 19, 1980 | PH HEALTH |
| NDA019185 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | Approved, discontinued | March 29, 1985 | ABBOTT |
| ANDA077453 | OXYTOCIN | Approved, discontinued | January 24, 2008 | DR REDDYS |
| ANDA200219 | OXYTOCIN | Approved, marketed | February 13, 2013 | HIKMA FARMACEUTICA |
| ANDA091676 | OXYTOCIN | Approved, marketed | July 13, 2018 | SAGENT PHARMS INC |
| NDA012285 | SYNTOCINON | Approved, discontinued | — | RTRX |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Prophylactic Carbetocin Versus Oxytocin and Blood Loss After Vaginal Delivery: Agent Selection and Confounding by Indication in a Retrospective Cohort Study.
- Magnesium Sulfate, Nicardipine, and Volatile Anesthetics in Severe Preeclampsia: Clinical and Mechanistic Implications for Uterine Atony and Postpartum Hemorrhage.
- Peripartum Synthetic Oxytocin Exposure and Breastfeeding Outcomes: An Integrative Review Update.
- Preoperative Intranasal Oxytocin and Probable Acute Stress Disorder After Traumatic Fracture Surgery: A Randomized Clinical Trial.
- Comparison of 25 µg Vaginal Misoprostol Versus Dinoprostone Gel for Induction of Labor in Term Prelabor Rupture of Membranes: A Retrospective Record-Based Observational Study.
- Letter to the editor regarding "Oral calcium carbonate as an adjunct to oxytocin infusion for labor induction: a randomized controlled pilot study on feasibility and acceptability".
- Oral calcium carbonate as an adjunct to oxytocin for labor induction: considerations for a definitive trial.
- Impact of opioid use disorder on oxytocin required for labor induction in term pregnancies.
- A Community Partnership Initiative in Utah to Enhance Prehospital Perinatal Care in the Prevention of Postpartum Hemorrhage.
- Carbetocin and peri-operative hemoglobin change at cesarean delivery in a setting of self-paid use: an 8-year retrospective cohort study.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 936
- Active
- 129
- With posted results
- 162
Conditions studied
Show 40 more studies
All 936 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 3,769
- Serious
- 3,395
- With death outcome
- 198
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. - Oxytocin
- GUNA-AWARENESS
- Pitocin
- Pitocin
- Pitocin
- Connection
- Connection
- Oxytocin
- E.O.L.
- Intimate
- Emotional Eating
- Oxytocin
- Oxytocin
- Pitocin
- Weight Loss Support Plus Female Balance
- Weight Loss Support Plus Female Balance
- Intimate
- Neurotransmitter Pro
- Neurotransmitter Pro
- Appetite Control
- Appetite Control
- Appetite Control
- Hunger Control
- GUNA-GERIATRICS
- Oxytocin
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.