Sexual & reproductive Oxytocin receptor agonist
Oxytocin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Oxytocin (sold as Pitocin) is a nine-amino-acid pituitary hormone that makes the uterus contract, used to start or strengthen labor and to control bleeding after delivery. It was the first peptide hormone to be chemically synthesized, work that earned a Nobel Prize, and it remains a mainstay of obstetric care. Synthetic oxytocin has been in U.S. clinical use for decades and is given by controlled intravenous infusion for labor.
At a glance
- What it is
- A nonapeptide hormone (uterotonic) that stimulates uterine contractions
- Approved for
- Medically indicated induction or augmentation of labor, and control of postpartum bleeding
- Key fact
- Across trials, higher-dose infusion raises the risk of excessive uterine contraction without clearly shortening labor
- Route
- Intravenous infusion for labor; intramuscular for postpartum bleeding
- Evidence strength
- FDA approved
Summary
Oxytocin is a nine-amino-acid pituitary hormone. Learn how it makes the uterus contract, why it is FDA-approved for labor, and its side effects.
What is oxytocin?
Oxytocin, sold under the brand Pitocin, is a synthetic copy of a nine-amino-acid hormone made in the hypothalamus and released by the posterior pituitary. In the body it drives uterine contractions during labor and the "let-down" of milk during breastfeeding. The pharmaceutical form is used chiefly in obstetrics to influence the timing and strength of labor and to reduce bleeding after birth.
The history of oxytocin
Oxytocin has a notable place in the history of biochemistry. In 1953 the chemist Vincent du Vigneaud determined its structure and synthesized it, making oxytocin the first polypeptide hormone to be chemically made in the laboratory. That achievement earned him the 1955 Nobel Prize in Chemistry and opened the door to synthetic peptide drugs more broadly. Synthetic oxytocin replaced earlier pituitary extracts and has been a standard obstetric medication ever since.
How does oxytocin work?
Oxytocin binds oxytocin receptors on uterine smooth muscle, raising intracellular calcium and increasing the force and frequency of contractions. The uterus becomes markedly more sensitive to oxytocin as pregnancy reaches term, which is why carefully titrated doses can establish an effective labor pattern. Oxytocin also acts on the myoepithelial cells around the mammary glands to produce milk let-down.
Because the dose-response is steep and varies between women, oxytocin for labor is given as a dilute intravenous infusion that is titrated slowly against the contraction pattern and the baby's heart rate. Comparative trials show that higher-dose regimens increase the chance of uterine hyperstimulation without clearly shortening labor, so monitoring is essential. For postpartum bleeding, oxytocin causes the emptied uterus to clamp down, reducing blood loss.
Is it FDA-approved?
Editor’s note
Status: Yes. Synthetic oxytocin (Pitocin) is approved by the FDA and has been a standard obstetric drug for decades. Its label carries a boxed warning that it is not indicated for elective induction of labor, meaning induction with no medical reason, because the available data are inadequate to weigh the benefits against the risks.
Category: FDA-approved · Primary body area: Sexual & reproductive
Yes. Synthetic oxytocin (Pitocin) is approved by the FDA and has been a standard obstetric drug for decades. Its label carries a boxed warning that it is not indicated for elective induction of labor, meaning induction with no medical reason, because the available data are inadequate to weigh the benefits against the risks.
What is oxytocin prescribed for?
Oxytocin is used:
- To initiate or improve uterine contractions when there is a medical reason to induce or augment labor
- To help manage incomplete or inevitable abortion
- After delivery, to control uterine bleeding and atony
It is administered by clinicians in a monitored setting.
What are the side effects?
Common and dose-related effects include:
- Nausea
- Faster or stronger uterine contractions
- Transient changes in maternal blood pressure or heart rate
More serious considerations include:
- Uterine hyperstimulation or tetanic contractions, which can cause fetal distress or, rarely, uterine rupture
- Water intoxication and low blood sodium with prolonged high-dose infusion, because oxytocin has a mild antidiuretic effect
Sources: FDA prescribing information for Pitocin; a Cochrane review of oxytocin dosing for induction (Budden et al., Cochrane Database of Systematic Reviews, 2014, DOI: 10.1002/14651858.CD009701.pub2), indexed on PubMed; historical accounts of du Vigneaud's synthesis of oxytocin. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
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