Peptide dossier, updated Nov 2, 2026
Oxytocin
Oxytocin, a nine-amino-acid hormone. Injection brand name Pitocin. A natural hormone, made in the brain, that triggers uterine contractions and milk release. FDA-approved oxytocin injections have been on the market since 1980 for use in labor and after delivery. Oxytocin nasal sprays sold online are a separate matter that this page covers only to say what we did and did not find. This page lays out what each source actually says.
See all 8 verified records for Oxytocin on the Records page
In plain terms
Approved for: Injection only. Initiation or improvement of uterine contractions for patients with a medical reason for delivery, an adjunct in incomplete or inevitable abortion, and control of postpartum bleeding (Pitocin label). The label says it is not indicated for elective induction of labor.
What it is: A hormone made in the brain that causes the uterus to contract and the breast to release milk. The drug is a lab-made copy.
What it is said to do, and by whom:
- FDA, through the Pitocin label: approved for medical induction or augmentation of labor with continuous observation by trained staff, for intravenous use in a hospital; it lists uterine rupture, postpartum hemorrhage and a fatal clotting disorder among reported reactions.
- Researchers, 2025: an 8-week randomized trial in 61 adults with obesity tested intranasal oxytocin 24 IU four times daily to see its effect on a water-balance hormone; it was a safety-focused analysis, not a weight-loss result.
- We did not collect sellers’ claims for nasal or injectable oxytocin sold outside prescription channels.
How strong the evidence is: Strong for the approved obstetric use, which has decades of use. For intranasal oxytocin in autism, obesity and other conditions, trial results are mixed, per a 2024 review. No nasal oxytocin product has FDA approval, as far as we found.
FDA approvals and label
The approval dates are from Drugs@FDA through the openFDA API. Label content is paraphrased from the DailyMed Pitocin label (posted May 2026); we read the full text. The label governs.
| Product | Application | Original approval | Notes |
|---|---|---|---|
| Oxytocin injection (Fresenius Kabi) | Drugs@FDA NDA018248 | Jul 9, 1980 | Prescription. Marketing status per openFDA. |
| Pitocin (Par Health) | Drugs@FDA NDA018261 | Nov 19, 1980 | Prescription. Several Pitocin labels are posted on DailyMed; we read one. DailyMed label |
| Oxytocin injection (Hikma) | Drugs@FDA ANDA200219 | Feb 13, 2013 | Generic. Prescription. |
What the label says
We read the full Pitocin label on DailyMed (posted May 21, 2026).
In the label’s own words, paraphrased
- Not indicated for elective induction of labor, defined as starting labor in someone with no medical indication.
- Antepartum: indicated for initiating or improving uterine contractions where desirable for fetal or maternal reasons, to achieve vaginal delivery, including induction for a medical indication. Also as adjunctive therapy in incomplete or inevitable abortion. Postpartum: to produce contractions during the third stage of labor and to control postpartum bleeding (10 units intramuscular after delivery of the placenta is one labeled route).
- Warning: for induction or augmentation of labor it should be given only intravenously, with adequate medical supervision in a hospital. Patients must be under continuous observation by trained personnel.
- Contraindications for antepartum use include significant cephalopelvic disproportion, unfavorable fetal positions, fetal distress where delivery is not imminent, a hyperactive or hypertonic uterus, and cases where vaginal delivery is contraindicated.
- Warns that maternal deaths (from hypertensive episodes, subarachnoid hemorrhage, uterine rupture) and fetal deaths have been reported with parenteral oxytocin for induction or augmentation. Fetal and neonatal reactions listed include bradycardia, low Apgar scores, neonatal jaundice and retinal hemorrhage, seizures, permanent brain damage and death.
- Dosing is individualized to uterine response, starting very low; intravenous infusion, ideally with an infusion pump, is the only acceptable parenteral method for induction or stimulation of labor.
- Reported adverse reactions in the mother include anaphylaxis, postpartum hemorrhage, uterine rupture, cardiac arrhythmia, fatal afibrinogenemia and hypertensive episodes; excessive dosage may cause uterine hypertonicity or spasm. The label also says severe water intoxication with convulsions and coma has occurred with slow infusion over 24 hours, and maternal death from oxytocin-induced water intoxication has been reported.
What we did not read
- Any FDA review document, or the other Pitocin labels. We did not compare label versions.
- Nasal oxytocin: the FDA drug database through openFDA lists only injectable oxytocin products, and its drug-label search returned no nasal oxytocin label. We did not search other countries.
Trials and published research
ClinicalTrials.gov returns 936 studies for oxytocin and PubMed returns about 34,000 results as of Nov 2, 2026. We did not review them; the two papers below are examples read by abstract.
What the papers show
- Intranasal oxytocin in obesity, 2025. 8-week randomized trial; 63 adults with obesity assessed and 61 randomized to oxytocin 24 IU four times daily or placebo. The paper measured vasopressin, a hormone that regulates water balance, around a standard meal and over treatment. Levels fell after eating and did not change significantly with oxytocin versus placebo. It is a safety-focused analysis, not a weight-loss result. J Clin Endocrinol Metab PubMed
- Autism and Prader-Willi syndrome, 2024 review. The review says clinical trials of oxytocin for core symptoms of these conditions “have shown discrepant results.” It proposes dosing as needed alongside social interventions. Pharmacol Ther PubMed
Read with care
- The approved use is the injection in obstetric care. Nothing in these papers changes that.
- We cannot summarize 34,000 papers. This page does not assess oxytocin for any use beyond the label.
- We read abstracts, not full text, funding or disclosures.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six peptides; Oxytocin is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
- July 23–24, 2026RegulatoryFDA advisory committee meets on seven peptides; Oxytocin is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Oxytocin.
- May 21, 2026LabelPitocin label posted on DailyMed
Latest of several Pitocin label versions we saw.
- Feb 13, 2013ApprovalFDA approves a generic oxytocin injection (ANDA 200219)
Hikma. Original approval per openFDA.
- Nov 19, 1980ApprovalFDA approves Pitocin (NDA 018261)
Original approval per openFDA.
- Jul 9, 1980ApprovalFDA approves oxytocin injection (NDA 018248)
Fresenius Kabi. Original approval per openFDA.
Still not covered
Left off rather than guessed:
- HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not oxytocin.
- FDA review: we found no FDA briefing document or advisory committee evaluation for oxytocin. FDA’s notice for the July meeting does not name it.
- Nasal oxytocin: openFDA lists only injectable approved products, and we found no FDA warning letter about oxytocin. FDA letters cannot be searched by peptide, so absence is not proven.
- Clinical pharmacology: we did not review it in detail.
- Trial evidence beyond obstetrics: not reviewed. 936 registered studies exist.
- Marketing status: we did not confirm which products are currently marketed.
- Patents and SEC filings: not researched for this dossier.
- Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
- Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.