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Oxytocin
Oxytocin is FDA-approved as a hospital shot for labor and for bleeding after birth. The evidence grade is moderate-human for that use. No nasal spray is on the market as an approved drug, and a large trial of a spray in children with autism found no benefit.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Pitocin | primary | dailymed.nlm.nih.gov | |
| Class | other | primary | dailymed.nlm.nih.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-26 | primary | accessdata.fda.gov | |
| Evidence grade | moderate-human | our assessment | peptideindex.ai | |
| Label dosing | From the Pitocin label. To start or strengthen labor, it is given only by drip into a vein, in a hospital, under close watch. It starts at 0.5 to 1 milliunit a minute. The rate rises by 1 to 2 milliunits a minute every 30 to 60 minutes until the contractions are right. To control bleeding after birth, 10 to 40 units go into a running drip, or 10 units are given as a shot into a muscle after the placenta comes out. The prescriber sets the dose. | primary | dailymed.nlm.nih.gov |
Short answer
Oxytocin is FDA-approved as a hospital shot for labor and for bleeding after birth. The evidence grade is moderate-human for that use. No nasal spray is on the market as an approved drug, and a large trial of a spray in children with autism found no benefit.
Our assessment, drawn from the sources below.
What it is
Oxytocin is a hormone the body makes. It is a small peptide, a chain of nine amino acids [3] [18]. It makes the womb contract, which is why it is used in labor [3]. It is close in shape to vasopressin, a hormone that makes the body hold water [3].
The approved drug is made in a lab. In a hospital, it is given by drip into a vein or as a shot into a muscle [3] [4]. The body clears it within minutes [3].
Researchers also test oxytocin as a nasal spray, because it plays a part in emotions and social behavior [18]. No nasal spray is sold as an approved drug in the US today [5].
Where it stands legally
Oxytocin is FDA-approved: Drugs@FDA lists Pitocin and a second oxytocin shot as approved prescription drugs [1] [2]. That approval covers a shot given in a hospital for labor and for bleeding after birth. It does not cover nasal sprays, or any use for mood, autism or relationships [3] [4]. Checked 26 October 2026.
The labels say oxytocin is not for elective induction, which means starting labor with no medical reason [3] [4]. The only nasal spray FDA approved, Syntocinon, is listed as discontinued [5]. So no approved nasal spray is on the market today.
Pharmacies may compound with raw oxytocin, because it is part of FDA-approved drugs [6] [8]. FDA's list for outsourcing facilities names oxytocin among raw substances under review, and marks it as part of approved drugs [8]. It is not on FDA's 503A category list of nominated raw substances [7]. FDA's 503A bulks list is for raw substances that are not part of an approved drug [6]. Compounded drugs are not FDA-approved. FDA has not reviewed them before sale [9]. A pharmacy may not regularly make copies of a drug that is on the market [9].
What the evidence shows
Evidence grade: moderate-human · our assessment
The evidence grade is moderate-human: many trials in women giving birth use oxytocin as the standard drug to prevent heavy bleeding [12]. A 2018 Cochrane review pooled 140 trials with 88,947 women [12]. It found three other options prevented more heavy bleeding than oxytocin alone. About 10.5% of women given oxytocin had heavy bleeding, against 7.2% given oxytocin with ergometrine [12]. Most trials were hard to judge because they were poorly reported [12].
Nasal oxytocin is a different story. In a 24-week trial of 290 children and teens with autism, the spray did no better than a dummy spray on social skills [13] [21]. A 2026 review of 42 trials in mental disorders found no clear benefit overall [14]. It saw a small effect in schizophrenia, which needs more study [14].
Much of the social story comes from animal work. In mice, oxytocin in one brain area was needed to recognize other mice [17]. That does not show a spray changes how people feel or act.
Known risks
- Too much oxytocin can make the womb contract too hard or too long. That can tear the womb and starve the baby of oxygen [3].
- Oxytocin makes the body hold water. Long drips have caused water poisoning with seizures and coma, and deaths have been reported [3] [4]. A 2021 case report described it during labor, with brain symptoms and very low blood salt [16].
- Some mothers given oxytocin drips in labor have died. The causes were very high blood pressure, bleeding in the brain or a torn womb [3].
- In babies, the label lists a slow heart rate, jaundice, bleeding in the eye, seizures, brain damage and death [3].
- Some oxytocin made by compounders was recalled. Some bags were too weak, and one batch was mixed wrong [10] [11].
- In five trials of nasal oxytocin in autism, nose discomfort, tiredness and irritability were the most common problems. They were not tied to the spray more than to a dummy spray [15].
What nobody knows yet
- Nobody knows if a nasal spray helps social skills in autism. The largest trial, of 290 children and teens, found no benefit over a dummy spray [13].
- A 2026 review of 42 trials found no clear benefit in mental disorders overall. A small signal in schizophrenia is not settled [14].
- The long-term risks of daily nasal use are unclear. The 2018 review of unwanted effects pooled only five small trials [15].
- No study has checked if oxytocin causes cancer. No study has checked how it affects fertility either [3].
- Mouse studies tie oxytocin to social memory. They do not show that a spray changes how people feel or act [17].
Legitimate ways to get it
The legal way to get oxytocin is as a prescription drug given in a hospital. Pitocin and a second approved oxytocin shot are made for labor and for bleeding after birth [1] [2] [3] [4].
Pharmacies may compound oxytocin from raw powder, because it is part of approved drugs [6] [8]. A compounded product is not FDA-approved [9]. A pharmacy may not regularly make copies of a drug that is on the market [9].
Nasal oxytocin is being tested in trials. Recruiting US studies include veterans with PTSD and their partners, children with autism, and women caring for a family member with dementia [18] [19] [20]. The trials block on this page lists open trials with their dates.
Approved product
Approved by FDA and given with a prescription in a hospital, by drip into a vein or as a shot into a muscle.
Brand names: Pitocin
Manufacturer: Par Health USA
Indication: Starting or strengthening labor when there is a medical reason, helping empty the womb after an incomplete abortion, and controlling bleeding after birth.
Lawful compounding
Pharmacies may compound with raw oxytocin because it is part of FDA-approved drugs. A compounded product is not FDA-approved.
Clinical trial
Trials of nasal oxytocin are recruiting in the US, for example in veterans with PTSD and their partners. The trials block lists open trials.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07730294
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Phase: Phase 2 · Sponsor: Yale University · Status: Not yet recruiting
Countries: United States
US states: Connecticut
NCT07815496
The Effects of Oxytocin on Fairness Perception and Related Prosocial Behaviors
Phase: Not applicable · Sponsor: University of Electronic Science and Technology of China · Status: Recruiting
Countries: China
US states: none listed
NCT06364228
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Phase: Phase 2 · Sponsor: University of Nebraska · Status: Recruiting
Countries: United States
US states: Nebraska
NCT07559656
Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity
Phase: Not applicable · Sponsor: University of Electronic Science and Technology of China · Status: Recruiting
Countries: China
US states: none listed
NCT07425938
Oxytocin's Effects on Emotional Processing and Its Acting Routes
Phase: Not applicable · Sponsor: University of Electronic Science and Technology of China · Status: Recruiting
Countries: China
US states: none listed
NCT07367672
The Power of Belief: Expectation-driven and Placebo Modulation of Empathic Pain
Phase: Not applicable · Sponsor: University of Electronic Science and Technology of China · Status: Recruiting
Countries: China
US states: none listed
NCT07162584
Oxytocin and Human Defensive Responses in a Dynamic Situation
Phase: Not applicable · Sponsor: University of Electronic Science and Technology of China · Status: Recruiting
Countries: China
US states: none listed
NCT04789148
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Phase: Phase 1 · Sponsor: Elizabeth Austen Lawson · Status: Recruiting
Countries: United States
US states: Massachusetts
NCT07265180
Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
Phase: Not applicable · Sponsor: Charite University, Berlin, Germany · Status: Recruiting
Countries: Germany
US states: none listed
NCT06808516
Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Phase: Phase 2 · Sponsor: University Hospital, Basel, Switzerland · Status: Recruiting
Countries: Switzerland
US states: none listed
NCT06676774
Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus and Healthy Controls
Phase: Phase 2 · Sponsor: University Hospital, Basel, Switzerland · Status: Recruiting
Countries: Switzerland
US states: none listed
NCT06194851
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Phase: Phase 2 · Sponsor: VA Office of Research and Development · Status: Recruiting
Countries: United States
US states: California
NCT06222749
Oxytocin and Reward Processing in Women
Phase: Not applicable · Sponsor: International Research Training Group 2804 · Status: Recruiting
Countries: Germany
US states: none listed
NCT06248710
Dog Presence and Oxytocin on Trust Towards Therapists
Phase: Phase 2/Phase 3 · Sponsor: Dr. Karin Hediger · Status: Recruiting
Countries: Switzerland
US states: none listed
NCT07551882
Oxytocin Plus Self-compassion Training in Borderline Personality Disorder
Phase: Phase 2 · Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Status: Recruiting
Countries: Spain
US states: none listed
NCT06036004
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Phase: Phase 2 · Sponsor: University Hospital, Basel, Switzerland · Status: Recruiting
Countries: Germany, Netherlands, Switzerland
US states: none listed
NCT05761860
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Phase: Early phase 1 · Sponsor: University of Florida · Status: Recruiting
Countries: United States
US states: Florida
NCT05754073
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Phase: Phase 2 · Sponsor: Elizabeth Austen Lawson · Status: Recruiting
Countries: United States
US states: Massachusetts, Virginia
NCT05864508
Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.
Phase: Phase 2 · Sponsor: University Hospital, Toulouse · Status: Not yet recruiting
Countries: France
US states: none listed
NCT05664516
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
Phase: Phase 2 · Sponsor: Massachusetts General Hospital · Status: Recruiting
Countries: United States
US states: Massachusetts
NCT04218409
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
Phase: Early phase 1 · Sponsor: University of Florida · Status: Recruiting
Countries: United States
US states: Florida
NCT03860233
Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine
Phase: Phase 1 · Sponsor: Vivek Jain · Status: Recruiting
Countries: United States
US states: District of Columbia
How people are getting it anyway
This section describes what happens and is not a recommendation.
Oxytocin reaches some patients as products mixed by compounders rather than as approved vials [10] [11]. These include ready-to-use drip bags made for hospitals [10]. In 2017, a compounder recalled such bags after tests found them weaker than expected. A weak bag could delay care in labor [10]. In January 2024, FDA warned an outsourcing facility about mold and poor clean-room practice. It had recalled a batch of oxytocin with the wrong formula [11]. Compounded drugs are not FDA-approved, and FDA does not review them before sale [9].
No FDA page we found describes nasal oxytocin sold straight to consumers. So this page does not describe that channel.
Compounding outside the rules
Oxytocin mixed by compounders, such as ready-to-use drip bags sold to hospitals.
The lawOutsourcing facilities must follow factory quality rules. A drug made in unclean conditions is adulterated, and shipping it breaks federal law.fda.gov
Documented riskIn 2017, a compounder recalled oxytocin drip bags made for hospitals after tests found them weaker than expected.fda.gov
Documented riskFDA inspectors found mold on glove samples and poor clean-room practice at an outsourcing facility that had recalled an oxytocin batch with the wrong formula.fda.gov
Enforcement FDA warning letter to an outsourcing facility for unclean conditions and quality failures. The letter notes its recall of an oxytocin batch with the wrong formula.fda.gov
Sources
- [1]Drugs@FDA: Pitocin injection, application 018261Regulatory · primary
- [2]Drugs@FDA: oxytocin injection, application 018248Regulatory · primary
- [3]DailyMed: Pitocin (oxytocin injection) label, updated May 2026Label · primary
- [4]DailyMed: oxytocin injection label, revised July 2023Label · primary
- [5]Drugs@FDA: Syntocinon nasal solution, application 012285, discontinuedRegulatory · primary
- [6]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [7]FDA: 503A bulk drug substances category list, updated May 2026Regulatory · primary
- [8]FDA: 503B bulk drug substances category list, updated March 2025Regulatory · primary
- [9]FDA guidance: compounded drugs that are essentially copies, January 2018Regulatory · primary
- [10]FDA-posted recall notice: compounded oxytocin drip bags weaker than labeled, 2017Regulatory · primary
- [11]FDA warning letter to an outsourcing facility that recalled an oxytocin batch, 26 January 2024Regulatory · primary
- [12]Cochrane network meta-analysis: drugs to prevent heavy bleeding after birth, 2018Systematic review · peer-reviewed
- [13]Randomized trial: nasal oxytocin in children and teens with autism, 2021Rct · peer-reviewed
- [14]Meta-analysis: nasal oxytocin trials in mental disorders, 2026Systematic review · peer-reviewed
- [15]Review: unwanted effects of long-term nasal oxytocin in autism, 2018Systematic review · peer-reviewed
- [16]Case report: water intoxication during labor stimulated with oxytocin, 2021Reference · peer-reviewed
- [17]Mouse study: oxytocin in the medial amygdala and social recognition, 2001Animal · peer-reviewed
- [18]ClinicalTrials.gov NCT06194851: nasal oxytocin with couples therapy for veterans with PTSDReference · primary
- [19]ClinicalTrials.gov NCT05754073: nasal oxytocin and bone health in children with autismReference · primary
- [20]ClinicalTrials.gov NCT06364228: nasal oxytocin for caregivers of persons with dementiaReference · primary
- [21]Healio: oxytocin does not improve social functioning in children with autism, 2021Reference · established-news
Last verified · 6 facts · 7 sources
- clinicaltrials.gov
- dailymed.nlm.nih.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- accessdata.fda.gov
- fda.gov
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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