{"shortAnswer":"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.","url":"https://peptideindex.ai/compound/oxytocin","status":"fda-approved","statusCheckedAt":"2026-10-26T13:36:27.774Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:36:27.817Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"66a4cbb1-65eb-4084-a811-bfac856d43b5","object":"compound","slug":"oxytocin","name":"Oxytocin","attrs":{"name":"Oxytocin","class":"other","access":[{"type":"approved-product","detail":"Approved by FDA and given with a prescription in a hospital, by drip into a vein or as a shot into a muscle.","indication":"Starting or strengthening labor when there is a medical reason, helping empty the womb after an incomplete abortion, and controlling bleeding after birth.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad","brand_names":["Pitocin"],"manufacturer":"Par Health USA"},{"type":"lawful-compounding","detail":"Pharmacies may compound with raw oxytocin because it is part of FDA-approved drugs. A compounded product is not FDA-approved.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"type":"clinical-trial","detail":"Trials of nasal oxytocin are recruiting in the US, for example in veterans with PTSD and their partners. The trials block lists open trials.","source_url":"https://clinicaltrials.gov/study/NCT06194851"}],"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.","trials":[{"nct":"NCT07730294","url":"https://clinicaltrials.gov/study/NCT07730294","phase":"Phase 2","title":"Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery","status":"not-yet-recruiting","sponsor":"Yale University","countries":["United States"],"us_states":["Connecticut"]},{"nct":"NCT07815496","url":"https://clinicaltrials.gov/study/NCT07815496","phase":"Not applicable","title":"The Effects of Oxytocin on Fairness Perception and Related Prosocial Behaviors","status":"recruiting","sponsor":"University of Electronic Science and Technology of China","countries":["China"],"us_states":[]},{"nct":"NCT06364228","url":"https://clinicaltrials.gov/study/NCT06364228","phase":"Phase 2","title":"Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia","status":"recruiting","sponsor":"University of Nebraska","countries":["United States"],"us_states":["Nebraska"]},{"nct":"NCT07559656","url":"https://clinicaltrials.gov/study/NCT07559656","phase":"Not applicable","title":"Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity","status":"recruiting","sponsor":"University of Electronic Science and Technology of China","countries":["China"],"us_states":[]},{"nct":"NCT07425938","url":"https://clinicaltrials.gov/study/NCT07425938","phase":"Not applicable","title":"Oxytocin's Effects on Emotional Processing and Its Acting Routes","status":"recruiting","sponsor":"University of Electronic Science and Technology of China","countries":["China"],"us_states":[]},{"nct":"NCT07367672","url":"https://clinicaltrials.gov/study/NCT07367672","phase":"Not applicable","title":"The Power of Belief: Expectation-driven and Placebo Modulation of Empathic Pain","status":"recruiting","sponsor":"University of Electronic Science and Technology of China","countries":["China"],"us_states":[]},{"nct":"NCT07162584","url":"https://clinicaltrials.gov/study/NCT07162584","phase":"Not applicable","title":"Oxytocin and Human Defensive Responses in a Dynamic Situation","status":"recruiting","sponsor":"University of Electronic Science and Technology of China","countries":["China"],"us_states":[]},{"nct":"NCT04789148","url":"https://clinicaltrials.gov/study/NCT04789148","phase":"Phase 1","title":"Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency","status":"recruiting","sponsor":"Elizabeth Austen Lawson","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT07265180","url":"https://clinicaltrials.gov/study/NCT07265180","phase":"Not applicable","title":"Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison","status":"recruiting","sponsor":"Charite University, Berlin, Germany","countries":["Germany"],"us_states":[]},{"nct":"NCT06808516","url":"https://clinicaltrials.gov/study/NCT06808516","phase":"Phase 2","title":"Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls","status":"recruiting","sponsor":"University Hospital, Basel, Switzerland","countries":["Switzerland"],"us_states":[]},{"nct":"NCT06676774","url":"https://clinicaltrials.gov/study/NCT06676774","phase":"Phase 2","title":"Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus and Healthy Controls","status":"recruiting","sponsor":"University Hospital, Basel, Switzerland","countries":["Switzerland"],"us_states":[]},{"nct":"NCT06194851","url":"https://clinicaltrials.gov/study/NCT06194851","phase":"Phase 2","title":"Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD","status":"recruiting","sponsor":"VA Office of Research and Development","countries":["United States"],"us_states":["California"]},{"nct":"NCT06222749","url":"https://clinicaltrials.gov/study/NCT06222749","phase":"Not applicable","title":"Oxytocin and Reward Processing in Women","status":"recruiting","sponsor":"International Research Training Group 2804","countries":["Germany"],"us_states":[]},{"nct":"NCT06248710","url":"https://clinicaltrials.gov/study/NCT06248710","phase":"Phase 2/Phase 3","title":"Dog Presence and Oxytocin on Trust Towards Therapists","status":"recruiting","sponsor":"Dr. Karin Hediger","countries":["Switzerland"],"us_states":[]},{"nct":"NCT07551882","url":"https://clinicaltrials.gov/study/NCT07551882","phase":"Phase 2","title":"Oxytocin Plus Self-compassion Training in Borderline Personality Disorder","status":"recruiting","sponsor":"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","countries":["Spain"],"us_states":[]},{"nct":"NCT06036004","url":"https://clinicaltrials.gov/study/NCT06036004","phase":"Phase 2","title":"Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus","status":"recruiting","sponsor":"University Hospital, Basel, Switzerland","countries":["Germany","Netherlands","Switzerland"],"us_states":[]},{"nct":"NCT05761860","url":"https://clinicaltrials.gov/study/NCT05761860","phase":"Early phase 1","title":"The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults","status":"recruiting","sponsor":"University of Florida","countries":["United States"],"us_states":["Florida"]},{"nct":"NCT05754073","url":"https://clinicaltrials.gov/study/NCT05754073","phase":"Phase 2","title":"Oxytocin Effects on Bone in Children With Autism Spectrum Disorder","status":"recruiting","sponsor":"Elizabeth Austen Lawson","countries":["United States"],"us_states":["Massachusetts","Virginia"]},{"nct":"NCT05864508","url":"https://clinicaltrials.gov/study/NCT05864508","phase":"Phase 2","title":"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.","status":"not-yet-recruiting","sponsor":"University Hospital, Toulouse","countries":["France"],"us_states":[]},{"nct":"NCT05664516","url":"https://clinicaltrials.gov/study/NCT05664516","phase":"Phase 2","title":"A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder","status":"recruiting","sponsor":"Massachusetts General Hospital","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT04218409","url":"https://clinicaltrials.gov/study/NCT04218409","phase":"Early phase 1","title":"Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination","status":"recruiting","sponsor":"University of Florida","countries":["United States"],"us_states":["Florida"]},{"nct":"NCT03860233","url":"https://clinicaltrials.gov/study/NCT03860233","phase":"Phase 1","title":"Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine","status":"recruiting","sponsor":"Vivek Jain","countries":["United States"],"us_states":["District of Columbia"]}],"aliases":["Pitocin"],"summary":"A hormone sold as a prescription shot to start or strengthen labor and to control bleeding after birth.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261","tier":"primary","type":"regulatory","title":"Drugs@FDA: Pitocin injection, application 018261"},{"n":2,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248","tier":"primary","type":"regulatory","title":"Drugs@FDA: oxytocin injection, application 018248"},{"n":3,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad","tier":"primary","type":"label","title":"DailyMed: Pitocin (oxytocin injection) label, updated May 2026"},{"n":4,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7fd585a-99b7-4309-b003-a6cbef05372c","tier":"primary","type":"label","title":"DailyMed: oxytocin injection label, revised July 2023"},{"n":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=012285","tier":"primary","type":"regulatory","title":"Drugs@FDA: Syntocinon nasal solution, application 012285, discontinued"},{"n":6,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":7,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list, updated May 2026"},{"n":8,"url":"https://www.fda.gov/media/94164/download","tier":"primary","type":"regulatory","title":"FDA: 503B bulk drug substances category list, updated March 2025"},{"n":9,"url":"https://www.fda.gov/media/98973/download","tier":"primary","type":"regulatory","title":"FDA guidance: compounded drugs that are essentially copies, January 2018"},{"n":10,"url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedium-services-llc-issues-voluntary-nationwide-recall-all-unexpired-lots-oxytocin-compounded","tier":"primary","type":"regulatory","title":"FDA-posted recall notice: compounded oxytocin drip bags weaker than labeled, 2017"},{"n":11,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quva-pharma-inc-675685-01262024","tier":"primary","type":"regulatory","title":"FDA warning letter to an outsourcing facility that recalled an oxytocin batch, 26 January 2024"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/29693726/","tier":"peer-reviewed","type":"systematic-review","title":"Cochrane network meta-analysis: drugs to prevent heavy bleeding after birth, 2018"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/34644471/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: nasal oxytocin in children and teens with autism, 2021"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/42134427/","tier":"peer-reviewed","type":"systematic-review","title":"Meta-analysis: nasal oxytocin trials in mental disorders, 2026"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/29232031/","tier":"peer-reviewed","type":"systematic-review","title":"Review: unwanted effects of long-term nasal oxytocin in autism, 2018"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/34379318/","tier":"peer-reviewed","type":"reference","title":"Case report: water intoxication during labor stimulated with oxytocin, 2021"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/11588199/","tier":"peer-reviewed","type":"animal","title":"Mouse study: oxytocin in the medial amygdala and social recognition, 2001"},{"n":18,"url":"https://clinicaltrials.gov/study/NCT06194851","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06194851: nasal oxytocin with couples therapy for veterans with PTSD"},{"n":19,"url":"https://clinicaltrials.gov/study/NCT05754073","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05754073: nasal oxytocin and bone health in children with autism"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT06364228","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06364228: nasal oxytocin for caregivers of persons with dementia"},{"n":21,"url":"https://www.healio.com/news/primary-care/20211014/oxytocin-does-not-improve-social-functioning-in-children-with-autism-study-finds","tier":"established-news","type":"reference","title":"Healio: oxytocin does not improve social functioning in children with autism, 2021"}],"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]."],"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.","evidence_grade":"moderate-human","open_questions":["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]."],"section_routes":"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].\n\nPharmacies 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].\n\nNasal 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.","regulatory_as_of":"2026-10-26","section_channels":"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].\n\nNo FDA page we found describes nasal oxytocin sold straight to consumers. So this page does not describe that channel.","section_evidence":"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].\n\nNasal 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].\n\nMuch 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.","regulatory_status":"fda-approved","section_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].\n\nThe 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].\n\nResearchers 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].","section_is_it_legal":"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.\n\nThe 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.\n\nPharmacies 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].","unofficial_channels":[{"type":"compounding-outside-the-rules","what_it_is":"Oxytocin mixed by compounders, such as ready-to-use drip bags sold to hospitals.","enforcement":[{"date":"2024-01-26","text":"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.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quva-pharma-inc-675685-01262024"}],"legal_position":{"text":"Outsourcing facilities must follow factory quality rules. A drug made in unclean conditions is adulterated, and shipping it breaks federal law.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quva-pharma-inc-675685-01262024"},"documented_risks":[{"text":"In 2017, a compounder recalled oxytocin drip bags made for hospitals after tests found them weaker than expected.","source_url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedium-services-llc-issues-voluntary-nationwide-recall-all-unexpired-lots-oxytocin-compounded"},{"text":"FDA inspectors found mold on glove samples and poor clean-room practice at an outsourcing facility that had recalled an oxytocin batch with the wrong 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