Oxytocin: what the studies show, status and safety
Summary
Oxytocin is a hormone the body makes itself, and a prescription medicine used in childbirth. In all seven markets on this page it is prescription-only, and licensed for obstetric use alone. The cuddle hormone picture rests on one laboratory finding from 2005 that larger studies failed to reproduce. Trials in autism, schizophrenia, obesity and alcohol dependence came back negative.
Key findings at a glance
- Prescription-only in every market covered here, and licensed only for obstetric use. The oldest approval still on a register is Swiss and dates from 12 January 1956 [1].
- The one boxed warning on the American label is a ban on an indication, not a side-effect warning. Oxytocin is not indicated for starting labour without a medical reason, because the data are too thin to weigh benefit against risk [2].
- The largest trial in autism found nothing. In 290 children and teenagers treated for 24 weeks, the difference against dummy treatment was -0.2 points (confidence interval -1.5 to 1.0), p = 0.61 [3].
- A 2026 pooling of randomised trials agreed. Across 733 participants in 12 trials the standardised difference was -0.05 (confidence interval -0.20 to 0.10), p = 0.54 [4].
- The trust finding did not replicate. Two registered replications with 321 and 211 participants found no effect. Pooled testing across 532 people placed any remaining effect below the size worth studying [5], [6].
- It does work for the job it is licensed for. Against no treatment it cut bleeding of at least 500 ml after birth to an odds ratio of 0.53, range 0.45 to 0.62. That comes from trustworthy data in 6,003 women [7].
- Weight loss failed as well. After eight weeks in 61 adults with obesity, weight moved by 0.20 kilograms on oxytocin against 0.26 kilograms on dummy treatment, p = 0.934 [8].
- The main danger is overstimulation of the womb. The German product information classes contractions that are too strong, with the baby short of oxygen, as very common, meaning at least one case in ten [9].
- Not on the 2026 anti-doping list. A full-text search of the prohibited list returns the word oxytocin zero times [10].
What it is
Oxytocin is a small hormone of nine building blocks, released by the pituitary gland at the base of the brain. It makes the muscle of the womb contract during labour, and it drives the release of milk during breastfeeding [2], [11].
The medicine is made chemically rather than extracted from tissue. The American product information gives the reason: synthesis avoids contamination with vasopressin, a closely related hormone, and with other small peptides that have effects of their own [2].
Licensed products are injections, sold in the United States as Pitocin and in Switzerland and elsewhere as Syntocinon [12], [1]. Switzerland is the only market here that also has a licensed nasal spray. That spray is licensed to help milk flow and to prevent inflammation of the breast, and for nothing else [11].
Vincent du Vigneaud is generally credited with working out the structure and making oxytocin chemically in the 1950s. This register could not confirm that from a primary source, so it is offered as background rather than as a checked fact.
Quick facts
| Field | Value | Ref |
|---|---|---|
| INN | Oxytocin | [13] |
| Class | Nine-building-block hormone of the pituitary; makes the womb contract | [2] |
| Structure | Nine amino acids, with a sulphur bridge closing a ring between the first and the sixth | [13] |
| Formula | C43H66N12O12S2 | [13] |
| Mass | 1007.2 g/mol | [13] |
| How it is given | Into a vein or into a muscle; as a nasal spray only in Switzerland | [2], [11] |
| How long it lasts | 1 to 6 minutes in the American label, 3 to 20 minutes in the European ones | [2], [9] |
| How fast it acts | Almost at once into a vein; 3 to 5 minutes into a muscle, then lasting 2 to 3 hours | [2] |
| How it is cleared | Broken down by an enzyme of pregnancy called oxytocinase, and by liver and kidney; under 1 percent leaves unchanged in urine | [2] |
| Taken by mouth | Inactive | [2] |
| Status | Prescription-only in all seven markets on this page | [12], [14], [1], [15], [16] |
| ATC code | H01BB02 | [1] |
| CAS registry number | 50-56-6 | [13] |
| UNII | 1JQS135EYN | [17] |
| ChEMBL and ChEBI | CHEMBL395429; CHEBI:7872 | [18] |
| PubChem | 439302 | [13] |
| Registered studies | 925 | [19] |

How it works
Oxytocin acts on a receptor of its own in the muscle of the womb, and the number of those receptors climbs steeply through pregnancy [2].
- In the womb. The receptor raises calcium inside the muscle cell. That switches on the machinery that makes the muscle shorten. Receptor numbers peak in early labour at term, which is why the same amount does very different things at different points in pregnancy [2].
- In the breast. Oxytocin squeezes the cells around the milk ducts, which pushes milk out. This is the effect the Swiss nasal spray is licensed for [11].
- Two building blocks from vasopressin. The American label notes that the two hormones differ in only two of eight positions. Oxytocin therefore raises blood pressure a little and holds water back, even in pure form [2].
- In the brain, in theory. Oxytocin also acts as a signalling substance between nerve cells, and that is the basis of the psychiatric research programme. Whether a nasal spray delivers useful amounts to the human brain is disputed [20], [21].
Carbetocin, the nearest relative in use, is a modified copy that lasts longer and survives without a cold chain. Vasopressin and its synthetic form desmopressin come from the same small family but act on water balance [22], [2].
What the studies found
Preventing heavy bleeding after birth
Individual participant data meta-analysis This is the use the evidence supports best.
Pooled patient-level data from four trials in 4,304 women, extended with trustworthy summary data to 6,003, compared oxytocin against no treatment. Bleeding of at least 500 ml fell to an odds ratio of 0.59, range 0.46 to 0.74. Bleeding of at least 1000 ml fell to 0.51, range 0.32 to 0.80 [7].
In the extended trustworthy dataset the figures were 0.53, range 0.45 to 0.62, and 0.59, range 0.48 to 0.71. One fifth of the studies screened, 21 percent, failed the trustworthiness criteria set in advance, and those studies reported larger benefits [7].
Cochrane network meta-analysis A comparison of every agent used for this purpose covered 122 trials in 121,931 women across 48 countries.
Ergometrine together with oxytocin beat oxytocin alone for bleeding of at least 500 ml, risk ratio 0.76, range 0.64 to 0.90, at high trustworthiness. Misoprostol together with oxytocin probably did too, at 0.70, range 0.57 to 0.87 [23].
Carbetocin, injectable prostaglandins and ergometrine worked much like oxytocin. For the heavier threshold of 1000 ml the differences all but vanished, while misoprostol on its own may be worse, at 1.24, range 1.06 to 1.46. Every agent except carbetocin carried more side effects than oxytocin [23].
Non-inferiority trial The largest single trial randomised 29,645 women at 23 centres in ten countries, comparing heat-stable carbetocin against oxytocin after vaginal birth.
For bleeding of at least 500 ml or the need for another agent, the rates were 14.5 percent against 14.4 percent, risk ratio 1.01, range 0.95 to 1.06. That sits inside the non-inferiority margin of 1.16 [22].
For bleeding of at least 1000 ml the rates were 1.51 percent against 1.45 percent, risk ratio 1.04, range 0.87 to 1.25. Here the range crossed the margin of 1.23, so non-inferiority was not shown [22].
Dose-response meta-analysis Pooling 13 trials in 8,961 women found a J-shaped curve rather than a straight line.
The lower levels tested produced 6 to 7 fewer women per 1000 with bleeding of at least 1000 ml, against a background risk of 19 per 1000, at high trustworthiness. They also spared 10 to 12 women per 100 the need for another agent, against 26 per 100 without oxytocin [24].
Above that band the extra benefit fell away, and the need for other agents may rise. For blood transfusion no relationship with the amount given appeared at all [24].
Inducing and managing labour
Cochrane review Nine trials in 4,814 women asked whether the drip can be stopped once labour is established.
Stopping made little difference to the caesarean rate, risk ratio 0.98, range 0.85 to 1.13, at low trustworthiness. It made none to assisted vaginal birth, 1.05, range 0.90 to 1.21, at high trustworthiness [25].
Labour then took 34.72 minutes longer on average, range 26.34 to 43.11, at very low trustworthiness. Overstimulation of the womb fell, risk ratio 0.65, range 0.55 to 0.77, and admissions to the newborn unit did not change [25].
Cochrane network meta-analysis A comparison of 13 ways to start labour covered 106 trials in 30,348 women at or past term.
No method clearly beat vaginal misoprostol for achieving vaginal birth within a day. Oxytocin combined with breaking the waters ranked among the leading options, risk ratio 0.41, range 0.14 to 1.24, at moderate trustworthiness, though the wide range leaves the question open [26].
Deaths around birth were far too rare for any conclusion, with ten cases in all the trials together [26].
Autism
Phase 2 RCT The decisive trial randomised 290 children and teenagers aged 3 to 17, and treated them for 24 weeks. Analysis covered 277 of them, 139 on oxytocin and 138 on dummy treatment.
The main measure was a 13-item scale of social withdrawal running from 0 to 39. Scores improved by 3.7 points on oxytocin and by 3.5 points on dummy treatment. The difference of -0.2 points favoured placebo (95 percent confidence interval -1.5 to 1.0), p = 0.61 [3].
Change on a 13-item social withdrawal scale running from 0 to 39. Larger falls are better. 290 children and teenagers aged 3 to 17. Source [3].
Secondary measures generally did not separate either, and side effects were similar in both groups. This was the trial the field had been waiting for, and it was clearly negative [3].
Meta-analysis A 2026 review restricted to randomised trials pooled 733 participants from 12 studies, adults and children. The standardised difference on social measures was -0.05 (confidence interval -0.20 to 0.10), p = 0.54. Disagreement between the trials was minimal, with I-squared at 4 percent [4].
Meta-analysis, mixed designs An earlier pooling of 28 studies in 726 people did report a benefit for social functioning. It included open-label, single-arm and uncontrolled work alongside randomised trials [27].
The two results are not a change of knowledge but a change of method. Once uncontrolled studies are excluded, the effect disappears [4], [27].
Other psychiatric conditions
Meta-analysis The broadest pooling covered 42 double-blind randomised trials in 1,922 people, across autism, schizophrenia, substance use and other diagnoses.
The overall effect was small and not significant, Hedges g = 0.17 (confidence interval -0.05 to 0.38). Disagreement between trials was wide, I-squared 77.4 percent. Removing two outliers cut the estimate to g = 0.05 (confidence interval -0.03 to 0.12) and the disagreement to nothing [28].
Within schizophrenia a small significant effect remained, g = 0.12, range 0.01 to 0.23. Neither the amount given, the number of doses, added psychological therapy nor age changed the picture [28].
Meta-analysis In schizophrenia specifically, ten double-blind trials in 344 people found no difference in overall symptoms. The standardised difference was -0.08 (confidence interval -0.53 to 0.37), p = 0.74, across eight of those trials in 203 people, with disagreement between them at I-squared 59 percent [29].
Positive, negative and general symptoms were no different either, with p values from 0.28 to 0.78. Only the highest amount tested showed an advantage in the dose-response analysis, p = 0.02 for overall symptoms. Dropouts and side effects matched placebo, risk ratio 1.12, range 0.67 to 1.88 [29].
Meta-analysis A separate review of nine trials on negative symptoms reached the same place. Higher amounts appeared to help at moderate effect size, but that signal vanished when one outlying trial was removed [30].
Meta-analysis For alcohol use disorder, six randomised trials gave a pooled Hedges g of 0.34 (confidence interval -0.48 to 1.17), p = 0.47. Disagreement between the studies was heavy, Q(48) = 504.40, p below 0.001.
A Bayesian analysis confirmed the absence of a credible effect, posterior mean -0.005 (credible interval -0.53 to 0.52). A robust Bayesian model favoured no effect by a factor of 4.74, and variance analysis found no hidden group of responders [31].
Trust: a replication story
Randomised laboratory study In 2005 a study in healthy men reported that oxytocin given by nose raised trust in an economic game, and did so without raising general risk-taking. This single paper is the origin of the whole cuddle hormone story [32].
Registered replication A large double-blind replication in 321 participants, powered above 95 percent, found no effect on trusting behaviour in the condition the original had used. An exploratory finding in people low in trust needs confirmation [5].
Registered report A second replication added 211 people and pooled them with the earlier sample, giving 532 in all. Equivalence testing showed any effect to be too small to matter for laboratory research. Baseline trust, reward sensitivity and punishment sensitivity did not change that [6].
The 2005 finding came from a single laboratory study. Later registered work tested far more people and found no effect. Sources [5], [6].
Critical review A survey of the wider field reached the same verdict earlier. Measurements of oxytocin in blood are error-prone, and large samples found no consistent link between variants of the oxytocin receptor gene and trust [33].
Weight and eating
Randomised placebo-controlled trial The only adequately sized weight trial treated 61 adults with obesity for eight weeks. Average age was 33.6 plus or minus 6.2 years and average body mass index 36.9 plus or minus 4.9.
Weight changed by 0.20 kilograms on oxytocin and 0.26 kilograms on placebo, p = 0.934. Body composition and resting energy use did not improve either. Total fat differed by 196.0 grams (confidence interval -1036 to 1428). Resting energy use differed by -64.0 kilocalories per day (confidence interval -129.3 to 1.4) [8].
One measure did move. At a test meal, intake fell by 31.4 kilocalories on oxytocin while rising by 120.6 on placebo, a difference of -152.0 kilocalories, range -302.3 to -1.7. That did not translate into weight change [8].
Pilot crossover trial In hypothalamic obesity after a brain tumour, 13 people aged 10 to 35 were randomised and 10 finished. Median age was 15.3 years. Weight changed by -0.6 kilograms on oxytocin (confidence interval -2.7 to 1.5), which is not significant [34].
Five of the 13 randomised participants showed a prolonged QTc interval on the heart tracing, though under both treatments and partly before screening [34].
Meta-analysis In Prader-Willi syndrome, three randomised trials found no effect on excessive hunger, mean difference 0.18 (confidence interval -0.44 to 0.80), p = 0.56, in 92 patients. Weight did not move either, 0.30 (confidence interval -0.22 to 0.83), p = 0.25, in 94 patients [35].
Meta-analysis Twelve controlled studies, mostly single-dose, covered 266 people without psychiatric illness and 157 with. Food intake fell in the first group, standardised difference -0.66 (confidence interval -1.18 to -0.14) [36].
Nothing appeared in anorexia nervosa, 0.17 (confidence interval -0.32 to 0.66), in bulimia and binge eating, -0.41 (-0.94 to 0.11), or in schizophrenia, 0.04 (-0.94 to 1.02). Craving, hunger, anxiety and stress were unchanged in every subgroup [36].
What is still unknown
- No cancer, mutation or fertility studies exist. The American label says so in as many words, and animal reproduction studies were never done [2]. The German product information adds that genotoxicity was never tested in living animals [9].
- No data in liver or kidney impairment, in children and teenagers, or in people aged 65 and over [9].
- Build-up during longer use is possible because of the water-retaining effect and reduced clearance by the kidney, but firm data are missing [9].
- How much of a nasal dose reaches the human brain is unsettled. The figure often quoted, that over 95 percent of brain oxytocin arrives directly from the nose, comes from rats [20].
- Long-term nasal safety in children is thin. The largest safety pooling in autism covers 223 participants from five trials [37].
- Proper human dose-response work is missing for the nasal route, with control conditions that separate effects in the body from effects in the brain [21].
Side effects and safety
The American label carries a single boxed warning, and it restricts an indication rather than describing a side effect. Starting labour where there is no medical reason to do so is ruled out, because the available data are inadequate to weigh benefits against risks [2].
The dangerous effects come from two directions: too much contraction of the womb, and the water-retaining property oxytocin shares with vasopressin [2], [9].
- Overstimulation of the womb. The German product information classes contractions that are too strong as very common, meaning at least one case in ten. They can lock the womb and leave the baby short of oxygen [9].
- What overstimulation can lead to. The American label lists precipitate delivery, rupture of the womb, tears of the cervix and vagina, bleeding after birth, poor blood flow to the placenta and fetal death [2].
- Deaths of mothers have been reported with parenteral oxytocic drugs used to start or strengthen labour, through high blood pressure episodes, bleeding under the lining of the brain and rupture of the womb [2].
- Water intoxication. Oxytocin holds water back in the kidney. Severe intoxication with fits and coma has occurred under a slow infusion running over a day, and one maternal death is on record. The German label classes this as very rare [2], [9].
- Sudden fall in blood pressure. A rapid injection into a vein can cause flushing, a reflex fast heartbeat and low blood pressure. In people with heart disease that can starve the heart muscle. The British product information is categorical: oxytocin must only be given as an infusion and never as a bolus into a vein [38], [9].
- Heart rhythm. A prolonged QTc interval is documented after rapid injection into a vein [9].
- Common complaints. Headache, fast or slow heartbeat, a rise in blood pressure, nausea and vomiting are all classed as common in Europe. Allergic reactions and rhythm disturbance are uncommon [9].
- Rare but serious. Anaphylaxis with breathlessness, low blood pressure or shock is rare, as is clotting throughout the bloodstream. That last one has been put at an incidence below 0.0006 [2], [9].
- In the baby. Slow heartbeat, extra beats, low Apgar scores at five minutes, jaundice, retinal bleeding, fits, lasting brain damage and death are all listed [2].
- With the nasal spray. The Swiss product information reports abnormal contractions of the womb and allergic skin inflammation as uncommon. No anaphylaxis has been reported for that form [11].
- In nasal research use. Pooling five randomised trials in 223 people gave nasal discomfort in 14.3 percent, irritability in 9.0 percent and tiredness in 7.2 percent. Diarrhoea and skin irritation each reached 4.5 percent. None was statistically linked to the treatment, all p above 0.1 [37].
Oxytocin must not be used where the baby cannot pass through, where it lies wrongly, where the womb is already overactive, or where vaginal birth is ruled out. The German label adds pre-eclampsia, an unripe cervix, placental problems and a threatened rupture [2], [9].
Two practical points close this out. Everyone receiving it into a vein must be watched continuously by trained staff, with a doctor able to manage complications immediately at hand [2]. The German licence permits use only in hospital and only under medical supervision [9].
Why this page lists no doses
Oxytocin is prescription-only in every market covered here, and its licensed use is confined to childbirth. There the amount is adjusted against the response of the womb and the heartbeat of the baby. Choosing it belongs in the approved product information and with the clinical team. That applies to the Swiss nasal spray as much as to the injection.
Development and approval status
Approval and evidence timeline
- 1950sSynthetic oxytocin reaches the marketVincent du Vigneaud is credited with the structure and the first chemical synthesis; not confirmed here from a primary source
- 1956Oldest approval still on a register, in Switzerland on 12 JanuaryInjection, approval number 22114, ref [1]
- 1959Swiss nasal spray approved on 9 SeptemberLicensed for milk flow and prevention of breast inflammation, approval number 25644, ref [1]
- 1977Added to the WHO list of essential medicinesListed under uterotonics for bleeding after birth, ref [39]
- 1980United States approval of the current injection on 19 NovemberApplication NDA018261, a reissue of older approvals, ref [12]
- 2005The trust finding is publishedA single laboratory study starts the cuddle hormone story, ref [32]
- 2018Heat-stable carbetocin tested against oxytocin in 29,645 womenNon-inferiority shown for one endpoint, not for the other, ref [22]
- 2021The decisive autism trial reports a negative result290 children and teenagers over 24 weeks, ref [3]
- 2024The obesity trial fails its main endpoint61 adults over eight weeks, ref [8]
- 2026Meta-analyses confirm the negative picture733 participants in autism and pooled equivalence testing on trust, refs [4], [6]
| Market | Status | Since or note | Ref |
|---|---|---|---|
| United States | Prescription | Injection only; nasal product discontinued | [12] |
| European Union | Prescription | National approvals; no central one | [9] |
| Germany | Prescription | Listed in Annex 1 of the prescription rules | [14] |
| United Kingdom | Prescription | Infusion concentrate, POM | [38] |
| Australia | Prescription | Schedule 4 of the poisons standard | [16] |
| Canada | Prescription | Marketed since 1981 | [15] |
| Switzerland | Prescription | Category B; only market with a nasal spray | [1] |
Two entries need a word. The German rules carry one narrow exception, for supply to midwives for use against bleeding after birth. It does not make oxytocin freely available and does not permit supply to private individuals [14].
The Swiss nasal spray is the one that gets misread. It is licensed for milk flow and for preventing inflammation of the breast, it needs a prescription, and it is expressly ruled out during pregnancy and birth [11].
Nothing anywhere is licensed for a psychiatric, social or sexual indication. A search of the American register on 10 September 2026 returned nine applications, all injections apart from one discontinued nasal solution [12].
Oxytocin does not appear on the American list of products withdrawn for safety or effectiveness [40]. It is also absent from the list of bulk substances for compounding. That is not a ban: a substance that matches a pharmacopoeia monograph, or sits in an approved product, may still be used [41].
The wider framework is set out under are peptides legal and FDA-approved peptides. Every entry describes the position on 10 September 2026.
Anti-doping
Oxytocin is not banned in sport. A full-text search of the 2026 prohibited list returns the word oxytocin zero times, in or out of competition, as an active substance or as an example [10].
The check matters because the list does name close relatives. Desmopressin, a synthetic form of vasopressin, appears in section S5 among the diuretics and masking agents [10]. German anti-doping law likewise omits oxytocin from its annex [42].
One caveat stands. The heading of section S2 also prohibits other substances with similar chemical structure or similar biological effects. Oxytocin is a close chemical relative of vasopressin, so an anti-doping body could argue from that clause [10]. Competitive athletes can document any medical use and ask their national agency. The wider picture is at peptides banned in sport.
The practical limit is not the sports rules but the prescription status. Obtaining or using oxytocin without a prescription remains unlawful in all seven markets, whatever the anti-doping list says [12], [14], [16].
Compared with related peptides
| Substance | What it acts on | Status | Strongest relevant result | Ref |
|---|---|---|---|---|
| Oxytocin | Its own receptor in the womb and breast | Prescription in seven markets | Bleeding of at least 500 ml after birth cut to an odds ratio of 0.53, range 0.45 to 0.62 | [7], [1] |
| Carbetocin | The same receptor, longer acting | Approved medicine, heat-stable form | Matched oxytocin at the 500 ml threshold, 14.5 against 14.4 percent; not shown at 1000 ml | [22], [23] |
| Desmopressin | The vasopressin receptors, for water balance | Prescription; banned in sport under section S5 | Not reported on this page | [10] |
| hCG | The receptor luteinising hormone uses | Prescription; banned in sport for men | Not reported on this page | [10] |
| Gonadorelin | The GnRH receptor in the pituitary | Prescription; banned in sport for men | Not reported on this page | [10] |
| Kisspeptin-10 | The kisspeptin receptor, upstream of GnRH | Investigational; banned in sport for men | Not reported on this page | [10] |
These neighbours are related by role rather than by chemistry. Carbetocin is the only true substitute, and its advantage is storage without refrigeration rather than better results [22].
Desmopressin sits closest chemically, and the difference in what the two do shows how little chemical similarity settles. Two building blocks apart, and one controls the womb while the other controls urine [2], [10].
The last three rows are hormones of reproduction that act at other points in the chain. All are prescription medicines, and the ones that stimulate testosterone are banned in sport, which oxytocin is not [10].
Common misconceptions
- "Oxytocin is the cuddle hormone." Cuddle hormone and love hormone are popular labels with no pharmacological content. The finding behind them came from one laboratory study in 2005, and registered replications in 321 and 211 people found nothing. The licensed indications are obstetric only [32], [5], [6], [2].
- "A nasal spray reliably reaches the brain." In rats about 2 percent of a nasal dose became available, and over 95 percent of brain oxytocin arrived directly from the nose. In humans the case is contested: little reaches the fluid around the brain, while levels in the body rise above normal [20], [21].
- "Oxytocin treats autism." No market licenses it for that. The decisive trial in 290 children and teenagers missed its main endpoint, p = 0.61. The 2026 pooling of randomised trials in 733 people found nothing either, p = 0.54 [3], [4], [12].
- "Meta-analyses prove it works in autism." It depends what a review includes. The 2021 pooling of 28 studies in 726 people took in open-label and uncontrolled work and reported benefit. Restricted to randomised trials, the effect is gone [27], [4], [28].
- "It is a natural hormone, so it is harmless." The German product information classes contractions that are too strong, with the baby short of oxygen, as very common. The American label lists rupture of the womb, fatal clotting failure, maternal deaths and lasting brain damage in the baby [2], [9].
- "Oxytocin and vasopressin are much the same, so oxytocin does nothing to water balance." They differ in only two of eight positions, which is precisely why oxytocin holds water back. That property causes its most dangerous effect, water intoxication with fits and coma [2].
- "Oxytocin and carbetocin are interchangeable." Carbetocin matched oxytocin at the 500 ml threshold but not at 1000 ml, where the range crossed the margin. Its real advantage is storage without a cold chain [22], [23].
- "Oxytocin is a weight-loss aid." The one adequately sized trial found no weight difference after eight weeks, p = 0.934, and no gain in body composition or resting energy use. Hypothalamic obesity and Prader-Willi syndrome gave the same answer [8], [34], [35].
- "No nasal spray is licensed anywhere, so any spray is illegal." Switzerland has licensed one since 9 September 1959, on prescription, for milk flow and prevention of breast inflammation. It is ruled out in pregnancy and birth, and licensed nowhere for psychiatric or social purposes [1], [11].
- "Research-grade oxytocin is a different legal category." A For Research Use Only label changes nothing in medicines law. Grey-market sellers sometimes claim cover from drug enforcement research exemptions. That is wrong twice over: oxytocin is not a controlled substance, so nothing of the kind applies, and the medicines law that does apply turns on what the substance is, not on how the label is worded [12].
- "The prescription injection and a grey-market spray are the same product." The licensed injection is standardised for strength, contains defined preservatives and buffers, and is batch-released. It may carry no more than 16 percent total impurities. Powders sold as research chemicals carry none of these guarantees [2], [43].
Frequently asked questions
Is oxytocin a prescription-only medicine?
Yes, in every market examined here. It is prescription-only in the United States, across the European Union through national approvals, in Germany, the United Kingdom, Australia, Canada and Switzerland. Australia lists it in Schedule 4 of its poisons standard, and Switzerland in supply category B. The World Health Organization also carries it on the list of essential medicines.
What is oxytocin actually licensed for?
Childbirth, and nothing else. The approved uses are starting labour where there is a medical reason, strengthening weak contractions, and controlling bleeding after birth or after a miscarriage. The American label rules out starting labour without a medical reason, in its only boxed warning. The Swiss nasal spray adds one further use, helping milk flow and preventing inflammation of the breast. No market has ever licensed oxytocin for a psychiatric, social or sexual indication.
Does oxytocin nasal spray make people more trusting or affectionate?
The evidence says no. The 2005 study that started the idea has not held up. A registered replication in 321 people found no effect in the condition the original used, and a second replication added 211 people. Pooled testing across 532 participants placed any remaining effect below the size worth studying in the laboratory.
Does oxytocin help with autism?
Not on the evidence available. The decisive trial treated 290 children and teenagers for 24 weeks and missed its main endpoint by a wide margin, p = 0.61. A 2026 pooling of randomised trials in 733 participants found no effect either, p = 0.54. Earlier positive reviews had included uncontrolled and open-label studies.
Is there a licensed oxytocin nasal spray anywhere?
Yes, in Switzerland, approved on 9 September 1959 and still on the register. It is licensed to help milk flow and to prevent inflammation of the breast, it requires a prescription, and it is expressly ruled out during pregnancy and birth. The United States had a nasal product historically, but it is no longer marketed.
Can oxytocin be used for weight loss?
No. The only adequately sized trial treated 61 adults with obesity for eight weeks and found weight changes of 0.20 against 0.26 kilograms, p = 0.934. Body composition and resting energy use did not improve. Trials in hypothalamic obesity and in Prader-Willi syndrome found nothing either.
What is the most serious risk of oxytocin?
Two risks stand out. Contractions that are too strong can starve the baby of oxygen and can tear the womb, and the German product information classes that as very common. The second is water intoxication, because oxytocin holds water back in the kidney; severe cases with fits and coma have occurred, and one maternal death is on record.
Is oxytocin banned in sport?
No. A full-text search of the 2026 prohibited list returns the word oxytocin zero times, and German anti-doping law omits it too. One caveat: the heading of section S2 also covers substances of similar structure or effect, and oxytocin is chemically close to vasopressin. The prescription requirement applies regardless of the sports rules.
How long does oxytocin stay in the body?
Not long, but the approved texts disagree on the figure. The American product information gives 1 to 6 minutes in the blood, shortened further in late pregnancy and during breastfeeding. European and British texts give 3 to 20 minutes. Both come from approved product information, and this register reports them side by side rather than picking one.
Why does this page list no oxytocin doses?
Because oxytocin is prescription-only everywhere covered here, and its licensed use is confined to childbirth. There the amount is adjusted continuously against the response of the womb and the heartbeat of the baby, under supervision in hospital. Choosing an amount belongs in the approved product information and with the clinical team, not on a reference page.
Sources
- Swissmedic. Lists of authorised human medicines and packs. Entries for authorisation number 22114 (injection and infusion concentrate, CD Pharma (Suisse) SA, ATC H01BB02, first authorised 12 January 1956, supply category B) and 25644 (nasal spray, first authorised 9 September 1959, supply category B). Checked 10 September 2026.
- U.S. Food and Drug Administration. Prescribing information for the oxytocin injection sold as Pitocin, Par Health USA. SPL set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad, effective 6 May 2026, revised March 2026, retrieved through the openFDA label interface on 10 September 2026.
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- PubChem (NCBI). Compound CID 439302, oxytocin: molecular formula C43H66N12O12S2, molecular mass 1007.2, InChIKey XNOPRXBHLZRZKH-DSZYJQQASA-N, IUPAC name and synonyms including CAS 50-56-6. Retrieved 10 September 2026.
- German ordinance on prescription-only medicines (Arzneimittelverschreibungsverordnung), Annex 1, entry for oxytocin, including the narrow exception for supply to midwives for practice use against bleeding after birth. Full text checked 10 September 2026.
- Health Canada. Drug Product Database, oxytocin products, status, schedule and route. DIN 00497398 Pfizer Canada ULC, DIN 02139561 Fresenius Kabi Canada, DIN 02550199 Hikma Canada, DIN 01944916 Lyphomed (cancelled post market), plus several veterinary authorisations. Retrieved 10 September 2026.
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Cite this page
The facts on this page were checked on 10 September 2026, and the register searches behind the status table were run on that date. Licensed medicines gain new warnings over time, so the version and the date matter as much as the text. On that day the ClinicalTrials.gov registry listed 925 registered studies of this substance [19].
myPeptides Research & Editing. (2026). Oxytocin: what the studies show, status and safety. Version 1.0, 10 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/oxytocin
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-10 | Initial publication |
Last verified: 10 September 2026. Next review: on a labelling change in any covered market, on a new systematic review of the nasal evidence, or on any change in the anti-doping classification.
