Oxytocin: Safety Profile & Research Summary
24 PubMed CitationsExpert ReviewedGMP CertifiedLast Reviewed: February 2026
Preclinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Shin et al. (2025) | 12-mo C57BL/6J mice — 0.5 mg/kg IP 5x/wk × 13 wk | Discrimination Index ↑ (p<0.01); hippocampal DCX+ cells ↑; GluR1 133%↑, NMDAR2B 101.7%↑ → reversed age-related memory loss | [16] |
| Chavez et al. (2024) | Fmr1-KO mice (Fragile X/ASD) — IN OXT postnatal wk 2 | Fully restored episodic memory and hippocampal LTP in adulthood via NMDAR recovery | [17] |
| Elabd et al. (2014) | Oxt-/- mice — systemic OXT rescue | Premature sarcopenia/osteoporosis confirmed; reversible with OXT; necessary for muscle stem cell regeneration | [14] |
| Petersson et al. (1996) | SHR rats — 1 mg/kg SC × 5 days | 21 mmHg SBP reduction (p<0.01); effect persisted 3 days post-treatment; males only | [12] |
| Blevins et al. (2015) | Obese rhesus monkeys — SC 2x/day × 4 wk | Significant weight loss; ↑free fatty acids/glycerol; ↓triglycerides | [18] |
| Kobayashi et al. (2009) | Rat ischemia-reperfusion | ↑Bcl-2, ↓Caspase-3/Bax → cardiomyocyte survival; improved cardiac remodeling | [6] |
| Marlin et al. (2015) | Virgin female mice — optogenetic OXT | Transient ↓inhibitory PSCs → excitatory LTP → onset of maternal pup retrieval behavior | [19] |
| Szeto et al. (2013) | Watanabe Hyperlipidemic Rabbits | Attenuated atherosclerosis and adipose tissue inflammation | [20] |
Human Clinical Data: Obstetrics
| Trial | Population | Intervention | Key Results | Ref |
|---|---|---|---|---|
| Pathak et al. (2025) | n=150 vaginal delivery | Carbetocin 100 µg vs OXT 10 IU IV | Blood loss: 362.5 vs 392.9 mL (p=0.00004) | [4] |
| Suryawanshi et al. (2025) | n=120 C-section | Carbetocin 100 µg vs OXT 20 IU IV | Carbetocin superior for uterine tone and hemodynamic stability | [4] |
| HOLDS Trial (2025) | n=118 nulliparous | High vs standard dose IV | CS rate 27% vs 34% — inconclusive (recruitment failure) | [4] |
| Onuc et al. (2025) | n=904 observational | Intrapartum synOT | PPD rate 21% vs 37% without (p<0.001) | [15] |
Human Clinical Data: Metabolic / ASD / Psychiatric / PWS
| Trial | Indication | Population | Key Results | Ref |
|---|---|---|---|---|
| Plessow et al. (2024) | Obesity (NEJM Evidence) | n=61; 24 IU IN 4x/day × 8 wk | Failed primary (weight); reduced caloric intake -152 kcal/meal | [9] |
| Espinoza et al. (2021) | Sarcopenic obesity | n=21; 24 IU IN 4x/day × 8 wk | Lean mass +2.25 kg; LDL -19.3 mg/dL | [10] |
| Zhang et al. (2025) | ASD meta-analysis | 12 RCTs, n=498 | 48 IU/day optimal (SMD = -1.13); inverted-U dose-response | [7] |
| Sikich et al. (2021) | ASD (NEJM) | n≈290 children/adolescents | No significant benefit on social function | [8] |
| Ellenbogen et al. (2024) | MDD adjunctive | n=23; 24 IU IN before psychotherapy | Improved working alliance; reduced depression (Cohen's d = 0.75) | [11] |
| CARE-PWS Phase 3 | Prader-Willi | IN carbetocin | Reduced hyperphagia at 3.2 mg; NOT at 9.6 mg | [13] |
| Hollander et al. (2021) | Pediatric PWS | n=35; 16 IU IN × 8 wk | Improved hyperphagia and repetitive behaviors | [13] |
Safety Summary
| Parameter | Finding |
|---|---|
| Common AEs | Nasal irritation (IN), uterine cramping (women) |
| Serious Risks | Hyponatremia/water intoxication (V2 cross-reactivity); uterine hyperstimulation → rupture/fetal distress; hypotension, arrhythmia; BPD hypermentalization |
| Fetal/Neonatal | Bradycardia, arrhythmias, CNS damage, seizures, jaundice, low Apgar scores |
| Classification | NIOSH Group 3 hazardous drug — double chemotherapy gloves + protective gown |
| BBB Penetration | IN: <1% crosses BBB, but sufficient for behavioral effects |
| Drug Interactions | Vasoconstrictors → severe hypertension; cyclopropane → arrhythmia; QT-prolonging drugs → additive risk |
| Contraindications | CPD, unfavorable fetal position, fetal distress, uterine hyperactivity, placenta previa |
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References
- du Vigneaud V, Ressler C, Trippett S. The sequence of amino acids in oxytocin, with a proposal for the structure of oxytocin. Journal of Biological Chemistry. 1953;205(2):949-957.
- du Vigneaud V, Ressler C, Swan JM, Roberts CW, Katsoyannis PG, Gordon S. The synthesis of an octapeptide amide with the hormonal activity of oxytocin. Journal of the American Chemical Society. 1953;75(19):4879-4880.
- Gimpl G, Fahrenholz F. The oxytocin receptor system: structure, function, and regulation. Physiological Reviews. 2001;81(2):629-683.
- Salati JA, Leathersich SJ, Williams MJ, Cuthbert A, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database of Systematic Reviews. 2019;4(4):CD001808.
- Young LJ, Wang Z. The neurobiology of pair bonding. Nature Neuroscience. 2004;7(10):1048-1054.
- Gutkowska J, Jankowski M. Oxytocin revisited: its role in cardiovascular regulation. Journal of Neuroendocrinology. 2012;24(4):599-608.
- Zhang Y, Zhang X, Huang L. Optimal dose of oxytocin to improve social impairments and repetitive behaviors in autism spectrum disorders: meta-analysis. Frontiers in Psychiatry. 2025;15:1477076.
- Sikich L, Kolevzon A, King BH, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder. New England Journal of Medicine. 2021;385(16):1462-1473.
- Plessow F, Kerem L, Wronski ML, et al. Intranasal oxytocin for obesity. NEJM Evidence. 2024;3:EVIDoa2300349.
- Espinoza SE, Lee JL, Wang CP, et al. Intranasal oxytocin improves lean muscle mass and lowers LDL cholesterol in older adults with sarcopenic obesity. Journal of the American Medical Directors Association. 2021;22(9):1877-1882.e2.
- Giannoulis E, Andreini E, Santambrogio J, et al. The interplay between borderline personality disorder and oxytocin. Brain Sciences. 2025.
- Petersson M, Alster P, Lundeberg T, Uvnäs-Moberg K. Oxytocin causes a long-term decrease of blood pressure in female and male rats. Physiology & Behavior. 1996;60(5):1311-1315.
- Hollander E, Jacob S, Engel A, et al. Intranasal oxytocin for Prader-Willi syndrome. Journal of Psychiatric Research. 2021;142:311-318.
- Elabd C, Cousin W, Upadhyayula P, et al. Oxytocin is an age-specific circulating hormone that is necessary for muscle maintenance and regeneration. Nature Communications. 2014;5:4082.
- Onuc ME, et al. Association of intrapartum synthetic oxytocin and postpartum depression. Psychiatry International. 2025.
- Shin H, et al. Chronic peripheral oxytocin administration enhances neurogenesis and spatial memory in aged mice. 2025.
- Chavez CM, et al. Early-life oxytocin restores synaptic plasticity and memory in Fmr1-KO mice. 2024.
- Blevins JE, Graham JL, Morton GJ, et al. Chronic oxytocin administration inhibits food intake, increases energy expenditure, and produces weight loss in fructose-fed obese rhesus monkeys. American Journal of Physiology. 2015;308(5):R431-R438.
- Marlin BJ, Mitre M, D'amour JA, Chao MV, Bhatt D, Bhatt R, Bhatt DL, Bhatt DL, Froemke RC. Oxytocin enables maternal behaviour by balancing cortical inhibition. Nature. 2015;520(7548):499-504.
- Szeto A, Nation DA, Mendez AJ, et al. Oxytocin attenuates NADPH-dependent superoxide activity and IL-6 secretion in macrophages and vascular cells. American Journal of Physiology. 2008;295(6):E1495-E1501.
- Rajamannar P, Blechman J, Raz O, Levkowitz G. Neuropeptide oxytocin facilitates its own brain-to-periphery uptake. Cell Reports. 2025;44(4):115491.
- Lawson EA. The effects of oxytocin on eating behaviour and metabolism in humans. Nature Reviews Endocrinology. 2017;13(12):700-709.
- Blevins JE, Baskin DG. Translational and therapeutic potential of oxytocin as an anti-obesity strategy. Physiology & Behavior. 2015;152(Pt B):438-449.
- Insel TR. Is social attachment an addictive disorder? Physiology & Behavior. 2003;79(3):351-357.
Related Research Questions
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