Oxytocin

Mechanism-of-action class: G-Protein-linked Receptor Interactions.

• IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction.

• Oxytocin injection (synthetic) is contraindicated in any of the following conditions: • Significant cephalopelvic disproportion; • Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies; • In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; • In cases of fetal distress where delivery is not imminent; • Prolonged use in uterine inertia or severe toxemia; • Hypertonic uterine patterns; • Patients with hypersensitivity to the drug; • Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.contraindicated

Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane. An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances. To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent. The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.

Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred and is associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: • Bradycardia • Premature ventricular contractions and other arrhythmias • Permanent CNS or brain damage • Fetal death Due to use of oxytocin in the mother: • Neonatal retinal hemorrhage • Low Apgar scores at five minutes • Neonatal jaundice

Overdosage with oxytocin injection (synthetic) depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H 2 O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion and variable deceleration of fetal heart, fetal hypoxia, hypercapnia or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods. Management consists of immediate discontinuation of oxytocin, and symptomatic and supportive therapy.

• Jul 9, 1980NDANDA018248Fresenius Kabi Usa
• Nov 19, 1980NDANDA018261Ph Health
• Feb 13, 2013ANDAANDA200219Hikma Farmaceutica

1. 1Foetal Exposure During Pregnancy43415%
2. 2Maternal Exposure During Pregnancy42915%
3. 3Drug Ineffective39313%
4. 4Exposure During Pregnancy36012%
5. 5Premature Baby2057.0%
6. 6Hypotension1916.5%
7. 7Off Label Use1876.4%
8. 8Premature Delivery1605.5%
9. 9Drug Exposure During Pregnancy1434.9%
10. 10Postpartum Haemorrhage1364.6%
11. 11Maternal Exposure During Delivery1234.2%
12. 12Caesarean Section1053.6%
13. 13Low Birth Weight Baby1043.5%
14. 14Nausea963.3%
15. 15Dyspnoea903.1%

Recent PubMed references pinned to Oxytocin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Oxytocin selectively biases sensory-prefrontal communication through network-level suppression and theta coupling.
  Proceedings of the National Academy of Sciences of the United States of America · 2026 · Jung D, Han HB, Kim J, et al.
  PMID 42263121DOI 10.1073/pnas.2603966123
• Effects of an informatized system based on the WHO "Safe Childbirth Checklist" combined with oxytocin on post-cesarean section hemorrhage.
  Medicine · 2026 · Yang J, Wu C
  PMID 42260833DOI 10.1097/MD.0000000000049031
• Salivary Oxytocin and Socio-Emotional Functioning in Children and Adolescents With and Without Autism Spectrum Disorder.
  Neuropsychopharmacology reports · 2026 · Ikehara M, Ishida R, Yamamuro K, et al.
  PMID 42241307DOI 10.1002/npr2.70138
• Conditional deletion of Cc2d1a increases irritability-like behavior by decreasing oxytocin expression via the prelimbic-hypothalamic pathway.
  Journal of biomedical science · 2026 · Cheng KH, Hung YC, Ling P, et al.
  PMID 42231358DOI 10.1186/s12929-026-01263-w
• [Decreased blood oxytocin levels in obesity and in patients with newly diagnosed type 2 diabetes].
  Problemy endokrinologii · 2026 · Anvarova SS, Narimova GD
  PMID 42227092DOI 10.14341/probl13587
• Protective Effects of Oxytocin on Experimental Colitis: Modulation of Cytokines, Oxidative Stress, and Caspase-3 Activity.
  Medicina (Kaunas, Lithuania) · 2026 · Aydinli Kazalak B, Yaman S, Ozcelik MF, et al.
  PMID 42195146DOI 10.3390/medicina62050893
• Dual Pathways Coupled to Oxytocin Molecular Signals in Cultured Astrocytes.
  Cells · 2026 · Farsetti E, Amato S, Averna M, et al.
  PMID 42193958DOI 10.3390/cells15100950
• Prophylactic oxytocin infusion for reducing blood loss during elective caesarean delivery: A randomised controlled trial.
  The Indian journal of medical research · 2026 · Govindan P, Sharma J, N S K, et al.
  PMID 42165728DOI 10.25259/IJMR_2952_2025

The 10 most recently updated of 914 ClinicalTrials.gov registrations naming Oxytocin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Social Safety Learning in the Brain Oxytocin System
  Completed · Phase 2 · Interventional · 121 enrolled · University of Washington
  NCT05968651updated 2026-06-11
• Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
  Not yet recruiting · Phase 4 · Interventional · 332 enrolled · Mansoura University
  NCT07636421updated 2026-06-09
• Positive Expectation Effects on Early Emotional Processing
  Not yet recruiting · Interventional · 51 enrolled · Universitätsklinikum Hamburg-Eppendorf
  NCT07615530updated 2026-06-02
• A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
  Recruiting · Phase 2 · Interventional · 60 enrolled · Massachusetts General Hospital
  NCT05664516updated 2026-05-28
• Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
  Not yet recruiting · Interventional · 40 enrolled · Aalto University
  NCT07214948updated 2026-05-27
• The Relationship Between Oxytocin Massage in Mothers With Insufficient Milk Production in the Early Postpartum Period and Breastfeeding Self-Efficacy and Milk Let-down Reflex: A Randomized Controlled Study
  Recruiting · Interventional · 128 enrolled · Tokat Gaziosmanpasa University
  NCT07609693updated 2026-05-27
• Efficacy of Intravenous Oxytocin to Speed Recovery After THA
  Enrolling by invitation · Phase 2 · Interventional · 80 enrolled · Wake Forest University Health Sciences
  NCT07430228updated 2026-05-27
• Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain
  Recruiting · Phase 2 · Interventional · 24 enrolled · Wake Forest University Health Sciences
  NCT07053774updated 2026-05-26
• Termination of Pregnancy in Previous Scarred Uterus: PGE1 Versus Cervical Folleys
  Completed · Phase 4 · Interventional · 60 enrolled · Dr Mudassar Saeed Pansota
  NCT07604051updated 2026-05-22
• Intact Cord Resuscitation in CDH
  Recruiting · Interventional · 180 enrolled · University Hospital, Lille
  NCT04429750updated 2026-05-20

Frequently asked questions

How does Oxytocin work?

Mechanism-of-action class: G-Protein-linked Receptor Interactions.

What is Oxytocin used for?

According to FDA labeling, Oxytocin carries indications including: IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxytocin?

Oxytocin is classified as Oxytocin and analogues, Oxytocic, G-Protein-linked Receptor Interactions, Increased Uterine Smooth Muscle Contraction or Tone.

What are the brand names for Oxytocin?

Oxytocin is marketed under brand names including Pitocin.

What are the contraindications for Oxytocin?

Oxytocin labeling lists contraindications including: Oxytocin injection (synthetic) is contraindicated in any of the following conditions: • Significant cephalopelvic disproportion; • Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies; • In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; • In cases of fetal distress where delivery is not imminent; • Prolonged use in uterine inertia or severe toxemia; • Hypertonic uterine patterns; • Patients with hypersensitivity to the drug; • Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.. Always consult the full prescribing information and a clinician.