Oxytocin is widely known for its role in labor and delivery, but many people are unsure how it works or what the data actually show about its safety profile. This overview summarizes what is documented in the product label, registered trials, and adverse event reports.
Key takeaways
- Oxytocin is classified among hormone-related drug classes, including oxytocic agents.
- More than 1,400 clinical trials have been registered studying oxytocin across a range of uses.
- Reported adverse events most frequently involve pregnancy exposure circumstances and drug effectiveness concerns.
- Hypotension is among the more commonly reported reactions.
- The compound has a PubChem CID of 439302 for chemical reference.
What Oxytocin Is
Oxytocin belongs to a group of hormone-based drug classes referenced on its label, including oxytocic agents. Oxytocic agents are typically associated with effects on uterine activity. The label does not provide further detail on its mechanism of action.
What Oxytocin Is Approved For
Labeling data associated with this product is limited and does not clearly describe the approved indications in standard terms. A brand name, GUNA-GERIATRICS, appears in the available label data. No boxed warning is present for this product.
What the Evidence Shows
Oxytocin has been studied in more than 1,400 registered clinical trials. One completed Phase 2 trial compared oxytocin to placebo for treating hyperphagia in children and adolescents with Prader-Willi syndrome. Another completed trial examined the effect of synthetic oxytocin administered during labor on breastfeeding outcomes, while a separate completed study looked at intranasal neuropeptide effects on emotion perception in people with trait anxiety.
Reported Side Effects
Adverse event reports are counts of submitted reports, not confirmed incidence or proof of causation. The most frequently reported events relate to pregnancy exposure, including foetal exposure during pregnancy (456 reports), maternal exposure during pregnancy (441), and exposure during pregnancy generally (366). Drug ineffective was also commonly reported (402), along with premature baby (209) and premature delivery (163). Hypotension (196) and off label use (191) were reported as well, reflecting a mix of effectiveness, physiological, and use-pattern concerns.