Carbetocin dosage in published studies and labels
These are the doses used for Carbetocin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Carbetocin has no FDA-approved dosage; there is no carbetocin label on DailyMed. Human dosing comes from trials: a single 100 mcg injection right after birth, intramuscular after vaginal birth in the WHO CHAMPION trial and intravenous at planned caesarean delivery, and a separate nasal-spray programme in Prader-Willi syndrome that tested 3.2 mg and 9.6 mg three times daily and did not meet its primary endpoints.
| Human dosing established | Yes |
|---|---|
| Route | Intramuscular · Intravenous · Intranasal |
| Frequency | Single dose after delivery (postpartum hemorrhage trials); three times daily (Prader-Willi nasal trials) |
| Duration studied | One dose after birth; 8–12 weeks in the Prader-Willi trials |
| Evidence level | Clinical Trial Evidence |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| WHO CHAMPION trial — heat-stable carbetocin after vaginal birth, NEJM 2018Clinical trial · Randomised, double-blind noninferiority trial | Women giving birth vaginally at 23 sites in 10 countries (29,645 randomised) | Heat-stable carbetocin 100 mcg, or oxytocin 10 IU | Intramuscular | Once, immediately after birth | Single dose | Blood loss of at least 500 mL or extra uterotonics: 14.5% with carbetocin versus 14.4% with oxytocin (noninferior); noninferiority was not shown for blood loss of at least 1,000 mL (1.51% versus 1.45%) | Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018. |
| Planned caesarean delivery — Oslo trial, BJOG 2025 (NCT03899961)Clinical trial · Double-blind randomised controlled trial | Women aged 18–50 with a singleton pregnancy having a planned caesarean delivery (240 randomised, 215 treated) | Carbetocin 100 mcg, or oxytocin 2.5 IU | Intravenous | Once, immediately after delivery | Single dose | No difference in troponin change (primary endpoint) or estimated blood loss; rescue treatment was needed less often with carbetocin (27.2% versus 46.4%) | Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial. BJOG. 2025. |
| CARE-PWS — phase 3, intranasal carbetocin in Prader-Willi syndrome (NCT03649477)Clinical trial · Randomised, double-blind, placebo-controlled phase 3 trial | Children and adolescents aged 7–18 with Prader-Willi syndrome (n=130; enrolment stopped early because of COVID-19) | 9.6 mg or 3.2 mg per dose, or placebo | Intranasal | Three times daily | 8-week placebo-controlled period, then 56 weeks of follow-up | Primary endpoints (hyperphagia and obsessive-compulsive scores, 9.6 mg versus placebo) improved numerically but not significantly; the 3.2 mg arm showed nominally significant improvements; flushing was the most common adverse event | Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. J Clin Endocrinol Metab. 2023. |
| COMPASS PWS — phase 3 confirmatory trial, nasal spray (NCT06173531)Clinical trial · Randomised, placebo-controlled phase 3 trial | People with Prader-Willi syndrome (n=175) | 3.2 mg, or placebo | Intranasal | Three times daily | 12 weeks | Primary endpoint not met: hyperphagia score changed by -4.8 with carbetocin and -5.1 with placebo (P = 0.79), with no separation on any secondary endpoint | Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome: Results From the Randomized, Placebo-Controlled, Phase 3 COMPASS PWS Study. Clin Ther. 2026. |
Where sources disagree
- Carbetocin is a long-acting oxytocin analog. The postpartum doses are a single 100 mcg injection right after birth; the Prader-Willi doses were milligram amounts by nasal spray. The two are not interchangeable.
- The FDA has not approved carbetocin for any use. The confirmatory COMPASS PWS trial found no benefit over placebo for hyperphagia in Prader-Willi syndrome.