Reproductive & sexual health
Carbetocin
A long-acting oxytocin analogue approved in many countries — but not the US — to prevent uterine atony after delivery.
- How settled this rating is:
- moderate confidence in the current evidence rating
- Routes studied:
- Intravenous, Intramuscular
- Also known as:
- Duratocin, Pabal
- Last reviewed:
- 2026-08-23
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Evidence passport
Carbetocin
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
- Evidence level
- L4Good human trials
- Confidence
- Moderate confidence in rating
- Regulatory status
- Approved in some countries only · See jurisdiction details
- Development status
- Approved
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
- Evidence base
- Includes human studies
- Furthest established stage
- Approved
- Human research maturity
- Approved regionally; long clinical use
- Source curation
- Sources fully curated
Routes recorded
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
How to read these scores
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
- Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
- Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
- Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
- Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
- Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: Approved regionally; long clinical use
Routes & formulations
Studied / approved routes
Given as a single injection (IV or IM depending on the national label) in the peripartum setting.
Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.
Peptide lifecycle
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
Approved through national procedures in many markets; no US development programme is established in the curated record.
What it is
A modified oxytocin analogue engineered for longer action, used where a sustained uterotonic effect is wanted after delivery.
What people claim
- Prevents uterine atony and excessive bleeding after caesarean delivery
What the evidence actually says
Randomised trials support its uterotonic role in the settings covered by national labels. It is a useful illustration that approval is regional: widely used in Europe and elsewhere, absent from the US market.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Oxytocin evidence profile
The natural nonapeptide hormone of labour and lactation, long approved as an IV/IM obstetric medicine.
- Compare
Compare Carbetocin vs Oxytocin evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Checked claim
Claim review: “Oxytocin nasal sprays sold online carry the same evidence as medical Pitocin.”
A closely related claim we have graded, from Routes & formulations.
- Context
Safety Centre
What approved, investigational and unapproved actually mean for documented human safety.
Human evidence
- Randomised controlled trials versus oxytocin in caesarean and postpartum settings.
- National regulatory assessments across multiple markets.
Preclinical evidence
- Oxytocin-analogue receptor pharmacology with extended duration of action.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
- Oxytocin-receptor agonism with slower degradation produces a prolonged uterotonic effect.
Safety and unknowns
- Adverse-effect profile is broadly similar to oxytocin within labelled use.
- Not interchangeable with unregulated oxytocin-like research products.
Cancer relevance
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
No concern identified
Regulatory status
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Named regulators: National authorisations (EU member states and other markets)
Authorised in numerous countries through national approvals, including across EU member states via national procedures, for prevention of uterine atony and postpartum haemorrhage in specified obstetric settings. Not FDA-approved; EMA material describes nationally authorised products rather than a centralised EU approval.
Evidence grade
Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.
What would change our rating?
- Not applicable at this evidence tier.
References and sources
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
- Last editorial review
- 2026-08-23
- Recently reviewed · 54 days ago
- Linked curated sources
- 2
- Sources still pending
- 0
- External specialist reviews
- 0
- None recorded for this profile
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
- Regulatory / labelEMA PSUSA: carbetocin — list of nationally authorised medicinal products
- Regulatory / labelEMA CHMP monthly report, May 2006 (carbetocin opinion)
Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.
Evidence change history
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
No recorded changes yet. Baseline position set on 2026-08-23.