Ergometrine

Evidence Level: L5

Predicted Indications: 10

Ergometrine

Pharmacist Assessment Report

Ergometrine: From Uterotonic Use to hypertrichosis (disease)

One-Sentence Summary

Ergometrine (ergonovine) is an ergot alkaloid uterotonic. It is listed with one Canadian licence (ERGONOVINE MALEATE INJECTION USP), but the licence record contains no approved indication text. The TxGNN model’s top-ranked prediction is hypertrichosis, but no clinical trials and no publications support it, so this is a model-only (L5) signal. Among the ten predictions, only migraine disorder has indirectly related literature, and none of it studies ergometrine as a treatment.

Quick Overview

Item	Content
Original Indication	Not stated in the licence record
Predicted New Indication	Hypertrichosis
TxGNN Prediction Score	0.9996
Evidence Level	L5
Canada Market Status	Marketed (marketed DINs: 1 of 1)
Number of DINs	1 (marketed: 1)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known pharmacology, ergometrine is an ergot alkaloid that acts on alpha-adrenergic, serotonergic and dopaminergic receptors and is used as a uterotonic.

For hypertrichosis, no plausible mechanistic link was identified. Hair growth is not a recognised target of this receptor pharmacology, and the high score (rank 1205 overall) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. No trial or publication supports it.

The other predictions do not fare better:

Ambras-type congenital hypertrichosis, nephrogenic syndrome of inappropriate antidiuresis, malformation syndromes (odontal/periodontal, Dandy-Walker), genetic hair shaft abnormality, leprosy: no mechanistic rationale and no evidence.
Migraine disorder: biologically plausible, because related ergots (ergotamine, dihydroergotamine, methysergide) are used in migraine through serotonergic and vasoconstrictive effects. However, the evidence concerns related compounds and one case report, not ergometrine itself, and that case report describes a vasoconstrictive safety risk.
Migraine with brainstem aura: vasoconstrictive ergots carry ischaemic risk in this setting. Only a case report and a historical review were retrieved.
Pulmonary hypertension: ergometrine is more likely to cause harm, because it can raise pulmonary vascular resistance. This is a safety signal, not an opportunity.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

No literature is available for the top-ranked prediction (hypertrichosis). The literature below was retrieved for other predictions and is indirect.

PMID	Year	Type	Journal	Key Findings
9793694	1998	Review	Cephalalgia	Methysergide, an ergometrine derivative, is used for migraine prophylaxis (5-HT receptor activity); relates to a related drug, not ergometrine
10971665	2000	Case report	Headache	Postpartum cerebral angiopathy in a woman with chronic migraine with aura; vasoconstrictive safety concern
41844474	2026	Review	Int J Obstet Anesth	Focused review of uterotonic use in pregnant patients with cardiac disease, including pulmonary hypertension
22731893	2012	Review	Anaesthesia	Management issues in pre-eclampsia for anaesthetists; obstetric context, not therapeutic benefit
20509463	2009	Review (historical)	J R Coll Physicians Edinb	History of ergot of rye, 1900–1940
3214444	1988	Preclinical (animal)	Arzneimittel-Forschung	Cardiovascular effects of nilvadipine in animals; unrelated to ergometrine

Canada Market Information

DIN	Product Name	Dosage Form	Approved Indication
02441241	ERGONOVINE MALEATE INJECTION USP	Not stated	Not stated

Safety Considerations

Contraindications recorded in the knowledge graph (drug–disease relations, not label text): hypertensive disorder, hypertension, epilepsy, kidney disease, pyoureter, liver disease, gallbladder disease, stroke disorder, cerebrovascular disorder, susceptibility to ischaemic stroke (obsolete term), cerebral infarction, arteriosclerosis obliterans, HELLP syndrome.
Drug interactions: 83 interactions were found in total. Major-level examples among those listed: isometheptene, epinephrine (including topical), ephedrine, lorcaserin, clarithromycin, cobicistat. Moderate-level examples: doxycycline, tetracycline, minocycline, aprepitant, dexamethasone, cimetidine, miconazole, clotrimazole.
Vasoconstrictive risk: the retrieved literature flags cerebral angiopathy risk after postpartum ergot exposure and caution in cardiac disease and pulmonary hypertension.

Package insert warnings and contraindications were not available for this report; please refer to the Health Canada package insert.

Conclusion and Next Steps

Decision: Hold

Rationale: The top prediction (hypertrichosis) rests only on a TxGNN model (deep learning) score, which may reflect similarities the model learned between related diseases, not biological evidence, with no trials, no literature and no plausible mechanism. The one biologically plausible direction, migraine, is supported only by evidence on related ergots and a case report that raises a safety concern, so no prediction reaches the evidence level needed to proceed. The migraine predictions are not backed by a study of ergometrine in that disease, so they are also treated as L5 under the evidence rules.

To proceed, the following is needed:

Health Canada package insert warnings, contraindications, dosage form and approved indication text (currently a blocking gap)
Mechanism-of-action data from DrugBank
For migraine, if pursued: a targeted literature review of ergometrine itself and a vascular safety assessment
No further work is suggested for the other predicted diseases without new supporting evidence
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.