Hydromorphone
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Hydromorphone
Hydromorphone: Pharyngitis
One-Sentence Summary
Hydromorphone is an opioid analgesic. The scores on this page come from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. The TxGNN model’s top-ranked prediction is pharyngitis, supported by 3 clinical trials that are all about post-tonsillectomy pain rather than pharyngitis itself, and no publications. The best-supported alternative is headache disorder, with 1 completed Phase 4 RCT and 17 publications. Even there, guidelines caution against opioid use.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Pharyngitis |
| TxGNN Prediction Score | 0.9981 |
| Evidence Level | L5 (indirect, symptomatic evidence only) |
| Canada Market Status | Marketed (marketed DINs on record: at least 19; dormant: 1) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available from the compiled data. Hydromorphone is, however, a well-known mu-opioid agonist with central analgesic effects. For pharyngitis, any plausible benefit would be limited to symptomatic pain relief. It has no anti-infective or anti-inflammatory action against the underlying cause.
The link to the original indications (common cold, nasopharyngitis) is that all are upper airway conditions with sore throat as a symptom. The linked trials involve post-tonsillectomy pain, a surgical pain model, so the connection to pharyngitis is indirect. Opioids also suppress cough and may be unsuitable for upper airway inflammation.
The other predictions are weaker. Allergic urticaria is argued against by opioid-induced histamine release. Nasal cavity disease, acute laryngopharyngitis and trigeminal autonomic cephalalgia have no trials or publications. Headache disorder (acute migraine) is the only alternative with direct hydromorphone trial data. The score is also a computational prediction only.
Clinical Trial Evidence
Pharyngitis (top prediction)
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04230681 | Early Phase 1 | Completed | 189 | Hydromorphone vs fentanyl for pain control in children after tonsillectomy/adenotonsillectomy (surgical pain, not pharyngitis) |
| NCT05244226 | Phase 2 | Completed | 66 | Methadone vs short-acting opioids (fentanyl/hydromorphone) for pediatric post-tonsillectomy pain; class-level context only |
| NCT06576830 | Phase 4 | Recruiting | 440 | Intraoperative methadone vs short-acting opioids in pediatric tonsillectomy; no results yet |
Headache disorder (best-supported alternative)
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02389829 | Phase 4 | Completed | 127 | Hydromorphone vs prochlorperazine + diphenhydramine for acute migraine in the emergency department |
Literature Evidence
No literature is available for pharyngitis. The publications below relate to headache disorder.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29046364 | 2017 | RCT | Neurology | IV prochlorperazine + diphenhydramine vs IV hydromorphone for migraine in the emergency department |
| 34363617 | 2021 | RCT (post hoc) | Headache | Impact of hydromorphone vs prochlorperazine on migraine-associated symptoms |
| 17981511 | 2008 | Cohort | J Pain | Metoclopramide vs hydromorphone for emergency department migraine treatment |
| 41321235 | 2026 | Guideline | Headache | Updated American Headache Society guidance on parenteral therapies for acute migraine in the emergency department |
| 27300483 | 2016 | Guideline | Headache | Original American Headache Society evidence assessment of parenteral pharmacotherapies for acute migraine |
| 29461426 | 2018 | Review | Curr Opin Neurol | Review of emergency management of primary headache |
| 39924451 | 2025 | Systematic review | Addiction | Relative risks of adverse effects across opioid agonist treatments |
| 29516486 | 2018 | Cohort | Headache | Opioid “likeability” and “feeling good” not associated with return visits among migraine patients given IV hydromorphone |
| 24948146 | 2015 | Survey analysis | Cephalalgia | Current migraine management in US emergency departments |
| 32781832 | 2020 | Database analysis | Cephalalgia | Patterns and predictors of opioid use among migraine patients in emergency departments |
Canada Market Information
The licence records compiled for this report have no dosage form, manufacturer or approved indication text. A selection of the 20 valid single-ingredient licences:
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 00125083 | DILAUDID | Not listed | Not listed |
| 00786543 | DILAUDID | Not listed | Not listed |
| 02364123 | APO-HYDROMORPHONE | Not listed | Not listed |
| 02359502 | HYDROMORPH CONTIN | Not listed | Not listed |
| 02469413 | HYDROMORPHONE HYDROCHLORIDE INJECTION HP 50 | Not listed | Not listed |
Other licences cover further injection, tablet and controlled-release capsule products (6, 12 and 24 mg).
Safety Considerations
Contraindications (from knowledge graph drug-disease edges, not label text):
- Hepatic and renal: liver failure, liver disease, kidney disease
- Respiratory and cardiac: respiratory failure, sudden cardiac arrest, heart conduction disease, hypotensive disorder
- Neurological: epilepsy
- Endocrine: hypothyroidism, myxedema, congenital hypothyroidism, Addison disease, adrenal insufficiency and related adrenal disorders, congenital adrenal hyperplasia
- Gastrointestinal and urinary: inflammatory bowel disease, ulcerative colitis, constipation disorder, gallbladder disease, pyoureter, benign prostatic hyperplasia
- Substance use: substance-related disorder, substance abuse/dependence, drug dependence
- Other: butyrylcholinesterase deficiency
Drug Interactions: 100 interactions were found. The major ones include:
- Major: alvimopan, bupropion, morphine, naltrexone
- Moderate (examples): anticholinergics (hyoscyamine, atropine, glycopyrronium, dicyclomine, trospium), loperamide, naloxone, eluxadoline, cimetidine, dronabinol, nabilone
Package insert warnings and contraindications for the Canadian products have not yet been retrieved. Please refer to the package insert for label safety information.
Additional caution: For migraine, American Headache Society guidance generally discourages opioids because of poorer outcomes, recurrence and dependence risk.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The top prediction (pharyngitis) rests only on post-tonsillectomy pain trials, which are a surgical pain model, and the effect would be symptomatic at best. The only direct evidence is in acute migraine, where guidelines discourage opioids. The safety profile also carries a heavy burden of contraindications and interactions.
To proceed, the following is needed:
- Mechanism of action data
- Health Canada package insert warnings and contraindications (a blocking gap for safety screening)
- Approved indication text, dosage forms and routes for the Canadian licences
- Pharyngitis-specific clinical evidence, rather than post-surgical pain data
- A risk-benefit assessment against non-opioid alternatives, with dependence risk, if the migraine direction is pursued
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.