Nitroprusside
| Evidence Level: L4 | Predicted Indications: 9 |
Table of Contents
Nitroprusside: From Hypertensive Emergencies to Migraine Disorder
One-Sentence Summary
Nitroprusside is an intravenous nitric oxide (NO) donor, marketed in India as a 50 mg injection. The approved indication text is not recorded in the data compiled for this report. The TxGNN model predicts it may be effective for migraine disorder, but there are no clinical trials and the retrieved literature is mostly preclinical or observational. The literature also suggests NO donors tend to provoke migraine rather than relieve it, so this top-ranked prediction is not supported mechanistically.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the licence data |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L4 |
| India Market Status | Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data |
| Number of Listed Products | 3 (valid: 3) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the drug record. From general pharmacology, nitroprusside releases nitric oxide, which activates soluble guanylate cyclase, raises cGMP and relaxes vascular smooth muscle.
The NO/cGMP and CGRP pathways are central to migraine biology. However, the direction of the link argues against benefit. NO donors such as nitroglycerin are established experimental migraine triggers, and sodium nitroprusside is used to induce migraine-like behaviour in the mouse models in the retrieved studies. The score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
For context, other predictions in the ranking fit better. Pulmonary hypertension (score 0.9998, evidence level L3) is mechanistically coherent with vasodilation and is supported by clinical studies and reviews. Pulmonary use is limited by systemic hypotension, ventilation-perfusion mismatch and cyanide toxicity. Hair-loss conditions (alopecia, hypotrichosis), kyphoscoliotic heart disease and benign prostatic hyperplasia have little or no direct evidence.
Clinical Trial Evidence
Currently no related clinical trials are registered for migraine disorder.
For the more plausible prediction, pulmonary hypertension, one trial was found but is only loosely relevant:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02966665 | Phase 1 | Recruiting | 420 | Vascular function and exercise rehabilitation in hypertension. Nitroprusside is likely used only as a vascular probe, and the study is not specific to pulmonary hypertension. |
Literature Evidence
Migraine disorder (selected from 20 retrieved papers; none are RCTs):
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21122149 | 2010 | Cross-sectional | BMC Neurol | Tests whether endothelial dysfunction and NO release are impaired in migraine patients |
| 19528518 | 2009 | Cohort | Neurology | Vascular smooth muscle cell dysfunction in migraine patients |
| 18384419 | 2008 | Cohort | Cephalalgia | Compares CGRP and NO responses in the skin microcirculation of migraine and control subjects |
| 16396667 | 2006 | Cohort | Cephalalgia | Forearm blood flow responses to nitroprusside and CGRP in 10 migraine patients and 10 controls |
| 39988876 | 2025 | Preclinical | Cephalalgia | CBD and THC reduce migraine-like behaviour in mice, including a nitroprusside-triggered model |
| 36697259 | 2023 | Preclinical | J Neurosci | Peroxynitrite contributes to NO-donor-triggered migraine-like responses in mice |
| 23152076 | 2013 | Preclinical | Eur J Pain | St. John’s wort relieves pain in a mouse migraine model induced by NO donors |
| 6745825 | 1984 | Case series | Fortschr Med | Nitroprusside treated ergotamine-induced ergotism (arterial spasm) in 12 cases, a complication of migraine therapy rather than migraine itself |
Pulmonary hypertension (the more plausible alternative):
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15725144 | 2005 | Clinical study | J Card Surg | Compared inhaled prostacyclin, inhaled NO and IV nitroprusside for pulmonary hypertension after mitral valve replacement |
| 32176355 | 2020 | Systematic review | J Card Surg | Nitroprusside versus nicardipine for hypertension after cardiac surgery |
| 42572609 | 2026 | Review | JHLT Open | Inhaled pulmonary vasodilators in the perioperative setting. Nitroprusside lacks pulmonary selectivity. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 151420 | Nipress 50mg Injection (Samarth Life Sciences Pvt Ltd) | Vial of 1 injection | Not recorded |
| 177604 | Pruside 50mg Injection (Troikaa Pharmaceuticals Ltd) | Vial of 1 injection | Not recorded |
| 152581 | Nitoside 50mg Injection (Neon Laboratories Ltd) | Vial of 1 injection | Not recorded |
Safety Considerations
- Drug Interactions: 58 interactions were identified, all rated Moderate in the sources that were checked. Examples include corticosteroids (hydrocortisone, dexamethasone, prednisone, prednisolone, budesonide), SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin), morphine, opium, bupropion, promethazine, amifostine, dronabinol and nabilone.
For warnings and contraindications, please refer to the package insert. Known concerns for the route and drug class include systemic hypotension and cyanide toxicity.
Conclusion and Next Steps
Decision: Hold
Rationale: The migraine prediction has no clinical trials and only preclinical or observational support, and the evidence suggests NO donors trigger migraine rather than treat it. The high TxGNN score is not backed by clinical evidence. If any indication is pursued, pulmonary hypertension has the most coherent mechanism and clinical literature, though inhaled delivery remains investigational.
To proceed, the following is needed:
- The package insert (warnings, contraindications and approved indications) from the three India registrations
- Mechanism of action data for the record
- A review of why the TxGNN migraine prediction conflicts with the known pro-migraine effect of NO donors
- If pulmonary hypertension is pursued, a focused evidence review and a plan for delivery route, haemodynamic monitoring and cyanide-toxicity risk
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.