Mefenamic Acid
| Evidence Level: L2 | Predicted Indications: 6 |
Table of Contents
Mefenamic Acid: Headache disorder
One-Sentence Summary
Mefenamic acid is a non-steroidal anti-inflammatory drug that blocks prostaglandin synthesis and is marketed in India as a single-ingredient product. The TxGNN model predicts it may be useful for headache disorder. There are no registered clinical trials, but 19 publications were compiled, including three small randomized double-blind trials in migraine, a subtype of headache disorder.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Headache disorder |
| TxGNN Prediction Score | 0.9964 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the compiled data. The literature describes mefenamic acid as an inhibitor of prostaglandin synthesis and action.
Prostaglandins are implicated in some headache types, particularly menstrually related headache and migraine. This gives a plausible pharmacological link between the drug and headache disorder. Several of the studies below test it directly in migraine patients, with mixed results. They suggest benefit for acute attack pain, for menstrual migraine, and for reducing attack frequency in prophylaxis.
The evidence is small-scale and dated. Long-term use also carries safety concerns, including medication-overuse headache and gut injury, which weigh against routine prophylactic use.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6347393 | 1983 | RCT | Cephalalgia | Double-blind crossover in 40 migraine patients comparing mefenamic acid 500 mg with paracetamol 500 mg over six attacks, with metoclopramide given in all attacks |
| 3524092 | 1986 | RCT | Acta Neurol Scand | Double-blind crossover in 29 patients. Mefenamic acid and propranolol both reduced attack frequency and total duration versus placebo, with no effect on average severity or duration |
| 10799353 | 2000 | RCT | Eur J Med Res | Placebo-controlled study in 24 women with menstrual migraine without aura, treated over two menstrual cycles |
| 22529203 | 2012 | Guideline | Neurology | American Academy of Neurology and American Headache Society update on NSAIDs and complementary treatments for episodic migraine prevention |
| 18427072 | 2008 | Evidence-based review | Neurology | Systematic review and meta-analysis of therapy trials for acute and short-term preventive treatment of menstrually related migraine |
| 20836574 | 2010 | Review | Drugs | Prevention and treatment of menstrual migraine |
| 40265504 | 2025 | Review | Curr Opin Neurol | Update on the clinical course and management of migraine in women |
| 1495823 | 1992 | Review | Pathol Biol | Review of controlled NSAID studies in migraine attacks and prophylaxis, including mefenamic acid |
| 8749241 | 1995 | Review | Cephalalgia | Analgesics and NSAIDs in acute migraine attacks, usually combined with an antiemetic |
| 29095288 | 2017 | Case series (safety) | Medicine | Severe enteropathy with villous atrophy in prolonged mefenamic acid users |
India Market Information
The data lists 20 valid single-ingredient licences. The records may be partial, so the list below is not exhaustive. The five shown are the main ones:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 119923 | Kiamol MF Oral Suspension | 60 ml bottle, oral suspension | Not stated |
| 146000 | Mefhil Syrup | 60 ml bottle, syrup | Not stated |
| 135567 | Mefril MF 250mg/325mg Tablet | Strip of 10 tablets | Not stated |
| 133543 | Mefkind Forte Tablet | Strip of 10 tablets | Not stated |
| 210252 | StayHappi Mefenamic Acid 250mg Tablet | Strip of 10 tablets | Not stated |
Safety Considerations
- Literature-reported risks:
- Prolonged use has been linked to severe enteropathy with villous atrophy.
- NSAIDs, including mefenamic acid, are associated with medication-overuse headache.
- Analgesic overuse in chronic headache patients has been linked to chronic renal disease.
- An acute tubulointerstitial nephritis case was reported in a child given NSAIDs including mefenamic acid.
- Drug Interactions: 195 interactions were identified. Moderate-level examples include:
- acetylsalicylic acid
- metformin
- chlorpropamide
- corticosteroids (hydrocortisone, dexamethasone, betamethasone, budesonide, triamcinolone)
- mesalazine and balsalazide
- aprepitant
Minor-level examples include famotidine, ranitidine and cimetidine.
Please refer to the package insert for full warnings and contraindications, as they are not available in the compiled data.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Small randomized double-blind trials of mefenamic acid exist in migraine, a subtype of headache disorder. They date from 1983, 1986 and 2000 and include a placebo-controlled menstrual migraine study. There is no phase 3 programme and no registered modern trial, so the evidence level is L2. The drug is already marketed in India, but the dated, small-scale evidence and the risks of long-term use call for careful limits.
To proceed, the following is needed:
- A modern, adequately powered randomized trial in a defined headache population, such as menstrual migraine
- Limits on treatment duration, with monitoring for medication-overuse headache and gastrointestinal and renal toxicity
- Package insert warnings and contraindications, and mechanism-of-action data
- Review of interactions, especially with aspirin, corticosteroids and other drugs that raise gastrointestinal or renal risk
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.