Pregabalin

Evidence Level: L5

Predicted Indications: 6

Pregabalin

Pharmacist Assessment Report

Pregabalin: Tendinitis

One-Sentence Summary

Pregabalin is a calcium-channel-modulating drug originally used for postherpetic neuralgia, fibromyalgia, myofascial pain syndrome and anxiety disorder. The TxGNN model’s top-ranked prediction is tendinitis, but that prediction has no direct supporting evidence. The best-supported candidate is Migraine Disorder, with 2 clinical trials (one withdrawn, one indirect) and 19 publications, including several pediatric randomized trials. This report therefore focuses on migraine disorder as the most evidence-backed candidate and notes the top-ranked prediction for comparison.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Tendinitis
TxGNN Prediction Score	0.9971
Evidence Level	L5 (migraine disorder)
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	Hold (a research question, not yet ready for a clinical recommendation)

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. From known pharmacology, pregabalin binds the alpha2-delta subunit of voltage-gated calcium channels and reduces release of excitatory neurotransmitters such as glutamate. This is the basis of its use in neuropathic pain, fibromyalgia and anxiety.

Migraine shares features with these conditions: central sensitization, neuronal hyperexcitability and trigeminal nociceptive transmission. Preclinical studies show that pregabalin raises the threshold for cortical spreading depression, the phenomenon underlying migraine aura. It also protects against spreading depolarization in a familial hemiplegic migraine mouse model. This makes a mechanistic link plausible.

The practical evidence is modest. Pediatric randomized trials compared pregabalin with propranolol and with sodium valproate for prophylaxis. Adult randomized evidence is lacking.

For the other predictions, evidence is weaker. Tendinitis, myositis fibrosa, idiopathic granulomatous myositis and inclusion body myositis rest mainly on the model score. The retrieved literature for tendinitis concerns post-surgical analgesia and unrelated case reports, and the single paper for inclusion body myositis is a spurious match. Migraine with brainstem aura has only preclinical and indirect support (L4).

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00447369	Phase 3	Withdrawn	70 (planned)	Randomized blinded crossover comparison of pregabalin vs sodium valproate for migraine prevention. Withdrawn, so no efficacy or safety data
NCT02747940	Phase 4	Completed	200	Brain imaging signatures of chronic pain disorders (chronic migraine and fibromyalgia). A mechanistic study, not a migraine efficacy trial of pregabalin

Literature Evidence

PMID	Year	Type	Journal	Key Findings
37637787	2023	RCT	Iran J Child Neurol	Pregabalin vs sodium valproate for pediatric migraine prophylaxis
26024701	2015	RCT	Acta Med Iran	Pregabalin vs propranolol for childhood migraine prophylaxis (99 children)
39388181	2024	Network meta-analysis	JAMA Netw Open	Efficacy and safety of preventive medications in pediatric migraine
23797675	2013	Systematic review	Cochrane Database Syst Rev	Gabapentin or pregabalin for prophylaxis of episodic migraine in adults
21479703	2011	Follow-up study	J Headache Pain	Efficacy and tolerability of pregabalin as migraine preventive over 3 months
25669613	2015	Clinical study	Int J Clin Pharmacol Ther	Effect of pregabalin on central sensitization and allodynia in migraine
30880369	2019	Review	Curr Treat Options Neurol	Antiepileptic drugs as preventive migraine therapy
37924146	2023	Preclinical	Mol Brain	Chronic pregabalin protects against spreading depolarization in an FHM-1 model
30001248	2018	Review (adverse effects)	Clin Neuropharmacol	Sexual dysfunction reported with pregabalin, mostly dose related
28223480	2017	Preclinical	PNAS	Pregabalin inhibits cortical spreading depression in vivo

India Market Information

Twenty valid licences are registered, all for single-ingredient products (no combination licences). The licence records contain no approved indication text. Five representative authorizations:

Authorization Number	Product Name	Dosage Form	Approved Indication
174382	Pregalin SR 150 Tablet (Torrent Pharmaceuticals)	Strip of 10 SR tablets	Not stated in records
174572	Pregabid 150 Capsule (Intas Pharmaceuticals)	Strip of 10 capsules	Not stated in records
181350	Preega 150 Tablet (Talent India)	Strip of 10 tablets	Not stated in records
176356	Pregamax-D Capsule (Winmark Pharmaceuticals)	Strip of 10 capsules	Not stated in records
235209	Veintree 50mg Tablet (Zenolia Life Science)	Strip of 10 tablets	Not stated in records

All products are oral (tablets, SR tablets and capsules). Many of the registered products carry “NT” or similar names, suggesting fixed combinations with other agents, although they are classified as single-ingredient in the records.

Safety Considerations

Contraindication signals from the knowledge graph (not label text): anxiety and neurotic disorders, dysthymic disorder, thrombocytopenia, angioedema (including hereditary and ACE-inhibitor-type), myopathy and rhabdomyolysis, impaired renal function, and atrioventricular block. These should be verified against the product label.
Drug interactions: 183 interactions were identified. Major-level interactions include morphine (including liposomal morphine), which is relevant given additive central nervous system and respiratory depression. Moderate-level interactions include pioglitazone, rosiglitazone, troglitazone, difenoxin, diphenoxylate, dronabinol, nabilone, metoclopramide, opium and sibutramine.
Adverse effects noted in the literature: sexual dysfunction (mostly dose related) and sedation.

Please refer to the package insert for full warnings and contraindications, which were not available for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: Migraine disorder has the strongest support among the predictions, with randomized pediatric trials against propranolol and valproate (L2). The top-scoring prediction (tendinitis) and the myositis predictions rest on the model score alone. Package insert safety data are also missing, so safety screening cannot proceed.

Review correction (2026-10-31): Originally stated: “Migraine disorder has the strongest support among the predictions, with randomized pediatric trials against propranolol and valproate (L2). However, the only Phase 3 trial was withdrawn, adult randomized evidence is lacking, and the trials are small.” Removed: it said the product records were cancelled, discontinued, or not current, which did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-10-31). Source: Indian Medicine Dataset.

To proceed, the following is needed:

Package insert warnings and contraindications from the Indian regulatory source (a blocking gap)
Detailed mechanism of action data from DrugBank
Adult randomized controlled trials of pregabalin for migraine prevention
Review of sedation and sexual dysfunction risks, and of the interaction with opioids
Confirmation of the pediatric trial results, and a decision on target population

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-10-31	Removed: “However, the only Phase 3 trial was withdrawn, adult randomized evidence is lacking, and the trials are small”	Corrected	Indian Medicine Dataset

Disclaimer

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