Nefopam

Evidence Level: L5

Predicted Indications: 10

Nefopam

Pharmacist Assessment Report

Nefopam: From Pain Relief (Analgesia) to Immature Cataract

One-Sentence Summary

Nefopam is a centrally acting, non-opioid analgesic that is currently marketed in India as tablets and an injection. The TxGNN model predicts it may be effective for immature cataract, but there are 0 clinical trials and 0 publications for this disease, so the prediction rests on the model score alone. A separate prediction in the same list, lumbar spinal stenosis, has some supporting literature and is covered below.

Quick Overview

Item	Content
Original Indication	Not stated in the licence records (analgesic drug class)
Predicted New Indication	Immature cataract
TxGNN Prediction Score	0.9998
Evidence Level	L5
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 a structured form. Based on the compiled information, nefopam inhibits serotonin, norepinephrine and dopamine reuptake and modulates voltage-gated sodium and calcium channels. These actions fit pain relief.

No mechanistic link to lens opacification has been established. The score of 0.9998 comes from the TxGNN model (deep learning) and is shared by most cataract subtypes in the list (immature, mature, craniostenosis, type 2 diabetes-associated, tetanic, cortical, nuclear senile and senile cataract). Diabetic cataract scores 0.9997. This pattern may reflect similarities the model learned between related diseases, not biological evidence. The prediction should be treated as a hypothesis without supporting evidence.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Another Prediction with Literature: Lumbar Spinal Stenosis

Lumbar spinal stenosis (TxGNN score 0.9997) is the only predicted indication in this list with published studies. The studies concern pain control around spine surgery, not treatment of the disease itself, and nefopam is already an analgesic. No registered clinical trials were provided. The evidence level is set conservatively at L3, and the recommendation is “Research Question”.

PMID	Year	Type	Journal	Key Findings
38068520	2023	Randomized, double-blind study	J Clin Med	73 patients having spine surgery for lumbar spinal stenosis received nefopam 20 mg or saline. The study looked at dysesthesia, postoperative pain and satisfaction.
41937571	2026	Randomized, double-blind, placebo-controlled trial	Asian Spine J	Opioid-sparing effect of postoperative continuous intravenous nefopam in multilevel degenerative lumbar spinal fusion.
31166320	2019	Clinical study or review (design to be confirmed)	Zh Vopr Neirokhir Im N N Burdenko	Compared multimodal analgesia regimens during spinal stenosis surgery and their effect on the rate of failed back surgery syndrome.
25535527	2014	Case report	J Korean Neurosurg Soc	Status epilepticus after nefopam in a 71-year-old man admitted for lumbar spinal stenosis surgery.

India Market Information

Authorization Number	Product Name	Dosage Form	Manufacturer
150449	Nefodol Tablet	Strip of 10 tablets	Medley Pharmaceuticals
151496	Nefosar 20mg Injection	Ampoule of 1 ml injection	Abbott
150485	Nefosar Tablet	Strip of 10 tablets	Abbott

All three licences are valid products, available in oral and injectable forms. The licence records do not include approved indication text.

Review correction (2026-11-06): Originally stated: “All three licences are valid single-ingredient products, available in oral and injectable forms.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Seizure risk: A published case report describes status epilepticus after nefopam (PMID 25535527). Seizure-risk guardrails would be needed in any further development.
No drug interactions were found in the queried data, and no disease contraindications were recorded in the knowledge graph.

For other safety information, please refer to the package insert.

Conclusion and Next Steps

Decision: Hold

Rationale: The immature cataract prediction has no clinical trials and no publications, and no plausible mechanism links nefopam to lens opacity. The identical score across the cataract cluster points to a model artifact. The evidence level is L5.

To proceed, the following is needed:

Mechanistic or preclinical evidence linking nefopam to lens biology, before any further work on the cataract predictions
The package insert warnings and contraindications from the India licence documents
The approved indication text for the three licences
If the lumbar spinal stenosis question is pursued, confirmation of the study designs and a review of seizure-risk safety

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
2026-11-06	Removed: “single-ingredient”	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.