Meclizine

Evidence Level: L5

Predicted Indications: 6

Meclizine

Pharmacist Assessment Report

Meclizine: From Central Nervous System Vertigo and Motion Sickness to Allergic Urticaria

One-Sentence Summary

Meclizine is a first-generation antihistamine, originally used to treat vertigo of central nervous system origin and motion sickness. The TxGNN model predicts it may be effective for Allergic Urticaria, but no clinical trials and no publications were found to support this direction, so the prediction rests on model output and drug-class reasoning alone.

Quick Overview

Item	Content
Original Indication	Central nervous system origin vertigo; motion sickness (the licence records contain no approved indication text)
Predicted New Indication	Allergic urticaria
TxGNN Prediction Score	0.9967
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (16 of 16) – CDSCO approval status is not included in this data
Number of Listed Products	16 (valid: 16)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not currently available. Based on known information, meclizine is a first-generation piperazine H1-antihistamine with anticholinergic activity. Its efficacy in vertigo and motion sickness is established, and mechanistically it may be applicable to histamine-mediated conditions such as urticaria.

H1-antihistamines are the standard first-line therapy for urticaria, so the mechanistic link is plausible. However, this link rests on drug-class knowledge and the TxGNN prediction, not on any meclizine-specific data supplied for this report. Better-characterized antihistamines are already established for this condition, and non-sedating second-generation agents are generally preferred. The incremental value of meclizine is therefore unclear. Its sedation and anticholinergic burden are also relevant.

Other Predicted Indications

Rank	Predicted Indication	TxGNN Score	Evidence Level	Comment
2	Common cold	0.9949	L5	Possible symptomatic relief only (rhinorrhoea, sneezing); not disease-modifying
3	Nasal cavity disease	0.9948	L5	Term too broad to test; a specific condition must be defined first
4	Pharyngitis	0.9945	L5	No antimicrobial or anti-inflammatory action; at most symptom relief
5	Acute laryngopharyngitis	0.9937	L5	Anticholinergic drying could worsen throat irritation
6	Cold urticaria	0.9922	L5	Most direct mechanistic rationale; flagged as a research question

India Market Information

Sixteen valid registrations exist and none are cancelled. The records contain no approved indication text. The five main authorizations are listed below.

Review correction (2026-11-06): Originally stated: “Sixteen valid single-ingredient registrations exist and none are cancelled.” 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.

Authorization Number	Product Name	Dosage Form	Approved Indication
58351	Diligan 25 Tablet (Dr Reddy’s Laboratories Ltd)	Strip of 15 tablets	Not stated
60901	Diligan 50mg Tablet (Dr Reddy’s Laboratories Ltd)	Strip of 15 tablets	Not stated
30704	Biozine 25mg/50mg Tablet (Remedial Healthcare)	Strip of 10 tablets	Not stated
94575	Gladvert 25mg Tablet (Gladstone Pharma India Pvt Ltd)	Strip of 15 tablets	Not stated
135625	Meclisafe 50mg/5mg Tablet SR (Pfleger Healthcare Pvt Ltd)	Strip of 10 tablets SR	Not stated

All products are oral tablets, including sustained-release forms.

Safety Considerations

Contraindications (from the knowledge graph, not label text): benign prostatic hyperplasia, angle-closure (closed-angle) glaucoma, pyloric stenosis, and bladder neck obstruction. These are consistent with the drug’s anticholinergic activity.
Drug Interactions: 252 interactions are recorded. Most are Moderate, mainly with other anticholinergic or antispasmodic agents (hyoscyamine, atropine, glycopyrronium, dicyclomine, trospium, clidinium, mepenzolate, methscopolamine), opioids and antidiarrhoeals (morphine, opium, loperamide, eluxadoline), and others such as metoclopramide, nabilone, and eliglustat. Two Major interactions are listed: potassium citrate and potassium chloride.
Other: Sedation and anticholinergic burden are relevant, particularly in combination with the agents above.

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

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by a high model score and class-level pharmacology, with no clinical trials or literature (Evidence Level L5). Established, better-tolerated antihistamines already exist for urticaria, and the package insert safety information was not available.

To proceed, the following is needed:

Package insert warnings and contraindications from the India regulatory source (currently a blocking gap for safety screening)
Detailed mechanism of action data from DrugBank
A literature search for any meclizine data in allergic, chronic, or physical (including cold) urticaria. Cold urticaria is the best-supported candidate for follow-up.
A comparison against second-generation antihistamines to determine whether meclizine adds value
A specific condition definition if “nasal cavity disease” is to be pursued

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.