Benzydamine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Benzydamine

Active ingredient · 5 therapeutic classes

GB MHRA

Drug class: Other Antiinflammatory and Antirheumatic Agents, Non-Steroids
Availability: See label
Markets covered: 1
Products on record: 31

M01AXOther Antiinflammatory and Antirheumatic Agents, Non-Steroids A01ADOther Agents For Local Oral Treatment G02CCAntiinflammatory Products For Vaginal Administration M02AAAntiinflammatory Preparations, Non-Steroids For Topical Use R02AXOther Throat Preparations

Overview

Benzydamine is an active pharmaceutical ingredient in the Other Antiinflammatory and Antirheumatic Agents, Non-Steroids group (M01AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	31	May 29, 2026

GBUnited Kingdom· MHRA

31 products

Uses

GBOfficial regulatory label· revised July 4, 2025[1]

Difflam is indicated in adults and children over 6 years of age, for symptomatic local treatment for the relief of pain and irritation of mouth and throat.

How to take

Sources & citations

[1]MHRA (UK) · PL463020097 · revised July 4, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised July 4, 2025[1]

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness The following rate values have been used: Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000), not known (cannot be estimated from the available data).
System-Organ Class Frequency Undesirable effect Immune system disorders Not Known Anaphylactic reaction, Hypersensitivity reaction Respiratory, thoracic, and mediastinal disorders Very rare Laryngospasm Rare Burning mouth, Dry mouth Gastrointestinal Disorders Not known Hypoaesthesia oral Uncommon PhotosensitivitySkin and subcutaneous tissue disorders Very rare Angioedema Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised July 4, 2025[1]

Benzydamine use is not advisable in patient with hypersensitivity to salicylic acid or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.
In a minority of patients, buccal/pharyngeal ulceration may be caused by serious disease processes. Patients whose symptoms worsen or do not improve within 3 days, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate.
Difflam contains: - Isomalt: patients with rare hereditary problems of fructose intolerance should not take this medicine. - Sunset yellow (E 110): may cause allergic reactions. - Fragrance with Citral, Citronellol, d-Limonene, Geraniol and Linalool.
These may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations