Hexetidine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 6, 2026🚩 Report this page

Hexetidine

Active ingredient · 2 therapeutic classes

Sold as ORALDENE · ORALDENE ICEMINT

GB MHRA

Drug class: Other Antiinfectives and Antiseptics
Availability: See label
Markets covered: 1
Products on record: 2

G01AXOther Antiinfectives and Antiseptics A01ABAntiinfectives and Antiseptics For Local Oral Treatment

Overview

Hexetidine is an active pharmaceutical ingredient in the Other Antiinfectives and Antiseptics group (G01AX). 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	2	March 6, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised March 6, 2026[1]

ORALDENE is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE is also of value in the alleviation of halitosis and pre- and post-dental surgery.

How to take

Sources & citations

[1]MHRA (UK) · PL155130067 · revised March 6, 2026

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 March 6, 2026[1]

ORALDENE is generally very well tolerated with a low potential for causing irritation, or sensitisation reactions. Prolonged use of ORALDENE is also well tolerated. Patch testing with of hexetidine containing ointment was negative for irritation or sensitisation potential.
Adverse drug reactions (ADRs) identified during post-marketing experience with hexetidine are included in the tables below.
The frequencies are provided according to the following convention:
Very common 1/10 Common 1/100 and <1/10 Uncommon 1/1,000 and <1/100 Rare 1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs identified during post-marketing experience are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, when available or 2) when incidence is unavailable, frequency category is listed as Not known.
Table 1 Adverse Drug Reactions Identified During Post-Marketing Experience with Hexetidine by Frequency Category Estimated from Clinical Trials or Epidemiology Studies: Immune System Disorders Not known Hypersensitivity reactions*; Angioedema Nervous System Disorders Very rare Not known Dysgeusia Ageusia Respiratory, Thoracic and Mediastinal Disorders Not known Cough; Dyspnoea** Gastrointestinal Disorders Not known Dry mouth; Dysphagia; Nausea; Salivary gland enlargement; Vomiting General Disorders and Administration Site Conditions Very rare Not known Transient anaesthesia Application site reactions*** *Inclusion of the PT of hypersensitivity reactions was based on cases reporting the following additional MedDRA PTs: Hypersensitivity and Urticaria.
** Observed in the context of Hypersensitivity. *** Inclusion of the PT of Application site reactions was based on cases reporting multiple MedDRA PTs. These included Mouth and Throat mucosa irritation, Paraesthesia oral, Tongue discolouration, Tooth discolouration, Inflammation, Blistering and Ulceration.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised March 6, 2026[1]

ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed. 8 mg of alcohol (ethanol) in each 15 ml. The amount in 15 ml of this medicine is equivalent to less than 15 ml beer or 6 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Azorubine (E122) may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per 15 ml, that is to say essentially ‘sodium-free’. Not suitable for persistent symptoms.

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