Emedastine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: June 1, 2026🚩 Report this page

Emedastine

Other Antiallergics

Sold as Emadine

EU EMA

Drug class: Other Antiallergics
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Emedastine is an active pharmaceutical ingredient in the Other Antiallergics group (S01GX). 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
EU European Union	EMA	1	June 1, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised June 1, 2026[1]

Symptomatic treatment of seasonal allergic conjunctivitis.

How to take

EUOfficial regulatory label

Sources & citations

[1]European Medicines Agency · EMEA/H/C/000223 · revised June 1, 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

EUOfficial regulatory label· Adverse reactions· revised June 1, 2026[1]

Summary of safety profile In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of Emadine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions.
No serious ophthalmic or systemic adverse drug reactions were reported in the clinical trials. 0% of patients. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies or with post marketing experience.
They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. System Organ Classification Frequency Adverse reaction Psychiatric disorders Uncommon abnormal dreams Nervous system disorders Uncommon headache, sinus headache, dysgeusia Eye disorders Common eye pain, eye pruritus, conjunctival hyperaemia Uncommon corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia Cardiac disorders Not known tachycardia Skin and subcutaneous tissue disorders Uncommon rash 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised June 1, 2026[1]

Ocular corneal infiltrates Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management should be implemented. Excipients Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Since EMADINE contains benzalkonium chloride, close monitoring is required with frequent or prolonged use. In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided.
Patients must be instructed to remove contact lenses prior to the application of EMADINE and wait 15 minutes after instillation of the dose before reinsertion.

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

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations