Epinastine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026

Epinastine

Active ingredient · 2 therapeutic classes

US FDAGB MHRA

Drug class: Other Antihistamines For Systemic Use
Availability: Prescription only
Routes: Ophthalmic
Markets covered: 2
Products on record: 2

R06AXOther Antihistamines For Systemic Use S01GXOther Antiallergics

Overview

Plain-language summary, compiled from the cited regulatory records

Epinastine is a medication classified as an antihistamine for systemic use [1]. It functions as an H1 histamine receptor antagonist [1].

This active ingredient is approved for the prevention of itching associated with allergic conjunctivitis [1]. Allergic conjunctivitis is a condition that can cause discomfort and irritation in the eyes due to allergic reactions.

Epinastine is available under various brand names [1]. The number of adverse event reports for this drug in the past 12 months is not available in the provided data.

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

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	1	March 22, 2025
GB United Kingdom	MHRA	1	May 15, 2026

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised March 22, 2025[1]

1 INDICATIONS AND USAGE Epinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

How to take

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 15, 2026[2]

Treatment of the symptoms of seasonal allergic conjunctivitis.

How to take

GBOfficial regulatory label

Sources & citations

[1]FDA DailyMed · 0d4ee45c-e58f-4b… · revised March 22, 2025 [PDF]
[2]MHRA (UK) · PL410420075 · revised May 15, 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

USOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

6 ADVERSE REACTIONS The most common ocular adverse reactions (incidence occurring in approximately 1% to 10% of epinastine HCl-treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most common non-ocular adverse reactions, occurring in 10% epinastine HCl-treated eyes, were infection (cold symptoms and upper respiratory infections).
gov/medwatch. 1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients.
Some of these reactions were similar to the underlying disease being studied. 2 Postmarketing Experience The following reactions have been identified during postmarketing use of epinastine HCl in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine HCl, or a combination of these factors, include: lacrimation increased.

USOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

5 WARNINGS AND PRECAUTIONS To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. 1 ) Epinastine HCl should not be used to treat contact lens-related irritation. 1 Contamination of Tip and Solution Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Bottle should be kept tightly closed when not in use. 2 Use with Contact Lenses Patients should be advised not to wear a contact lens if their eye is red.
Epinastine HCl ophthalmic solution should not be used to treat contact lens-related irritation. The preservative in epinastine HCl, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of epinastine HCl ophthalmic solution and may be reinserted after 10 minutes following its administration.
3 Topical Ophthalmic Use Only Epinastine HCl ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.

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

Posology The recommended dose for adults is one drop instilled in each affected eye twice daily, during the symptomatic period. There is no experience in clinical studies with the use of Relestat for more than 8 weeks. Elderly Relestat has not been studied in elderly people.
Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that there are no particular safety issues for elderly compared with adult patients. As such, no dosage adjustment is considered to be necessary.
Paediatric population The safety and efficacy in children ≥ 12 years has been established in clinical trials. Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults. The safety and efficacy of Relestat in children aged less than 3 years have not been established.
No data are available. 1. Patients with hepatic impairment Relestat has not been studied in patients with hepatic impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that the incidence of adverse reactions was higher in this group compared with adult patients without hepatic impairment.
The daily dose of a 10 mg epinastine hydrochloride tablet is more than 100-fold higher than the daily dose following Relestat. In addition, the metabolism of epinastine in humans is minimal (<10%). Therefore, no dosage adjustment is considered to be necessary.
Patients with renal impairment Relestat has not been studied in patients with renal impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicate that there are no particular safety issues for patients with renal impairment.
As such, no dosage adjustment is considered to be necessary. Method of administration Relestat is for topical ophthalmic use only. To avoid contamination of the eye or eye drops, do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic medicinal product is being used, the different medicinal products should be administered at least 10 minutes apart.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[2]

Summary of the safety profile In clinical studies, the overall incidence of adverse reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.
Tabulated list of adverse reactions Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreased seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: 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); very rare (<1/10 000); not known (cannot be estimated from the available data).
The following adverse reactions have been reported with epinastine:
System Organ Class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reaction including symptoms or signs of eye allergy and extra-ocular allergic reactions, including angioedema, skin rash and redness Nervous system disorders Uncommon Headache Common Burning sensation, eye irritation Uncommon Conjunctival/ocular hyperaemia, eye discharge, eye dryness, eye pruritus, visual disturbance Eye disorders Not known Increased lacrimation, eye pain, eye swelling, eyelid oedema Respiratory, thoracic and mediastinal disorders Uncommon Asthma, nasal irritation, rhinitis Gastrointestinal disorders Uncommon Dysgeusia Paediatric population Frequency, type and severity of adverse reaction in adolescents ≥ 12 years of age are expected to be the same as in adults.
There is limited experience in children aged 3-12 years regarding frequency, type and severity of adverse reactions. 4). 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 May 15, 2026[2]

Relestat is for topical ophthalmic use only and not for injection or oral use. Excipients with known effect Benzalkonium chloride Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be instructed to remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use. Phosphates Relestat also contains phosphates. 8)

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

Overview

Regulatory status by market

USUnited States· FDA

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations