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Molecule

Olopatadine

Also known as olopatadine hydrochloride
Available on requestOphthalmology
Presentations
3
Brands
0
Manufacturers
0
Available from stock
0

Olopatadine is a histamine-1 receptor inhibitor indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. MedsAcross supplies Olopatadine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer, Histamine H1 Receptor Antagonists, Decreased Histamine Release
ATC classification
R01AC08 Olopatadine · Topical decongestant, subgroup R01ACS01GX09 Olopatadine · Eye medicines, subgroup S01G, subgroup S01GX
US FDA first approval
18 December 1996
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Nasal, Ophthalmic
Dosage forms
Nasal spray, Eye drops
Identifiers
UNII D27V6190PMRxCUI 135391CAS 113806-05-6DrugBank DB00768Q3267092

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. Olopatadine hydrochloride nasal spray is an H 1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.

Source: US FDA prescribing information

How it works

Olopatadine is a histamine H 1 receptor antagonist. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

Source: US FDA prescribing information

Dosing overview

For nasal use only. Recommended dosages: Adults and Adolescents ≥12 Years: Two sprays per nostril (665 mcg per spray) twice daily. Pediatric Patients 6 to 11 Years: One spray per nostril (665 mcg per spray) twice daily. Priming Information: Prime olopatadine hydrochloride nasal spray before initial use and when olopatadine hydrochloride nasal spray has not been used for more than 7 days.

Source: US FDA prescribing information

Warnings and precautions

Epistaxis, Nasal Ulceration, and Nasal Septal Perforation: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue if ulcerations or perforations occur. Avoid use in patients with nasal disease other than allergic rhinitis. Avoid engaging in hazardous occupations requiring complete mental alertness and coordination, such as driving or operating machinery when taking olopatadine hydrochloride nasal spray. Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride nasal spray.

Source: US FDA prescribing information

Side effects

The most clinically significant adverse reactions described in other sections of labeling include: Epistaxis, Nasal Ulceration, and Nasal Septal Perforation Somnolence and Impaired Mental Alertness The most common (> 1%) adverse reactions, included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection in patients 12 years of age and older and epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, and rash in patients 6 to 11 years of age.

Source: US FDA prescribing information

Interactions

Formal drug-drug interaction studies were not conducted for olopatadine hydrochloride nasal spray. Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected.

Source: US FDA prescribing information

Storage

Storage Store olopatadine hydrochloride nasal spray at room temperature between 4°C to 25°C (39°F to 77°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Olopatadine, sorted by availability.

MedicineManufacturerRegisterAvailability
Olopatadine 665 mcg nasal sprayNasalGeneric name—US FDAAvailable on request
Olopatadine 1 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Olopatadine 2 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 18 December 1996Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Olopatadine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Olopatadine available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Olopatadine and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Olopatadine approved by the US FDA?

Yes. The US FDA first approved Olopatadine on 18 December 1996, according to Drugs@FDA.

Is Olopatadine authorised in the European Union?

Yes. Olopatadine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Olopatadine need cold chain shipping?

No listed presentation of Olopatadine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Olopatadine in?

Olopatadine is classified under ATC code R01AC08 (Olopatadine).

References

  1. Olopatadine Hydrochloride prescribing information (Apotex). U.S. National Library of Medicine, DailyMed. Retrieved 15 September 2026
  2. Opatanol: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 January 2026

Request Olopatadine for export supply

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