Olopatadine
GET
/api/v1/drug/olopatadineMechanism of action
Sourced from openFDAMechanism-of-action class: Histamine H1 Receptor Antagonists.
Histamine H1 Receptor
Indications
Sourced from openFDA- Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Dosage & administration
Sourced from openFDADirections adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, no more than once per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor
Warnings & precautions
Sourced from openFDAFor external use only
Approval history
Sourced from openFDA- Dec 18, 1996NDANDA020688Alcon Labs Inc
- Dec 22, 2004NDANDA021545Alcon Labs Inc
- Oct 8, 2014ANDAANDA091572Apotex Inc
- Jan 30, 2015NDANDA206276Alcon Labs Inc
- Dec 7, 2015ANDAANDA203152Usv
- Dec 7, 2015ANDAANDA206306Somerset Theraps Llc
- Dec 7, 2015ANDAANDA078350Apotex
- Jan 13, 2022NDANDA211746Glenmark Speclt
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
10,209 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Treatment Failure2,51325%
- 2Drug Ineffective9329.1%
- 3Device Delivery System Issue7026.9%
- 4Product Use In Unapproved Indication6896.7%
- 5Drug Dose Omission By Device5185.1%
- 6Product Use Issue4854.8%
- 7Eye Irritation3353.3%
- 8Headache3293.2%
- 9Nausea2842.8%
- 10Fatigue2702.6%
- 11Vision Blurred2682.6%
- 12Dyspnoea2622.6%
- 13Rash2562.5%
- 14Diarrhoea2362.3%
- 15Hypersensitivity2312.3%
Literature
Recent PubMed references pinned to Olopatadine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Cohort Study of Pregnancy Outcomes After Exposure to Fexofenadine or Olopatadine in the First Trimester.Congenital anomalies · 2026 · Yamazaki K, Goto M, Koinuma S, et al.PMID 41999235DOI 10.1002/cga.70056
- Bioequivalence Study of Two Olopatadine Hydrochloride Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions.Clinical pharmacology in drug development · 2026 · Lei Y, Pei F, Wu Q, et al.PMID 41253596DOI 10.1002/cpdd.1629
- Comparing the effectiveness of four antihistamines with olopatadine in healthy Thoroughbred horses.The Journal of veterinary medical science · 2025 · Ikeda Y, Kuroda T, Mita H, et al.PMID 39805609DOI 10.1292/jvms.24-0412
- Implantation of impressive chromatographic and built-in UV spectrophotometry approaches for sustainable Estimation of olopatadine and mometasone in pharmaceuticals; eco-scale and BAGI applications.Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2025 · El-Masry AA, Elsabour SA, Emad F Abbas A, et al.PMID 39547146DOI 10.1016/j.saa.2024.125409
- Development of a Temperature and pH Dual-Sensitive In-Situ Gel for Treating Allergic Conjunctivitis.AAPS PharmSciTech · 2024 · Zhu Y, Liu Y, Wang Y, et al.PMID 39322789DOI 10.1208/s12249-024-02931-6
- Green and sensitive detection of olopatadine in aqueous humor using a signal-on fluorimetric approach: GREEnness assessment.Luminescence : the journal of biological and chemical luminescence · 2024 · Mostafa IM, Omar MA, Noureldeen DAM, et al.PMID 39011865DOI 10.1002/bio.4814
- Intranasal combo: fixed-dose combination of mometasone furoate and olopatadine hydrochloride in therapeutic strategies for rhinosinusitis.Otolaryngologia polska = The Polish otolaryngology · 2023 · Samoliński B, Wojas O, Lipiec A, et al.PMID 38706259DOI 10.5604/01.3001.0054.0941
- Efficacy of the topical antihistamine olopatadine in dogs with experimentally induced allergic conjunctivitis.Veterinary ophthalmology · 2024 · Mamo ET, Newbold GM, Moorehead SC, et al.PMID 38066706DOI 10.1111/vop.13168
Clinical trials
The 10 most recently updated of 65 ClinicalTrials.gov registrations naming Olopatadine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)Not yet recruiting · Observational · 132 enrolled · The Fourth Affiliated Hospital of Zhejiang University School of MedicineNCT07557888updated 2026-05-07
- Azelastine Allergen Chamber - Onset of Action StudyCompleted · Phase 2 · Interventional · 84 enrolled · MEDA Pharma GmbH & Co. KGNCT06126952updated 2024-03-20
- Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic ConjunctivitisCompleted · Phase 2 · Interventional · 122 enrolled · Senju USA, Inc.NCT00836485updated 2023-08-04
- Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis TreatmentCompleted · Phase 4 · Interventional · 97 enrolled · Laboratorios PoenNCT04776096updated 2022-12-15
- Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic ConjunctivitisUnknown · Phase 4 · Interventional · 42 enrolled · Michael Marchand, MDNCT03186755updated 2022-10-26
- Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic ConjunctivitisCompleted · Phase 2 · Interventional · 120 enrolled · ORA, Inc.NCT03320434updated 2022-10-17
- A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic ConjunctivitisCompleted · Phase 4 · Interventional · 61 enrolled · Andover Research Eye InstituteNCT05314621updated 2022-09-02
- A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic ConjunctivitisCompleted · Phase 4 · Interventional · 58 enrolled · Andover Research Eye InstituteNCT05265910updated 2022-05-03
- Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis TrialCompleted · Phase 1 · Interventional · 48 enrolled · Second Affiliated Hospital of Nanchang UniversityNCT05353101updated 2022-04-29
- DEXTENZA Therapy for Treatment of Allergic ConjunctivitisCompleted · Phase 4 · Interventional · 31 enrolled · Clinical Research Center of FloridaNCT04708821updated 2022-04-13
Frequently asked questions
- How does Olopatadine work?
- Mechanism-of-action class: Histamine H1 Receptor Antagonists.
- What is Olopatadine used for?
- According to FDA labeling, Olopatadine carries indications including: Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Olopatadine?
- Olopatadine is classified as Antiallergic agents, excl. corticosteroids, Other antiallergics, Histamine-1 Receptor Antagonist, Histamine-1 Receptor Inhibitor, Mast Cell Stabilizer, Histamine H1 Receptor Antagonists, Decreased Histamine Activity, Decreased Histamine Release.
- What are the brand names for Olopatadine?
- Olopatadine is marketed under brand names including PATANASE, Pataday, Ryaltris.
Note. Data for
olopatadine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.