pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-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 openFDA

Directions 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 openFDA

For 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

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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.
  1. 1Treatment Failure2,51325%
  2. 2Drug Ineffective9329.1%
  3. 3Device Delivery System Issue7026.9%
  4. 4Product Use In Unapproved Indication6896.7%
  5. 5Drug Dose Omission By Device5185.1%
  6. 6Product Use Issue4854.8%
  7. 7Eye Irritation3353.3%
  8. 8Headache3293.2%
  9. 9Nausea2842.8%
  10. 10Fatigue2702.6%
  11. 11Vision Blurred2682.6%
  12. 12Dyspnoea2622.6%
  13. 13Rash2562.5%
  14. 14Diarrhoea2362.3%
  15. 15Hypersensitivity2312.3%

Literature

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Recent PubMed references pinned to Olopatadine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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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.

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.

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