Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Olopatadine
Drug ID BADD_D01605
Description Olopatadine is a selective histamine H1 antagonist and mast cell stabilizer that works by attenuating inflammatory and allergic reactions. It is a structural analog of [doxepin], which has a minimal anti-allergic activity.[L6790] Olopatadine works by blocking the effects of histamine, which is a primary inflammatory mediator that causes inflammatory and allergic reactions. An ophthalmic solution of olopatadine was approved by the FDA and European Union for the treatment of seasonal and perennial allergic conjunctivitis in 1996 and 2002, respectively.[A1172] In comparison to other anti-allergenic ophthalmic medications, olopatadine displays a good comfort and tolerability profile since it does not cause perturbation of cell membranes.[A179809] Olopatadine is used for the symptomatic treatment of ocular itching associated with allergic conjunctivitis in ophthalmic formulations and seasonal allergic rhinitis in intranasal formulations. It is currently marketed under several brand names, including Pazeo, Patanase, and Opatanol.
Indications and Usage Olopatadine is indicated for the symptomatic treatment of ocular itching associated with allergic conjunctivitis as ophthalmic solution.[L6781] In nasal spray, olopatadine is indicated for the symptomatic relief of seasonal allergic rhinitis in patients 12 years of age and older.[L6784]
Marketing Status approved
ATC Code R01AC08; S01GX09
DrugBank ID DB00768
KEGG ID D08293
MeSH ID D000069605
PubChem ID 5281071
TTD Drug ID D05GPO
NDC Product Code Not Available
UNII D27V6190PM
Synonyms Olopatadine Hydrochloride | Hydrochloride, Olopatadine | KW-4943A | KW 4943A | KW4943A | Olopatadine | 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid | KW 4679 | 4679, KW | KW-4679 | Patanol
Chemical Information
Molecular Formula C21H23NO3
CAS Registry Number 113806-05-6
SMILES CN(C)CCC=C1C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Erythema of eyelid06.04.04.003; 23.03.06.006---
Eye discharge06.04.05.0010.000425%-
Eye disorder06.08.03.001---
Eye irritation06.04.05.0030.000849%-
Eye pain06.08.03.0020.000425%
Eye swelling06.08.03.0030.000275%-
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hyperaemia24.03.02.002---
Hypersensitivity10.01.03.0030.000637%
Hypoaesthesia17.02.06.023; 23.03.03.081---
Immune system disorder10.02.01.001---
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Insomnia17.15.03.002; 19.02.01.002--
Keratitis06.04.02.002--
Lacrimation increased06.08.02.004--
Laryngeal pain22.12.03.010--
Malaise08.01.01.003--
Muscle spasms15.05.03.004--
Mydriasis06.05.03.004; 17.02.11.003---
Nasal dryness22.04.03.002---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Ocular hyperaemia06.04.05.0040.000275%-
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