Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Olopatadine hydrochloride
Drug ID BADD_D01606
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 S01GX09; R01AC08
DrugBank ID DB00768
KEGG ID D01192
MeSH ID D000069605
PubChem ID 5282402
TTD Drug ID D05GPO
NDC Product Code 62332-709; 69097-600; 50090-3566; 79903-001; 65089-0041; 71684-0816; 17478-308; 58602-010; 62332-502; 0065-4274; 12079-2002; 55545-0464; 50090-6341; 58602-007; 58602-013; 60505-6221; 60505-6222; 0363-8022; 67172-504; 72036-009; 79481-1001; 52133-0036; 17478-105; 45802-104; 0065-8150; 79903-000; 0078-0834; 30142-064; 46122-672; 50090-3489; 58602-012; 61314-320; 62332-501; 0065-0816; 14445-009; 62147-0117; 17478-305; 50090-5613; 53002-0510; 0363-0200; 62332-710; 63629-8434; 68001-530; 76420-089; 14501-0050; 46122-671; 51407-663; 60505-0845; 65162-890; 72476-851; 72476-852; 79481-1000; 80539-001; 48087-0100; 62147-0118; 66039-935; 17478-312; 30142-026; 58602-006; 58602-009; 70069-007; 71205-345; 72036-008; 54752-0006; 51407-499
UNII 2XG66W44KF
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 C21H24ClNO3
CAS Registry Number 140462-76-6
SMILES CN(C)CCC=C1C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O.Cl
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)
Asthenia08.01.01.001--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Cough22.02.03.001--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Epistaxis24.07.01.005; 22.04.03.001--
Eyelid oedema10.01.05.001; 06.04.04.004; 23.04.01.003--Not Available
Fatigue08.01.01.002--
Headache17.14.01.001--
Hyperaemia24.03.02.002--Not Available
Hypersensitivity10.01.03.003--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Keratitis06.04.02.002--
Laryngeal pain22.12.03.010--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Pharyngitis11.01.13.003; 07.05.07.004; 22.07.03.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Sinusitis22.07.03.007; 11.01.13.005--
Somnolence17.02.04.006; 19.02.05.003--
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
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