Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ketotifen
Drug ID BADD_D01234
Description Ketotifen is a benzocycloheptathiophene derivative[A231204] with potent antihistaminic and mast cell stabilizing properties. It has a similar structure to some other first-generation antihistamines such as [cyproheptadine] and [azatadine].[A231204] Ketotifen was first developed in Switzerland in 1970 by Sandoz Pharmaceuticals and was initially marketed for the treatment of anaphylaxis.[A231204] In the US, it is now used in an over-the-counter ophthalmic formulation for the treatment of itchy eyes associated with allergies,[L32278] and in Canada a prescription-only oral formulation is available and indicated as an add-on therapy for children with atopic asthma.[L32283] In addition, oral ketotifen is used in Mexico and across Europe for the treatment of various allergic symptoms and disorders,[A231204] including urticaria, mastocytosis, and food allergy.
Indications and Usage Administered orally, ketotifen is indicated as an add-on medication in the chronic treatment of mild atopic asthma in children.[L32283] It is also available as an over-the-counter ophthalmic solution which is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.[L32278]
Marketing Status approved
ATC Code R06AX17; S01GX08
DrugBank ID DB00920
KEGG ID D08105
MeSH ID D007665
PubChem ID 3827
TTD Drug ID D0YG7M
NDC Product Code Not Available
UNII X49220T18G
Synonyms Ketotifen | Ketotiphene | Ketotiphen | 4,9-Dihydro-4-(1-methyl-4-piperidylidene)-10H-benzo(4,5)-cyclohepta(1,2-b)thiophen-10-one | Ketotifene | Zaditen | Ketotifen Fumarate | Fumarate, Ketotifen
Chemical Information
Molecular Formula C19H19NOS
CAS Registry Number 34580-13-7
SMILES CN1CCC(=C2C3=C(C(=O)CC4=CC=CC=C42)SC=C3)CC1
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)
Abdominal pain07.01.05.002--
Bladder pain20.02.02.001--Not Available
Body temperature increased13.15.01.001--Not Available
Cystitis20.03.02.002; 11.01.14.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Epistaxis22.04.03.001; 24.07.01.005--
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye irritation06.04.05.0030.002514%Not Available
Eye pain06.08.03.0020.000709%
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Gastrointestinal pain07.01.05.005--
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hypersensitivity10.01.03.0030.001096%
Hypertension24.08.02.001--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Instillation site pain08.02.01.008; 12.07.01.0080.001096%Not Available
Irritability19.04.02.013; 08.01.03.011--
Loss of consciousness17.02.04.004--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Ocular hyperaemia06.04.05.0040.001257%Not Available
Pain08.01.08.004--
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