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 Indicated as an add-on or prophylactic oral medication in the chronic treatment of mild atopic asthmatic children. Also used as self-medication for the temporary relief of itching of the eye due to allergic conjunctivitis (ophthalmic).
Marketing Status OTC; Discontinued
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
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.03.020--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Conjunctival hyperaemia06.04.01.004--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Eyelid disorder06.08.03.010; 23.03.03.028--Not Available
Cystitis noninfective20.03.02.001--
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