Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clemastine fumarate
Drug ID BADD_D00481
Description An ethanolamine-derivative, first generation histamine H1 antagonist used in hay fever, rhinitis, allergic skin conditions, and pruritus. It causes drowsiness.
Indications and Usage For the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and acrimation. Also for the management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Used as self-medication for temporary relief of symptoms associated with the common cold.
Marketing Status approved; investigational
ATC Code D04AA14; R06AA04
DrugBank ID DB00283
KEGG ID D00666
MeSH ID D002974
PubChem ID 5281069
TTD Drug ID D0C5XC
NDC Product Code 62135-713; 73377-061; 73308-358; 0093-0308; 55152-001
UNII 19259EGQ3D
Synonyms Clemastine | Mecloprodin | 2-(2-(1-(4-Chlorophenyl)-1-phenylethoxy)ethyl)-1-methylpyrrolidine | Meclastine | Tavist | Tavegyl | Clemastine Fumarate | HS-592 | HS 592 | HS592
Chemical Information
Molecular Formula C25H30ClNO5
CAS Registry Number 14976-57-9
SMILES CC(C1=CC=CC=C1)(C2=CC=C(C=C2)Cl)OCCC3CCCN3C.C(=CC(=O)O)C(=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)
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Asthenia08.01.01.001--Not Available
Chest discomfort02.02.02.009; 22.12.02.002; 08.01.08.019--Not Available
Chills15.05.03.016; 08.01.09.001--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Conversion disorder19.24.01.001--Not Available
Coordination abnormal17.02.02.004--Not Available
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.002--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Dry mouth07.06.01.002--
Dry throat22.12.03.005; 07.06.01.005--Not Available
Dyspepsia07.01.02.001--
Dysuria20.02.02.002--
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypotension24.06.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Labyrinthitis11.01.05.002; 04.04.03.001--Not Available
Menstruation irregular21.01.01.005; 05.05.01.008--
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