Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Carbinoxamine maleate
Drug ID BADD_D00362
Description Carbinoxamine is a first generation antihistamine that competes with free histamine for binding at HA-receptor sites. This antagonizes the effects of histamine on HA-receptors, leading to a reduction of the negative symptoms brought on by histamine HA-receptor binding. The product label for carbinoxamine as an over the counter cough and cold medicine is being modified to state "do not use" in children under 4 years of age in order to prevent and reduce misuse, as many unapproved carbinoxamine-containing preparations contained inappropriate labeling, which promoted unapproved uses (including management of congestion, cough, the common cold, and the use in children under 2 years of age), which can potentially cause serious health risks.
Indications and Usage For symptomatic relief of seasonal and perennial allergic rhinitis and vasomotor rhinitis, as well as allergic conjunctivitis caused by foods and inhaled allergens. Also for the relief of allergic reactions to blood or plasma, and the symptomatic management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Marketing Status approved
ATC Code R06AA08
DrugBank ID DB00748
KEGG ID D01336
MeSH ID C004649
PubChem ID 5282409
TTD Drug ID D00FGV
NDC Product Code 66022-0121; 67763-110; 15370-130; 64950-243; 69067-240; 44523-825; 23594-101; 51991-333; 12294-0056; 51991-334; 50370-0006
UNII 02O55696WH
Synonyms carbinoxamine | Histex PD | Histex I-E | carbinoxamine maleate | Histex CT
Chemical Information
Molecular Formula C20H23ClN2O5
CAS Registry Number 3505-38-2
SMILES CN(C)CCOC(C1=CC=C(C=C1)Cl)C2=CC=CC=N2.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
Chest discomfort08.01.08.019; 02.02.02.009; 22.12.02.002--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
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
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--
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--
Nasal congestion22.04.04.001--
Nasal dryness22.04.03.002--Not Available
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