Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Doxepin
Drug ID BADD_D00720
Description Doxepin is a psychotropic agent with antidepressant and anxiolytic properties.[T559] It is a tertiary amine that can be presented as (E) and (Z) stereoisomers with the (Z) stereoisomer corresponding to [cidoxepin]. Doxepin commonly produces a 5:1 (E):(Z) racemic mixture.[T83] In a strict sense, doxepin is not a tricyclic antidepressant but it is commonly associated with the class since it shares a lot of properties with members of the drug family including [amitriptyline], [clomipramine], [desipramine], [imipramine], [nortriptyline], [protriptyline] and [trimipramine].[L5977] Doxepin was developed by Pfizer and FDA approved in 1969 as an antidepressant.[L5971] However, in 2010 it was approved for the treatment of insomnia. The latter indication was presented by Pernix Therapeutics.[L5974]
Indications and Usage - Indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus [L1344].
Marketing Status Prescription; Discontinued
ATC Code D04AX01; N06AA12
DrugBank ID DB01142
KEGG ID D07875
MeSH ID D004316
PubChem ID 3158
TTD Drug ID D06FES
NDC Product Code 0228-3315; 72819-161; 0228-3316; 72819-162
Synonyms Doxepin | Deptran | Desidox | Doneurin | Doxepia | Doxepin beta | Doxepin Hydrochloride | Hydrochloride, Doxepin | Doxepin Hydrochloride, Cis-Trans Isomer Mixture (approximately 1:5) | Doxepin-RPh | Doxepin RPh | Espadox | Mareen | Novo-Doxepin | Novo Doxepin | Prudoxin | Quitaxon | Sinequan | Sinquan | Zonalon | Xepin | Aponal | Apo-Doxepin | Apo Doxepin | ApoDoxepin
Chemical Information
Molecular Formula C19H21NO
CAS Registry Number 1668-19-5
SMILES CN(C)CCC=C1C2=CC=CC=C2COC3=CC=CC=C31
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Affective disorder19.04.04.0010.001553%Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Aggression19.05.01.0010.001036%Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.001036%Not Available
Anaemia01.03.02.001--
Anticholinergic syndrome17.05.01.0010.001036%Not Available
Anxiety19.06.02.0020.001553%
Aphthous ulcer07.05.06.002--Not Available
Apnoea22.02.01.001--
Application site reaction08.02.01.006; 12.07.01.006--Not Available
Arrhythmia02.03.02.0010.001036%Not Available
Arthralgia15.01.02.001--
Aspiration22.02.07.007--
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Ataxia08.01.02.004; 17.02.02.001--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.0030.001036%
Back injury12.01.09.002--Not Available
Back pain15.03.04.005--
Bezoar07.11.01.0080.000270%Not Available
Blepharospasm06.05.01.001; 17.17.02.001--Not Available
Blood glucose increased13.02.02.002--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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