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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pharyngeal disorder22.04.05.007--Not Available
Acute kidney injury20.01.03.0160.003625%
Multiple organ dysfunction syndrome08.01.03.0570.000270%
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.001036%Not Available
Small for dates baby18.04.02.0020.001036%Not Available
Abortion late18.01.01.0040.001036%Not Available
Poor sucking reflex18.04.04.011; 17.02.01.0080.001036%Not Available
Heart injury12.01.11.003; 02.01.01.0100.001036%Not Available
Foetal monitoring abnormal13.21.01.0070.001553%Not Available
Selective eating disorder14.03.02.024; 19.09.01.0120.001036%Not Available
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