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)
Respiratory failure22.02.06.002; 14.01.04.0030.001036%
Restlessness19.11.02.002; 17.02.05.0210.001036%
Rhabdomyolysis15.05.05.0020.001553%
Rhinorrhoea22.02.05.010--
Rosacea23.02.08.001--Not Available
Sedation17.02.04.0050.001036%Not Available
Seizure17.12.03.0010.003625%
Sensory loss17.02.07.007--Not Available
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Skin irritation23.03.04.009--Not Available
Sleep paralysis19.02.02.004; 17.15.02.005--Not Available
Somnambulism19.02.03.006; 17.15.02.0040.001036%Not Available
Somnolence19.02.05.003; 17.02.04.0060.003625%
Stomatitis07.05.06.005--
Suicidal ideation19.12.01.0030.000675%
Suicide attempt19.12.01.0040.001553%
Syncope24.06.02.012; 02.01.02.008; 17.02.04.0080.002589%
Tachycardia02.03.02.0070.002589%Not Available
Tardive dyskinesia17.01.02.012--Not Available
Tension19.06.02.005--Not Available
Testicular swelling21.13.01.003--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.001--Not Available
Tinnitus04.04.01.002; 17.04.07.0040.001036%
Tremor17.01.06.002--
Tympanic membrane perforation12.01.14.001; 04.05.04.001--Not Available
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