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 Oral doxepin is approved for the following indications: - Treatment of depression and/or anxiety.[A177163] - Treatment of depression and/or anxiety associated with different conditions, including alcoholism, organic disease and manic-depressive disorders.[T249] - Treatment of psychotic depressive disorders with associated anxiety.[T249] - Treatment of involutional depression.[T249] - Treatment of manic-depressive disorder.[T249] - Treatment of insomnia characterized by difficulties with sleep maintenance.[A177163] Topical doxepin is also approved for short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis, pruritus or lichen simplex chronicus.[T249] Off-label, doxepin is used topically for the management of neuropathic pain.[A177172] Depression is a common medical illness that causes feelings of sadness and or loss of interest in prior enjoyable activities. This condition can lead to emotional and physical disturbances that can decrease the ability of a person to function in a regular environment.[L5980] Anxiety is a normal reaction of the body towards a normal danger. When the anxious state is exacerbated or appears on situations without danger, it is defined as an anxiety disorder. This disorders can appear in different forms such as phobias, panic, obsessive-compulsive disorder and post-traumatic stress disorder.[L5983] Insomnia is a sleep disorder that directly affects the quality of life of the individual. It is characterized by the complication either to fall asleep or to stay asleep. This condition can be occasional or chronic.[L5986] Pruritus is defined as an unpleasant skin reaction that provokes the urge to scratch. It can be localized or generalized and it can appear in an acute or chronic manner.[L5989] Neuropathic pain occurs due to the damage or dysfunction of the peripheral or central nervous system rather than stimulation of the pain receptors.[L5992]
Marketing Status approved; investigational
ATC Code D04AX01; N06AA12
DrugBank ID DB01142
KEGG ID D07875
MeSH ID D004316
PubChem ID 3158
TTD Drug ID D06FES
NDC Product Code 72819-162; 72819-161; 70518-3495; 0228-3315; 0228-3316
UNII 5ASJ6HUZ7D
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
*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)
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002--Not Available
Apnoea22.02.01.001--
Application site reaction08.02.01.006; 12.07.01.006--Not Available
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Aspiration22.02.07.007--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia08.01.02.004; 17.02.02.001--
Atrioventricular block02.03.01.002--Not Available
Back injury12.01.09.002--Not Available
Back pain15.03.04.005--
Blepharospasm17.17.02.001; 06.05.01.001--Not Available
Blood glucose increased13.02.02.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Breast cyst21.05.01.006; 16.14.01.004--Not Available
Breast enlargement21.05.04.001--Not Available
The 1th Page    1 2 3 4 5    Next   Last    Total 9 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene