Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Doxepin hydrochloride
Drug ID BADD_D00721
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 D00814
MeSH ID D004316
PubChem ID 6419921
TTD Drug ID D06FES
NDC Product Code 72789-072; 0904-7052; 0904-7055; 16714-135; 27241-169; 43353-331; 44183-103; 46708-640; 51672-4217; 55801-528; 59651-177; 60429-967; 63629-2180; 63629-5033; 69315-158; 69315-161; 70518-3020; 70518-3360; 70756-428; 71335-1770; 71921-164; 72205-088; 81469-417; 49452-2692; 10267-5061; 16714-133; 16714-136; 23155-795; 24658-796; 27241-170; 59651-176; 59746-704; 62135-562; 63629-3221; 0378-6410; 0378-8117; 69238-1173; 69315-163; 70518-2949; 70518-3327; 70518-3374; 70518-3490; 70518-3494; 71335-0072; 71921-165; 72205-053; 72205-090; 80425-0316; 81469-418; 24658-794; 0093-9609; 46708-638; 49884-218; 59746-703; 60429-966; 60429-968; 60429-970; 62135-560; 62135-564; 0378-5375; 69238-1166; 69315-159; 69315-162; 70518-2468; 71335-1665; 55801-527; 55801-529; 55801-530; 59651-173; 62135-561; 62332-639; 70518-3310; 70756-426; 71205-534; 71205-759; 71335-1450; 71921-166; 81469-419; 38779-0218; 62991-3029; 67651-0309; 24658-793; 42806-532; 55289-370; 55700-982; 59746-700; 64380-204; 0378-4811; 0527-4066; 70518-2371; 70518-3005; 71205-610; 71205-695; 71335-2092; 72205-089; 0904-7054; 51552-0982; 51927-0159; 72640-003; 23155-797; 42806-530; 42806-531; 42847-106; 46708-639; 46708-645; 49884-219; 51079-436; 51407-812; 51672-4219; 62135-563; 0378-3125; 68071-5260; 0527-4062; 0527-4063; 70518-3314; 70756-425; 70756-427; 71335-2188; 72189-161; 72205-091; 81469-415; 81469-416; 0904-7053; 17337-0513; 46438-0043; 10267-5062; 45865-103; 49884-221; 51672-4221; 59651-174; 59746-701; 62332-638; 0378-4250; 0378-8123; 0378-8130; 69238-1170; 0527-4065; 71335-1704; 71335-9732; 71921-163; 51927-2227; 42799-935; 45865-775; 54838-512; 59746-702; 60429-969; 62332-645; 63629-2181; 0378-1049; 64380-203; 70518-2984; 70518-3496; 70518-3594; 70756-424; 71335-2028; 71921-162; 10267-5059; 10267-5063; 67763-117; 16714-132; 16714-134; 24658-795; 27241-171; 44183-106; 49884-217; 49884-222; 51079-438; 51079-651; 51672-4220; 55700-917; 59651-175; 62332-637; 63629-2182; 0378-4810; 69238-1171; 69315-160; 70518-0386; 70518-3767; 71335-1941; 72205-092; 47621-063; 10267-5060; 71554-006; 23155-794; 42806-533; 42847-103; 45865-968; 46708-637; 50090-5286; 55700-928; 62332-640; 68071-2314; 68071-5179; 69238-1172; 0527-4064; 70518-3017; 72205-052; 72789-220; 67651-0308; 23155-796; 24658-797; 27241-167; 27241-168; 42291-247; 42806-529; 43353-329; 51079-437; 51407-811; 51672-4218
UNII 3U9A0FE9N5
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 C19H22ClNO
CAS Registry Number 1229-29-4
SMILES CN(C)CCC=C1C2=CC=CC=C2COC3=CC=CC=C31.Cl
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)
Agranulocytosis01.02.03.001---
Alopecia23.02.02.001--
Aphthous ulcer07.05.06.002---
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Ataxia08.01.02.004; 17.02.02.001--
Breast enlargement21.05.04.001---
Chills08.01.09.001; 15.05.03.016--
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Disorientation17.02.05.015; 19.13.01.002---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Eosinophilia01.02.04.001--
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Galactorrhoea05.03.04.002; 21.05.02.002---
Gynaecomastia05.05.02.003; 21.05.04.003--
Hallucination19.10.04.003--
Headache17.14.01.001--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hyperpyrexia08.05.02.002---
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023; 23.03.03.081---
Hypotension24.06.03.002--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
The 1th Page    1 2    Next   Last    Total 2 Pages