Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dothiepin hydrochloride
Drug ID BADD_D00714
Description Dosulepin (INN, BAN) formerly known as dothiepin (USAN), is a tricyclic antidepressant with anxiolytic properties that is used in several European and South Asian countries, as well as Australia, South Africa, and New Zealand. It is not FDA-approved due to low therpeutic index and significant toxicity in overdose. Dosulepin inhibits the reuptake of biogenic amines, increasing available neurotransmitter levels at the synaptic cleft. The use of dosulepsin is only recommended in patients who are intolerant or unresponsive to alternative antidepressant therapies. Dosulepsin is a thio derivative of [DB00321] with a similar efficacy to that of [DB00321], and also exhibits anticholinergic, antihistamine and central sedative properties [L882]. Its hydrochloride form is a common active ingredient in different drug formulations.
Indications and Usage Indicated in the treatment of symptoms of depressive illness, especially where an anti-anxiety effect is required.
Marketing Status approved
ATC Code N06AA16
DrugBank ID DB09167
KEGG ID D01546
MeSH ID D004308
PubChem ID 6420022
TTD Drug ID D0Q2MN
NDC Product Code 71554-005
UNII 3H0042311V
Synonyms Dothiepin | Dosulepin | Prothiaden | Dothiepin Hydrochloride | Hydrochloride, Dothiepin
Chemical Information
Molecular Formula C19H22ClNS
CAS Registry Number 25627-39-8
SMILES CN(C)CCC=C1C2=CC=CC=C2CSC3=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)
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.002--Not Available
Blister12.01.06.002; 23.03.01.001--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Conduction disorder02.03.01.008--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Delusion19.10.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Endocrine disorder05.09.01.001--Not Available
Eosinophilia01.02.04.001--
Extrapyramidal disorder17.01.02.007--
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