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)
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Galactorrhoea05.03.04.002; 21.05.02.002--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypomania19.16.02.001--Not Available
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Ileus paralytic07.02.05.001--Not Available
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intraocular pressure increased13.07.04.002--Not Available
Jaundice cholestatic09.01.01.005--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Mental disability26.01.01.001--Not Available
Mental impairment19.21.02.003; 17.03.03.002--Not Available
Movement disorder17.01.02.010--Not Available
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nightmare19.02.03.003--Not Available
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