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 Not Available
Marketing Status Not Available
ATC Code N06AA16
DrugBank ID DB09167
KEGG ID D01546
MeSH ID D004308
PubChem ID 6420022
TTD Drug ID D0Q2MN
NDC Product Code 71554-005
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
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)
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Palpitations02.01.02.003--
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005--
Pollakiuria20.02.02.007--
Rash23.03.13.001--Not Available
Seizure17.12.03.001--
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.005--
Tachycardia02.03.02.007--Not Available
Testicular swelling21.13.01.003--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tongue discolouration07.14.02.006--Not Available
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Malnutrition14.03.02.004--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.001--
Bone marrow failure01.03.03.005--
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