Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Agomelatine
Drug ID BADD_D00050
Description Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was developed in Europe by Servier Laboratories Ltd. and submitted to the European Medicines Agency (EMA) in 2005. The Committee for Medical Products for Human Use (CHMP) recommended refusal of marketing authorization on 27 July 2006. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis. The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.
Indications and Usage Agomelatine is indicated for the treatment of major depressive episodes in adults.
Marketing Status Not Available
ATC Code N06AX22
DrugBank ID DB06594
KEGG ID D02578
MeSH ID C084711
PubChem ID 82148
TTD Drug ID D0Y8UB
NDC Product Code 50370-0041; 50370-0053
Synonyms agomelatine | N-(2-(7-methoxy-1-naphthyl)ethyl)acetamide | AGO 178 | AGO178 | AGO-178 | Thymanax | Valdoxan | S20098 | S 20098 | S-20098
Chemical Information
Molecular Formula C15H17NO2
CAS Registry Number 138112-76-2
SMILES CC(=O)NCCC1=CC=CC2=C1C=C(C=C2)OC
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
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
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Constipation07.02.02.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Ear disorder04.03.01.001--Not Available
Eczema23.03.04.006--
Eye disorder06.08.03.001--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypomania19.16.02.001--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
The 1th Page    1 2    Next   Last    Total 2 Pages