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 to treat major depressive episodes in adults.
Marketing Status approved; investigational
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
UNII 137R1N49AD
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
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)
Irritability19.04.02.013; 08.01.03.011--
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Mania19.16.02.002--
Migraine24.03.05.003; 17.14.02.001--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nightmare19.02.03.003--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Pruritus23.03.12.001--
Rash erythematous23.03.13.029--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.003--
Tinnitus17.04.07.004; 04.04.01.002--
Tremor17.01.06.002--
Urticaria10.01.06.001; 23.04.02.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Mental disorder19.07.01.002--Not Available
Inner ear disorder04.04.02.002--Not Available
Hepatobiliary disease09.01.08.003--Not Available
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