Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dienogest
Drug ID BADD_D02619
Description Dienogest is an orally-active semisynthetic progestogen which also possesses the properties of 17α-hydroxyprogesterone. It is a derivative of 19-nortestosterone and has antiandrogenic properties. It is primarily used as a contraceptive in combination with ethinylestradiol, or in other combination form pills approved in United States and Europe however it is not available in the US by itself. In Europe, Australia, Malaysia, Singapore and Japan, dienogest single therapy is an approved treatment for endometriosis to alleviate painful symptoms of endometriosis and reduce endometriotic lesions [A20330]. Dienogest is commonly marketed as Visanne, Natazia and Qlaira.
Indications and Usage Indicated for use as the treatment of endometriosis alone and as a contraceptive in combination with ethinylestradiol.
Marketing Status approved
ATC Code G03DB08
DrugBank ID DB09123
KEGG ID D03799
MeSH ID C023635
PubChem ID 68861
TTD Drug ID D04CBI
NDC Product Code 77382-0130; 24002-0034; 63190-0270
UNII 46M3EV8HHE
Synonyms dienogest | 17 alpha-cyanomethyl-17 beta-hydroxy-13 beta-methylgona-4,9-dien-3-one | 17 alpha-cyanomethyl-17 beta-hydroxyestra-4,9(10)-diene-3-one | 19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)- | STS 557 | STS-557
Chemical Information
Molecular Formula C20H25NO2
CAS Registry Number 65928-58-7
SMILES CC12CCC3=C4CCC(=O)C=C4CCC3C1CCC2(CC#N)O
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--
Abdominal pain upper07.01.05.003--
Amenorrhoea05.05.01.002; 21.01.02.001--
Anxiety19.06.02.002--
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Breast cancer16.10.01.001; 21.05.01.003---
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.002---
Depression19.15.01.001--
Dermatitis allergic10.01.03.014; 23.03.04.003---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry eye06.08.02.001--
Endometriosis21.07.01.004---
Feeling abnormal08.01.09.014---
Headache17.14.01.001--
Increased appetite08.01.09.027; 14.03.01.003---
Insomnia17.15.03.002; 19.02.01.002--
Menstruation irregular05.05.01.008; 21.01.01.005--
Migraine17.14.02.001; 24.03.05.003---
Mood altered19.04.02.007---
Mood swings19.04.03.001---
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.005--
Nausea07.01.07.001--
Ovarian cyst16.04.03.001; 21.11.01.002---
Pain08.01.08.004--
Paraesthesia17.02.06.005; 23.03.03.094--
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