Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tibolone
Drug ID BADD_D02213
Description Tibolone is a synthetic steroid hormone drug, which is mainly non-selective in its binding profile, acting as an agonist primarily at estrogen receptors (ER), with a preference for ER alpha [L1874]. Tibolone (Livial, Org OD 14), produced by Organon (West Orange, NJ), is a synthetic steroid that possesses estrogenic, androgenic and progestogenic properties. It has been used in Europe for almost 2 decades, primarily for the prevention of postmenopausal osteoporosis and the treatment of post-menopausal symptoms [L1720]. Tibolone is approved in 90 countries to manage menopausal symptoms and in 45 countries to prevent the development of osteoporosis [L1876]. In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tibolone had not been approved [L1722]. Interestingly, the use of tibolone in the treatment cardiovascular disease has been studied with inconclusive results [A32164]. Tibolone has been to have anti-resorptive effects on bone [L1874].
Indications and Usage For the relief of post-menopausal symptoms and for the prevention of osteoporosis [L1724].
Marketing Status Not Available
ATC Code G03CX01
DrugBank ID DB09070
KEGG ID D01639
MeSH ID C027385
PubChem ID 444008
TTD Drug ID D0W3OS
NDC Product Code 51508-010; 24002-0033
Synonyms tibolone | tibilone | Org OD 14 | Org OD14 | Livial | Liviella | Boltin
Chemical Information
Molecular Formula C21H28O2
CAS Registry Number 5630-53-5
SMILES CC1CC2=C(CCC(=O)C2)C3C1C4CCC(C4(CC3)C)(C#C)O
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)
Pruritus23.03.12.001--
Pruritus genital23.03.12.008; 21.10.01.002--Not Available
Pulmonary embolism22.06.02.001; 24.01.06.001--Not Available
Rash23.03.13.001--Not Available
Skin disorder23.03.03.007--Not Available
Smear cervix abnormal13.20.02.001--Not Available
Vaginal discharge21.08.02.002--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vascular purpura01.01.04.007; 24.07.06.011; 23.06.01.008--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Vulvovaginitis21.14.02.005; 11.01.10.003--Not Available
Weight increased13.15.01.006--
Breast discomfort21.05.05.007--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Genital discharge21.10.01.006--Not Available
Breast disorder21.05.04.004--Not Available
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Gastrointestinal tract irritation07.08.03.008--Not Available
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