Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fulvestrant
Drug ID BADD_D00978
Description Fulvestrant is a drug treatment of hormone receptor (HR)-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor. While it is used as monotherapy for the treatment of breast cancers, it is also used in combination with [alpelisib] for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer
Indications and Usage For the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy, as monotherapy or in combination with other antineoplastic agents.
Marketing Status approved; investigational
ATC Code L02BA03
DrugBank ID DB00947
KEGG ID D01161
MeSH ID D000077267
PubChem ID 104741
TTD Drug ID D0JO7Y
NDC Product Code 46439-8769; 61662-0011; 0143-9022; 68001-522; 70860-211; 72603-105; 0781-9055; 64918-1402; 55150-394; 69910-0001; 70700-284; 71288-555; 70710-1688; 53183-9305; 59057-003; 16729-436; 0310-0720; 68001-484; 43598-262; 70121-1463; 0781-3492; 62332-650; 63323-715; 70771-1626; 0591-5019; 58175-0600; 66529-0014; 49803-011; 50923-0416; 16714-070; 25021-462; 0781-3079; 68462-317; 71731-6121; 63190-0300; 65129-2149
UNII 22X328QOC4
Synonyms Fulvestrant | 7-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl)estra-1,3,5(10)-triene-3,17-diol | Faslodex | ICI 182780 | ICI 182,780 | ICI-182780 | ICI182780 | ZM 182780 | ZM-182780 | ZM182780
Chemical Information
Molecular Formula C32H47F5O3S
CAS Registry Number 129453-61-8
SMILES CC12CCC3C(C1CCC2O)C(CC4=C3C=CC(=C4)O)CCCCCCCCCS(=O)CCCC(C(F)(F)F)(F)F
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)
Ulcer08.03.06.0010.001135%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine cancer21.07.02.003; 16.12.05.0010.000501%Not Available
Vaginal discharge21.08.02.002--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Wheezing22.03.01.0090.002770%
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000901%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000501%
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000334%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000901%Not Available
Malignant neoplasm progression16.16.01.0050.050218%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling08.02.03.017; 12.07.03.0180.006740%Not Available
Nodule08.03.05.0020.002836%Not Available
Injection site discomfort12.07.03.019; 08.02.03.0180.001301%Not Available
Skin burning sensation17.02.06.009; 23.03.03.0210.000334%Not Available
Cerebral disorder17.02.10.0170.000334%Not Available
Haemorrhage24.07.01.002--Not Available
Varices oesophageal07.15.05.001; 24.10.02.004; 09.01.06.0090.000334%Not Available
Urine odour abnormal20.02.01.0200.003404%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000334%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.002369%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.000334%Not Available
Injection site nodule23.07.04.009; 12.07.03.034; 08.02.03.0340.002369%Not Available
Vasodilation procedure25.03.01.001--Not Available
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