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)
Injection site scar23.03.11.016; 12.07.03.050; 08.02.03.0500.003971%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system16.22.02.004; 17.02.10.0130.002169%Not Available
Infusion site rash23.03.13.018; 12.07.05.017; 08.02.05.0170.001135%Not Available
Drug resistance08.06.01.0050.000667%Not Available
Induration08.01.03.0200.000734%Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Breast disorder21.05.04.004--Not Available
Connective tissue disorder15.06.01.006; 10.04.04.026--Not Available
Embolism24.01.01.0090.001168%
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.001301%Not Available
Malnutrition14.03.02.004--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Disease progression08.01.03.0380.015049%
Neoplasm recurrence16.16.02.0040.000334%Not Available
Hepatic lesion09.01.08.0050.000501%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Metastasis16.22.01.0010.002336%Not Available
Anaphylactoid shock10.01.07.004; 24.06.02.0050.000334%Not Available
Hypophagia14.03.01.006; 19.09.01.004; 07.01.06.0100.000501%Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.004238%
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Bone marrow failure01.03.03.0050.000501%
Injection site injury12.07.03.046; 08.02.03.0460.001869%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000501%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.001869%Not Available
Injury associated with device12.01.08.035; 08.07.01.0120.001702%Not Available
Upper-airway cough syndrome22.12.03.0360.002269%
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