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)
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000834%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.008075%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.002002%Not Available
Metastases to skin16.22.02.023; 23.07.04.0260.001235%Not Available
Terminal state08.01.03.0790.000501%Not Available
Metastases to bone marrow16.22.02.013; 01.05.01.0220.000334%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.001001%Not Available
Allergic cough22.02.03.011; 10.01.03.0400.000334%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.005506%Not Available
Embolia cutis medicamentosa24.01.01.030; 12.07.03.052; 08.02.03.0520.000501%Not Available
Exposed bone in jaw15.02.04.0340.000501%Not Available
Tongue discomfort07.14.02.0190.001135%Not Available
Administration site pain12.07.04.029; 08.02.04.0290.001301%Not Available
Administration site urticaria23.04.02.013; 12.07.04.034; 10.01.06.013; 08.02.04.0340.000734%Not Available
Hormone receptor positive breast cancer21.05.01.028; 16.10.01.018--Not Available
Hormone receptor positive HER2 negative breast cancer16.10.01.017; 21.05.01.0270.000334%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000334%Not Available
Injection site hypoaesthesia12.07.03.060; 08.02.03.060; 17.02.06.0510.001068%Not Available
Injection site nerve damage12.07.03.066; 08.02.03.0660.001635%Not Available
Left atrial enlargement02.04.02.0420.000334%Not Available
Limb mass15.03.05.0190.000734%Not Available
Myelosuppression01.03.03.0150.001668%Not Available
Reaction to excipient10.01.01.0420.000334%Not Available
Red cell fragmentation syndrome08.07.01.043; 01.06.02.0040.000501%Not Available
Therapy partial responder08.06.01.0640.000501%Not Available
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