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)
Metastases to lung16.22.02.002; 22.08.01.0050.001502%Not Available
Metastases to spine16.22.02.007; 15.09.03.0070.000501%Not Available
Mucosal inflammation08.01.06.0020.001001%Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.001135%Not Available
Muscular weakness15.05.06.001; 17.05.03.0050.004171%
Musculoskeletal pain15.03.04.0070.001568%
Myalgia15.05.02.001--
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.000501%
Myositis15.05.01.0010.000334%
Nausea07.01.07.001--
Neck pain15.03.04.0090.001001%
Neoplasm malignant16.16.01.0010.000834%Not Available
Nerve compression17.09.02.002; 12.01.12.0010.000334%Not Available
Nervous system disorder17.02.10.001--Not Available
Neuralgia17.02.07.0050.001635%
Neuropathy peripheral17.09.03.0030.003437%Not Available
Oedema14.05.06.010; 08.01.07.0060.001168%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oral pain07.05.05.0340.000667%
Osteolysis15.02.03.008; 14.04.04.0060.000334%Not Available
Osteonecrosis24.04.05.004; 15.02.04.0070.000334%
Pain08.01.08.004--
Pain in extremity15.03.04.0100.006407%
Paraesthesia23.03.03.094; 17.02.06.0050.007741%
Paralysis17.01.04.0040.000334%Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Peroneal nerve palsy17.09.02.0030.000901%Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.0160.000734%Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Phlebitis24.12.03.004; 12.02.01.0020.000334%
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