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.
Marketing Status Prescription
ATC Code L02BA03
DrugBank ID DB00947
KEGG ID D01161
MeSH ID D000077267
PubChem ID 104741
TTD Drug ID D0JO7Y
NDC Product Code 64918-1402; 16714-118; 68001-522; 16729-436; 16714-070; 68001-484; 0310-7720; 70860-211; 71731-6121; 70121-1463; 43598-262; 70710-1688; 66529-0014; 68462-317; 70771-1626; 0591-5019; 72603-105; 50923-0416; 0143-9022; 70534-002; 0781-3492; 67457-311; 63323-715; 25021-462; 53183-9305; 68001-424; 65129-2149; 46439-8769; 59057-003; 61662-0011; 0781-3079; 0310-0720; 71288-555; 69910-0001; 68001-510; 70700-284; 58175-0600
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
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)
Dyspnoea22.02.01.004; 02.01.03.0020.037510%
Dyspnoea at rest02.01.03.007; 22.02.01.0250.001471%Not Available
Embolism venous24.01.01.003--Not Available
Erythema23.03.06.0010.014710%Not Available
Facial paralysis17.04.03.0080.002206%Not Available
Factor VIII deficiency03.15.01.002; 01.01.01.0050.001471%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling hot08.01.09.0090.002942%Not Available
Femoral neck fracture15.08.03.002; 12.04.01.0020.001471%Not Available
Femur fracture12.04.01.003; 15.08.03.0030.008090%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.005884%
Fracture15.08.02.001; 12.04.02.0010.001471%
Fungal infection11.03.05.0010.001471%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.013239%
Gamma-glutamyltransferase increased13.03.01.0110.001471%
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Gingival pain07.09.04.0010.001471%
Haematemesis24.07.02.011; 07.12.02.0020.001471%Not Available
Haematocrit decreased13.01.05.0010.005148%Not Available
Haematoma24.07.01.0010.002206%
Blood urine present13.13.02.0020.001471%Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.001471%Not Available
Hallucination, visual19.10.02.0040.001471%Not Available
Headache17.14.01.001--
Heart rate increased13.14.04.0020.002206%Not Available
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