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)
Gastrointestinal pain07.01.05.005--
Gingival pain07.09.13.0100.000334%
Haematemesis24.07.02.011; 07.12.02.0020.000334%Not Available
Haematoma24.07.01.0010.001969%
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.001001%
Haemoglobin13.01.05.018--Not Available
Haemolytic anaemia01.06.03.0020.000667%Not Available
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.000334%Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000901%Not Available
Hepatic failure09.01.03.0020.002002%
Hepatic function abnormal09.01.02.0010.001902%Not Available
Hepatitis09.01.07.0040.001168%Not Available
Hepatitis C11.05.28.004; 09.01.09.005--Not Available
Hepatitis cholestatic09.01.01.0020.000334%Not Available
Hepatomegaly09.01.05.0010.000734%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000501%Not Available
Hydronephrosis20.01.05.0010.000334%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000334%
Hyperglycaemia14.06.02.002; 05.06.02.0020.003170%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.007141%
Hypertensive crisis24.08.01.0010.000667%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.009877%Not Available
Hypocalcaemia14.04.01.0040.000501%
Immune system disorder10.02.01.001--Not Available
Impaired healing08.03.02.0010.000734%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site bruising12.07.03.042; 08.02.03.042; 24.07.06.017; 23.03.11.0150.002836%Not Available
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