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)
Hepatic cirrhosis09.01.04.0010.000576%Not Available
Hepatic failure09.01.03.0020.001343%
Hepatic function abnormal09.01.02.0010.003677%Not Available
Hepatitis09.01.07.0040.001471%Not Available
Hepatitis C11.05.06.004; 09.01.09.005--Not Available
Herpes zoster23.09.03.002; 11.05.02.003--
Hip fracture15.08.03.001; 12.04.01.0010.002206%
Hydronephrosis20.01.05.0010.001471%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.005148%
Hyperhidrosis23.02.03.004; 08.01.03.0280.005884%
Hypersensitivity10.01.03.0030.013239%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.0230.016916%Not Available
Hypocalcaemia14.04.01.0040.002206%
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.010--
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.004--Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease10.02.01.033; 22.01.02.0030.006619%Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.001471%Not Available
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