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)
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.0010.005773%Not Available
Injection site extravasation12.07.03.002; 08.02.03.0020.004304%Not Available
Injection site fibrosis12.07.03.025; 08.02.03.0250.000734%Not Available
Injection site haematoma24.07.01.009; 08.02.03.004; 12.07.03.0040.002302%Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.0050.003404%Not Available
Injection site hypertrophy12.07.03.026; 08.02.03.0260.001135%Not Available
Injection site induration12.07.03.007; 08.02.03.0070.001168%Not Available
Injection site inflammation12.07.03.009; 08.02.03.0080.000501%Not Available
Injection site mass12.07.03.010; 08.02.03.0090.008676%Not Available
Injection site necrosis12.07.03.020; 08.02.03.0200.004371%Not Available
Injection site pain08.02.03.010; 12.07.03.0110.032000%Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.0130.002603%Not Available
Injection site rash23.03.13.010; 12.07.03.032; 08.02.03.0320.001301%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.004405%
Injection site ulcer23.07.03.012; 12.07.03.017; 08.02.03.0160.001235%Not Available
Injection site vesicles23.03.01.024; 12.07.03.051; 08.02.03.0510.001468%Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.002836%Not Available
Intestinal perforation07.04.06.0020.000334%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000834%Not Available
Lacrimation increased06.08.02.0040.000734%
Laryngeal oedema23.04.01.005; 10.01.05.003; 22.04.02.0010.000334%
Laryngospasm22.04.02.0020.001235%
Leukopenia01.02.02.001--Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000501%Not Available
Lymphoedema24.09.01.001; 01.09.01.0060.000734%
Mass08.03.05.0030.002836%Not Available
Menopausal symptoms21.02.02.002--Not Available
Metastases to liver09.04.02.004; 16.22.02.0010.005506%Not Available
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