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)
Pleural effusion22.05.02.0020.002736%
Pneumothorax22.05.02.0030.000667%
Portal vein thrombosis09.01.06.007; 24.01.03.0030.000501%
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.002202%
Pruritus23.03.12.001--
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.000501%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.0010.003170%Not Available
Pulmonary fibrosis22.01.02.0060.000334%
Pyoderma gangrenosum23.07.03.001; 16.32.03.005; 10.04.02.0090.000334%Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash erythematous23.03.13.0290.001301%Not Available
Respiratory disorder22.02.07.0020.001235%Not Available
Respiratory distress22.02.01.0120.000901%Not Available
Sciatica17.10.03.001; 15.10.01.0010.001702%Not Available
Skin disorder23.03.03.007--Not Available
Skin odour abnormal23.03.03.0120.001702%
Skin reaction23.03.03.013; 10.01.03.0190.000334%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.001135%
Speech disorder17.02.08.003; 22.12.03.027; 19.19.02.0020.001068%Not Available
Swelling08.01.03.0150.003270%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.002202%Not Available
Tenderness08.01.08.0050.000334%Not Available
Therapeutic response decreased08.06.01.0160.000667%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.007641%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.004405%Not Available
Thrombocytopenia01.08.01.0020.002336%Not Available
Thrombotic thrombocytopenic purpura01.08.01.005; 24.07.06.014; 23.06.01.0110.000334%
Tumour flare16.32.03.0010.000501%Not Available
Tumour pain16.32.03.0030.000334%
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