Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tamoxifen citrate
Drug ID BADD_D02112
Description Tamoxifen is a non-steroidal antiestrogen used to treat estrogen receptor positive breast cancers as well as prevent the incidence of breast cancer in high risk populations.[A1025,L7799,L7802] Tamoxifen is used alone or as an adjuvant in these treatments.[L7799,L7802] Tamoxifen may no longer be the preferred treatment for these types of cancers as patients generally have better survival, side effect profiles, and compliance with [anastrozole].[A1026] Tamoxifen was granted FDA approval on 30 December 1977.[L7799]
Indications and Usage Tamoxifen is indicated to treat estrogen receptor positive metastatic breast cancer in adults, as an adjuvant in the treatment of early stage estrogen receptor positive breast cancer in adults, to reduce the risk of invasive breast cancer after surgery and radiation in adult women with ductal carcinoma in situ.[L7802]
Marketing Status approved
ATC Code L02BA01
DrugBank ID DB00675
KEGG ID D00966
MeSH ID D013629
PubChem ID 2733525
TTD Drug ID D07KSG
NDC Product Code 65319-1151; 51407-440; 51862-642; 0378-0274; 17337-0035; 46014-1015; 46014-1190; 49452-7571; 51927-5076; 63275-9865; 59651-299; 70518-2721; 70771-1185; 46014-1200; 51862-682; 70771-1184; 51552-0838; 51862-643; 51407-439; 68382-826; 36974-0048; 0378-0144; 51927-2976; 63187-976; 0591-2472; 17337-0034; 50090-0485; 59651-300; 68382-827; 46014-1180; 63739-143; 68071-5254; 0591-2473; 65319-1051
UNII 7FRV7310N6
Synonyms Tamoxifen | ICI-47699 | ICI 47699 | ICI47699 | Nolvadex | Novaldex | Tamoxifen Citrate | Citrate, Tamoxifen | Tomaxithen | Zitazonium | ICI-46474 | ICI 46474 | ICI46474 | ICI-46,474 | ICI 46,474 | ICI46,474 | Soltamox
Chemical Information
Molecular Formula C32H37NO8
CAS Registry Number 54965-24-1
SMILES CCC(=C(C1=CC=CC=C1)C2=CC=C(C=C2)OCCN(C)C)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O) O
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)
Haemorrhage24.07.01.002--Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.007--Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.004--Not Available
Precocious puberty05.05.03.001; 21.03.02.009--
Urine output13.13.03.003--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Ischaemic cerebral infarction24.04.06.013; 17.08.01.022--Not Available
Benign neoplasm16.02.02.007--Not Available
Breast cancer male21.05.01.008; 16.10.01.002--Not Available
Ocular toxicity12.03.01.031; 06.11.01.006--Not Available
Embolism24.01.01.009--
Inflammation10.02.01.089; 08.01.05.007--Not Available
Metastatic neoplasm16.16.01.007--Not Available
Optic nerve disorder06.02.08.001; 17.04.05.004--
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Polyp16.02.02.005; 08.01.06.010--Not Available
Disease progression08.01.03.038--
Hyperlipidaemia14.08.03.001--
Bone marrow failure01.03.03.005--
Liver injury09.01.07.022; 12.01.17.012--Not Available
Oestrogenic effect08.06.01.043; 05.05.04.004--Not Available
Accidental exposure to product12.09.01.001--Not Available
Liver function test increased13.03.04.031--Not Available
Vulvovaginal inflammation21.14.02.014--Not Available
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