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)
Thrombosis24.01.01.006--Not Available
Tumour flare16.32.03.001--Not Available
Tumour pain16.32.03.003--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine cancer21.07.02.003; 16.12.05.001--Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.001--Not Available
Uterine polyp21.07.02.001; 16.04.02.002--Not Available
Vaginal discharge21.08.02.002--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vaginal infection21.14.02.002; 11.01.10.002--
Vasculitis24.12.04.027; 10.02.02.006--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Venous thrombosis24.01.01.008--Not Available
Visual acuity reduced17.17.01.011; 06.02.10.012--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Vulvovaginal dryness21.08.02.003--
Vulvovaginitis21.14.02.005; 11.01.10.003--Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Wrist fracture15.08.03.007; 12.04.01.008--
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Deep vein thrombosis24.01.02.003--Not Available
Acute coronary syndrome02.02.02.015; 24.04.04.011--Not Available
Albright's disease15.11.01.002; 05.05.03.004; 03.11.01.002; 23.05.01.007; 21.03.02.020--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Walking disability26.01.01.009--Not Available
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