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)
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haemoglobin13.01.05.018--Not Available
Headache17.14.01.001--
Hepatic cyst16.06.02.001; 09.01.08.008--Not Available
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001--Not Available
Hepatic necrosis09.01.07.002--
Hepatic steatosis09.01.07.003; 14.08.04.005--Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.008--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
High density lipoprotein decreased13.12.01.003--Not Available
Hip fracture15.08.03.001; 12.04.01.001--
Hypercalcaemia14.04.01.003; 05.04.01.002--
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperplasia08.03.04.008--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Ichthyosis acquired23.01.02.001--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Joint swelling15.01.02.004--Not Available
Leukopenia01.02.02.001--Not Available
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