Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tamoxifen
Drug ID BADD_D02111
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 D08559
MeSH ID D013629
PubChem ID 2733526
TTD Drug ID D07KSG
NDC Product Code Not Available
UNII 094ZI81Y45
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 C26H29NO
CAS Registry Number 10540-29-1
SMILES CCC(=C(C1=CC=CC=C1)C2=CC=C(C=C2)OCCN(C)C)C3=CC=CC=C3
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)
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vertigo04.04.01.003; 17.02.12.0020.000238%
Vision blurred06.02.06.007; 17.17.01.0100.000523%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000238%
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Vulvovaginal dryness21.08.02.003--
Peripheral swelling02.05.04.015; 08.01.03.053---
General physical health deterioration08.01.03.0180.000238%-
Deep vein thrombosis24.01.02.003---
Malignant neoplasm progression16.16.01.0050.000595%-
Musculoskeletal stiffness15.03.05.0270.000357%-
Musculoskeletal discomfort15.03.04.001---
Pulmonary mass22.02.07.004---
Cutaneous lupus erythematosus10.04.03.007; 15.06.02.007; 23.03.02.008---
Vulvovaginal pruritus21.08.02.004; 23.03.12.009---
Breast cancer female16.10.01.004; 21.05.01.011---
Cognitive disorder17.03.03.003; 19.21.02.001--
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.000713%
Adverse event08.06.01.0100.000809%-
Breast disorder21.05.04.004---
Ocular toxicity06.11.01.006; 12.03.01.0310.000476%-
Genital haemorrhage21.10.05.002; 24.07.03.0070.000238%-
Mental disorder19.07.01.002---
Metastatic neoplasm16.16.01.007---
Neoplasm progression16.16.02.0050.000238%-
Optic nerve disorder06.02.08.001; 17.04.05.004--
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.0070.000238%
Polyp08.01.06.010; 16.02.02.005---
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