ADReCS

Pharmaceutical Information

Drug Name	Letrozole
Drug ID	BADD_D01257
Description	Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor first described in the literature in 1990.[A190543,A1559,L11623,L11626] It is a third generation aromatase inhibitor like [exemestane] and [anastrozole], meaning it does not significantly affect cortisol, aldosterone, and thyroxine.[A190546] Letrozole was granted FDA approval on 25 July 1997.[L11623]
Indications and Usage	Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have periviously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer.[L11623] Letrozole, given with ribociclib, is indicated to treat pre, peri, and postmenopausal women with HR+ and human epidermal growth factor 2 (HER2) negative advanced or metastatic breast cancer.[L11626]
Marketing Status	approved; investigational
ATC Code	L02BG04
DrugBank ID	DB01006
KEGG ID	D00964
MeSH ID	D000077289
PubChem ID	3902
TTD Drug ID	D0C1WH
NDC Product Code	58623-0099; 62135-491; 63629-7819; 71205-587; 69988-0014; 50268-476; 68554-0039; 16729-034; 51991-759; 59651-180; 63850-0025; 57884-0011; 65096-0116; 13808-514; 63592-3376; 65129-1130; 0078-0249; 55111-809; 63850-7723; 0093-7620; 42291-374; 71335-1526; 63850-7701; 55111-646
UNII	7LKK855W8I
Synonyms	Letrozole \| 4,4'-(1H-1,2,4-triazol-1-yl-methylene)-bis(benzonitrile) \| CGS 20267 \| CGS-20267 \| CGS20267 \| Femara \| Fémara

Chemical Information

Molecular Formula	C17H11N5
CAS Registry Number	112809-51-5
SMILES	C1=CC(=CC=C1C#N)C(C2=CC=C(C=C2)C#N)N3C=NC=N3
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)
Oestrogenic effect	08.06.01.043; 05.05.04.004	-	-	Not Available
Brain injury	19.07.03.007; 17.11.01.003	0.000395%		Not Available
Androgenetic alopecia	23.02.02.002; 05.05.04.001	0.000659%		Not Available
Acute kidney injury	20.01.03.016	0.003688%
Drug-induced liver injury	12.03.01.044; 09.01.07.023	0.001844%		Not Available
Adnexal torsion	21.11.02.012	0.000395%		Not Available
Hepatic cancer	16.07.02.004; 09.04.02.008	-	-	Not Available
Reversible cerebral vasoconstriction syndrome	18.06.01.004; 17.08.02.014; 24.04.06.026	0.000395%		Not Available
Mouth swelling	10.01.05.020; 23.04.01.020; 07.05.04.007	0.000263%		Not Available
Respiratory symptom	22.12.02.013	0.000527%		Not Available
Invasive breast carcinoma	16.10.01.005; 21.05.01.013	0.000527%		Not Available
Multiple organ dysfunction syndrome	08.01.03.057	0.001054%
Alopecia areata	23.02.02.008; 10.04.02.011	0.001791%		Not Available
Breast cancer recurrent	21.05.01.017; 16.10.01.009	0.002766%		Not Available
Breast cancer stage II	21.05.01.019; 16.10.01.011	0.000263%		Not Available
Concomitant disease aggravated	08.01.03.063	0.000527%		Not Available
Hilar lymphadenopathy	22.09.03.005; 01.09.01.023	0.000790%		Not Available
Jugular vein thrombosis	24.01.02.007	0.000395%		Not Available
Lung adenocarcinoma	22.08.01.007; 16.19.01.002	0.000263%		Not Available
Lymphadenopathy mediastinal	22.09.03.006; 01.09.01.025	0.000527%		Not Available
Malignant ascites	16.32.03.013; 07.07.01.004	0.000263%		Not Available
Malignant pleural effusion	22.05.04.001; 16.32.03.014	0.000790%		Not Available
Metastases to bone	16.22.02.005; 15.09.03.006	0.007771%		Not Available
Metastases to kidney	20.01.04.010; 16.22.02.017	0.000263%		Not Available
Metastases to lymph nodes	16.22.02.006; 01.09.01.015	0.003951%		Not Available
Metastases to pleura	22.05.04.002; 16.22.02.022	0.000263%		Not Available
Metastases to skin	23.07.04.026; 16.22.02.023	0.001317%		Not Available
Metastases to the mediastinum	22.09.03.009; 16.22.02.027	0.000263%		Not Available
Normal newborn	18.08.06.001	-	-	Not Available
Ovarian rupture	21.11.02.018	0.000263%

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