Adverse Drug Reaction Classification System

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 For the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. Also for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Marketing Status Prescription; Discontinued
ATC Code L02BG04
DrugBank ID DB01006
KEGG ID D00964
MeSH ID D000077289
PubChem ID 3902
TTD Drug ID D0C1WH
NDC Product Code 55111-646; 55111-809; 42291-374; 57884-0011; 68554-0039; 71205-587; 0093-7620; 50090-3474; 63592-3376; 16729-034; 51991-759; 63850-7723; 63850-0025; 13808-514; 65096-0116; 0078-0249; 62135-491; 71335-1526; 62756-235; 57884-2021; 59651-180; 69988-0014; 65129-1130; 50268-476; 63850-7701; 63629-7819; 58623-0099
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Cardiovascular disorderAdenylate kinase isoenzyme 1P00568Not Available9456245; 10473018; 14623544; 10514021; 10388095; 9556789; 15814851; 14513432; 11850229; 14687601; 15083379
OsteoporosisAdenylate kinase isoenzyme 1P00568Not Available9456245; 10473018; 14623544; 10514021; 10388095; 9556789; 15814851; 14513432; 11850229; 14687601; 15083379
Urogenital disorderAdenylate kinase isoenzyme 1P00568Not Available9456245; 10473018; 14623544; 10514021; 10388095; 9556789; 15814851; 14513432; 11850229; 14687601; 15083379
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Neoplasm recurrence16.16.02.0040.000481%Not Available
Hepatic lesion09.01.08.0050.001846%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Investigation13.18.01.004--Not Available
Metastasis16.22.01.0010.001926%Not Available
Renal impairment20.01.03.0100.006152%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.002461%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.002461%Not Available
Cardiac septal defect03.07.02.003; 02.04.02.0240.001230%Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.020303%
Loose tooth07.09.05.0090.001230%Not Available
Treatment failure08.06.01.017--Not Available
Liver injury12.01.02.003; 09.01.07.0220.001846%Not Available
Organising pneumonia22.01.02.0080.003691%Not Available
Adverse reaction08.06.01.018--Not Available
Decreased vibratory sense17.02.07.0130.002461%Not Available
Low birth weight baby18.04.02.0030.004922%Not Available
Oestrogenic effect05.05.04.004--Not Available
Brain injury19.07.03.007; 17.11.01.0030.000642%Not Available
Androgenetic alopecia23.02.02.002; 05.05.04.0010.003076%Not Available
Acute kidney injury20.01.03.016--
Drug-induced liver injury12.03.01.044; 09.01.07.0230.002461%Not Available
Adnexal torsion21.11.02.0120.002461%Not Available
Invasive breast carcinoma21.05.01.013; 16.10.01.0050.002461%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.001123%
Liver function test increased13.03.01.044--Not Available
Alopecia areata10.04.02.011; 23.02.02.0080.002461%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.010459%Not Available
Carcinoembryonic antigen increased13.22.01.0090.003076%Not Available
Cartilage injury12.04.03.007; 15.07.03.0050.001846%Not Available
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