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)
Concomitant disease aggravated08.01.03.0630.002461%Not Available
Congenital umbilical hernia07.16.03.003; 03.04.07.0060.001230%Not Available
Full blood count decreased13.01.07.004--Not Available
Hilar lymphadenopathy22.09.03.005; 01.09.01.0230.001230%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.001846%Not Available
Malignant ascites16.32.03.013; 07.07.01.0040.000321%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000802%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.007383%Not Available
Metastases to kidney20.01.04.010; 16.22.02.0170.000321%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.002247%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000321%Not Available
Metastases to skin16.22.02.023; 23.07.04.0260.003691%Not Available
Metastases to the mediastinum22.09.03.009; 16.22.02.0270.001230%Not Available
Portal shunt09.01.06.023; 24.08.06.0070.000802%Not Available
Purulent discharge11.01.08.061; 08.01.03.0760.001846%Not Available
Recurrent cancer16.16.01.0150.002461%Not Available
Systemic sclerosis07.11.02.008; 24.03.03.041; 23.03.02.021; 15.06.01.019; 10.04.07.0060.000642%Not Available
Toxic nodular goitre05.02.02.007; 14.11.01.0470.001230%Not Available
Brain malformation17.19.01.008; 03.10.02.0080.001230%Not Available
Tumour marker increased13.22.01.0170.006152%Not Available
Concomitant disease progression08.01.03.0640.000481%Not Available
Subclavian vein thrombosis24.01.02.0130.001230%Not Available
Live birth18.08.02.0070.001230%Not Available
Carbohydrate antigen 15-3 increased13.22.01.0060.002461%Not Available
Primary sequestrum15.02.04.0380.001230%Not Available
Lymphangiosis carcinomatosa16.22.02.009; 01.09.01.027; 24.09.02.0070.000321%Not Available
Bone swelling15.02.01.0060.001230%Not Available
Congenital cerebral cyst03.10.03.003; 17.18.05.003; 16.09.05.0030.000481%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.005296%Not Available
Tenosynovitis stenosans15.04.02.0050.000802%Not Available
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