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)
Ankle fracture15.08.03.005; 12.04.01.0050.001846%
Ankylosing spondylitis10.04.04.004; 15.01.09.0010.003076%Not Available
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.0010.000481%Not Available
Aphasia19.21.01.001; 17.02.03.0010.003076%
Arrhythmia02.03.02.0010.004307%Not Available
Arrhythmia supraventricular02.03.03.0010.003076%Not Available
Arterial thrombosis24.01.01.002--Not Available
Arteriosclerosis24.04.02.0010.000642%Not Available
Arthralgia15.01.02.0010.059678%
Arthritis15.01.01.0010.004307%
Arthropathy15.01.01.0030.006768%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.007998%
Aspartate aminotransferase increased13.03.01.0060.005537%
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.003076%Not Available
Atrial fibrillation02.03.03.0020.010459%
Autoimmune hepatitis09.01.07.019; 10.04.09.0010.001230%Not Available
Axonal neuropathy17.09.03.0150.003691%Not Available
Back pain15.03.04.005--
Basal cell carcinoma23.08.02.001; 16.03.02.0010.003691%Not Available
Blindness17.17.01.003; 06.02.02.0010.003076%Not Available
Blindness unilateral17.17.01.016; 06.02.02.0090.000321%Not Available
Blood bicarbonate decreased13.11.01.0190.001230%
Blood bilirubin increased13.03.01.0080.005537%
Blood cholesterol increased13.12.01.0020.007383%
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood glucose increased13.02.02.002--Not Available
Blood lactate dehydrogenase increased13.04.02.0020.002461%
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