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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.006152%
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.001846%Not Available
Abnormal weight gain14.03.02.0100.002461%Not Available
Abortion18.01.01.0010.003076%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.001846%Not Available
Acne23.02.01.001--Not Available
Activated partial thromboplastin time prolonged13.01.02.0010.001230%
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.0060.003076%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.001123%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory failure14.01.04.004; 22.02.06.0010.000481%Not Available
Adenocarcinoma16.16.01.0040.000321%Not Available
Ageusia17.02.07.001; 07.14.03.0030.001230%Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.0030.004922%
Alopecia23.02.02.0010.020303%
Amnesia19.20.01.001; 17.03.02.0010.006152%
Amyotrophic lateral sclerosis17.05.05.0040.001230%Not Available
Anaemia01.03.02.0010.019688%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.001846%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
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