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 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)
Epistaxis24.07.01.005; 22.04.03.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Erythema nodosum23.07.02.001; 10.02.01.0200.000395%Not Available
Eye disorder06.08.03.0010.002160%Not Available
Eye irritation06.04.05.003--Not Available
Eyelid oedema10.01.05.001; 23.04.01.003; 06.04.04.0040.000263%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.000395%
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.0020.001054%
Feeling abnormal08.01.09.014--Not Available
Feeling hot08.01.09.009--Not Available
Flatulence07.01.04.0020.001106%
Flushing08.01.03.025; 24.03.01.002; 23.06.05.003--
Fracture15.08.02.001; 12.04.02.001--
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.003214%
Gastritis erosive07.04.03.0030.000263%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.000263%
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Glaucoma06.03.01.0020.000527%
Glossodynia07.14.02.0010.000580%Not Available
Gravitational oedema08.01.07.005; 02.05.04.014--Not Available
Groin pain15.03.02.0040.000527%Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.0050.000263%
Haemoconcentration01.05.01.0080.001054%Not Available
Haemoglobin13.01.05.018--Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.001106%Not Available
Haemorrhagic stroke24.07.04.014; 17.08.01.0110.000395%Not Available
Headache17.14.01.001--
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ADReCS-Target
Drug Name ADR Term Target
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