Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling.
Bone effects [see Warnings and Precautions ( 5.1 )] Increases in cholesterol [see Warnings and Precautions ( 5.2 )] Fatigue and Dizziness [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (greater than 20%) were hot flashes, arthralgia;
flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain and musculoskeletal ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc.
at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adjuvant Treatment of Early Breast Cancer In study, BIG 1-98, the median treatment duration of adjuvant treatment was 60 months and the median duration of follow-up for safety was 96 months for patients receiving letrozole and tamoxifen.
Certain adverse reactions were prospectively specified for analysis (see Table 1), based on the known pharmacologic properties and side effect profiles of the two drugs.
Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline.
Most adverse reactions reported (approximately 75% of patients who reported AEs) were Grade 1 or Grade 2 applying the Common Toxicity Criteria (CTC) Version 2.0/ Common Terminology Criteria for Adverse Events (CTCAE), Version 3.
5 WARNINGS AND PRECAUTIONS Decreases in bone mineral density may occur.
Consider bone mineral density monitoring ( 5.1 ) Increases in total cholesterol may occur.
Consider cholesterol monitoring.
( 5.2 ) Fatigue, dizziness and somnolence may occur.
Exercise caution when operating machinery ( 5.4 ) Embryo-Fetal toxicity: Can cause fetal harm when administered to pregnant women.
Like all medications, Letrozole can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: