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 clinically significant adverse reactions are described elsewhere in the labeling: Reductions in Bone Mineral Density (BMD) [see Warnings and Precautions (5.1) ] Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (exemestane tablets vs.
tamoxifen) were hot flushes (21% vs.
20%), fatigue (16% vs.
15%), arthralgia (15% vs.
9%), headache (13% vs.
11%), insomnia (12% vs.
9%), and increased sweating (12% vs.
Discontinuation rates due to AEs were similar between exemestane tablets and tamoxifen (6% vs.
Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were exemestane tablets 1.6%, tamoxifen 0.6%.
Incidence of cardiac failure: exemestane tablets 0.4%, tamoxifen 0.3% ( 6 , 6.1 ).
5 WARNINGS AND PRECAUTIONS Reductions in bone mineral density (BMD) over time are seen with exemestane use ( 5.1 ).
Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed ( 5.2 ).
Embryo-Fetal Toxicity: Can cause fetal harm.
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.6 , 8.1 , 8.3 ).
5.1 Reductions in Bone Mineral Density (BMD) Reductions in bone mineral density (BMD) over time are seen with exemestane use.
Like all medications, Exemestane 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: