Important Safety Information
Anastrozole is contraindicated in women who are or may become pregnant and in premenopausal women, as it may cause fetal harm and offers no clinical benefit in this population. It is also contraindicated in patients with hypersensitivity to anastrozole or any excipients, with observed reactions including anaphylaxis, angioedema, and urticaria.
Anastrozole should not be used in combination with tamoxifen, as no additional benefit was seen over tamoxifen monotherapy, and the combination may lower anastrozole blood levels.
Important
Non-Medical Use
Non-medical use of anastrozole falls outside approved indications. Product purity does not establish that non-medical use is safe or appropriate for an individual. Estrogen suppression carries risks that may not be apparent without clinical monitoring.
Potential Adverse Effects
Common adverse reactions (incidence ≥10%) in women taking anastrozole include hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, and peripheral edema.
Anastrozole lowers estrogen levels, which may lead to decreased bone mineral density and increased fracture risk. Cholesterol elevations have also been reported. In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed compared to tamoxifen.
Serious adverse reactions occurring in less than 1 in 10,000 patients include skin reactions such as lesions, ulcers, or blisters; allergic reactions with swelling of the face, lips, tongue, and/or throat; and changes in liver function tests.
Conditions Requiring Medical Evaluation
Anastrozole is not appropriate for everyone. Contraindications include pregnancy, premenopausal status, and hypersensitivity to the drug. Caution is advised in patients with pre-existing ischemic heart disease, osteoporosis, or high cholesterol.
Patients should inform their healthcare provider of any heart problems, bone thinning or weakness, high cholesterol, or other medical conditions before taking anastrozole.
Monitoring During Therapy
Medically supervised anastrozole therapy may involve monitoring of bone mineral density, serum cholesterol, and cardiovascular status. In clinical settings, the ATAC trial demonstrated the need for bone density monitoring in patients receiving anastrozole.
Product Care
Storage & Handling
Store tablets in a cool, dry place in the original packaging. Keep out of reach of children. Inspect tablets before use and do not use if they appear damaged or compromised.
Further Safety Information