Anastrozole: Side Effects, Uses & Monitoring
1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
- Data source
- FDA labeling via NIH DailyMed (label 8270c509…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Gastrointestinal disturbance | 81% |
| Nausea | 48% |
| Asthenia | 47% |
| Headache | 44% |
| Pain | 38% |
| Weight gain | 30% |
| Back pain | 28% |
| Peripheral edema | 28% |
| Vomiting | 26% |
| Bone pain | 26% |
| Dyspnea | 24% |
| Pharyngitis | 23% |
| Cough increased | 22% |
| Diarrhea | 22% |
| Constipation | 21% |
| Coronary and cerebral ‡ | 19% |
| Anorexia | 19% |
| Rash | 19% |
| Abdominal pain | 18% |
| Chest pain | 18% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. 1.3 Second-Line Treatment Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
Conditions associated with Anastrozole in labeling
Frequently Asked Questions
What is Anastrozole used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Anastrozole?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Anastrozole. Individual risk varies.
Does Anastrozole require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Anastrozole.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.