What the label lists and what reports show
Exemestane side effects
Exemestane's FDA label: “Most common adverse reactions were mild to moderate and included hot flushes (13% vs.” FAERS holds 21,298 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,261 reports).
- Generic listed
Check it at the source: the exemestane FDA label on DailyMed (effective September 12, 2024, Breckenridge Pharmaceutical, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of exemestane tablets?Exemestane tablets may cause serious side effects, including: Bone loss. Exemestane tablets decreases the amount of estrogen in your body which may reduce your bone mineral density (BMD) over time. This may increase your risk for bone fractures or weak and brittle bones (osteoporosis). Your doctor may check your bones during treatment with exemestane tablets if you have osteoporosis or at risk for osteoporosis. The most common side effects of exemestane tablets in women with early breast cancer include: hot flashes headache feeling tired trouble sleeping joint pain increased sweating The most common side effects of exemestane tablets in women with advanced breast cancer include: hot flashes increased sweating nausea increased appetite feeling tired Your doctor will do blood tests to check your vitamin D level before starting treatment with exemestane tablets. […]
Source: FDA drug label, Breckenridge Pharmaceutical, Inc., effective September 12, 2024 (SPL set 4e3fd382-19f5-4ded-ab22-39d5b1b2f366), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions were mild to moderate and included hot flushes (13% vs.
Table 4. Incidence (%) of Adverse Reactions of all Grades Graded according to Common Toxicity Criteria and Causes Occurring in ≥5% of Advanced Breast Cancer Patients In Each Treatment Arm in the Comparative Study
| Reaction | Exemesane Tablets 25 mg once daily (N=358) | Megestrol Acetate 40 mg QID (N=400) |
|---|---|---|
| Increased sweating | 6 | 9 |
| Fatigue | 22 | 29 |
| Hot flashes | 13 | 6 |
| Pain | 13 | 13 |
| Influenza-like symptoms | 6 | 5 |
| Edema (includes edema, peripheral edema, leg edema) | 7 | 6 |
| Hypertension | 5 | 6 |
| Depression | 13 | 9 |
| Insomnia | 11 | 9 |
| Anxiety | 10 | 11 |
| Dizziness | 8 | 6 |
| Headache | 8 | 7 |
| Nausea | 18 | 12 |
| Vomiting | 7 | 4 |
| Abdominal pain | 6 | 11 |
| Anorexia | 6 | 5 |
| Constipation | 5 | 8 |
| Diarrhea | 4 | 5 |
| Increased appetite | 3 | 6 |
| Dyspnea | 10 | 15 |
| Coughing | 6 | 7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. 10%). Discontinuation rates due to AEs were similar between exemestane tablets and tamoxifen (6% vs. 5%). 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 ). Advanced breast cancer: Most common adverse reactions were mild to moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%) for exemestane tablets and megestrol acetate, respectively ( 6 , 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Breckenridge Pharmaceutical, Inc., effective September 12, 2024 (SPL set 4e3fd382-19f5-4ded-ab22-39d5b1b2f366), via openFDA; the full label on DailyMed
What do FAERS reports show?
21,298 reports list exemestane among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,512 are coded as a death and 5,287 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Exemestane: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions