Drug Safety Information for AROMASIN (Exemestane)

Safety-related Labeling Changes for AROMASIN (EXEMESTANE) Rx Drug: FDA Link

Adverse Drug Reactions for AROMASIN* (Exemestane)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with AROMASIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Arthralgia*507
2Fatigue*412
3Dyspnoea338
4Neoplasm malignant333
5Death302
6Disease progression294
7Nausea293
8Diarrhoea281
9Breast cancer281
10Pain*277
11Osteonecrosis262
12Headache*213
13Asthenia208
14Pain in extremity*207
15Dizziness197
16Malaise194
17Osteonecrosis of jaw190
18Vomiting189
19Bone pain184
20Back pain173

* This side effect also appears in "Top 10 Side Effects of AROMASIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking AROMASIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Breast cancer*8612
2Breast cancer metastatic2557
3Breast cancer female960
4Product used for unknown indication944
5Breast cancer recurrent247
6Neoplasm malignant231
7Lung neoplasm139
8Pulmonary mass104
9Hormone replacement therapy101
10Ill-defined disorder88

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for AROMASIN

Total Reports Filed with FDA: 31979


Number of FDA Adverse Event Reports by Patient Age for AROMASIN

Total Reports Filed with FDA: 31979*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Exemestane (Aromasine, Aromasin, Aromasil, Exemestane)

Charts are based on 31979 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and AROMASIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.