Drug Safety Information for ARIMIDEX (Anastrozole)

FDA Safety-related Labeling Changes for ARIMIDEX (ANASTROZOLE) Rx Drug: Safety Information Link

Adverse Drug Reactions for ARIMIDEX* (Anastrozole)

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 ARIMIDEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Arthralgia*1481
2Hot flush*836
3Fatigue*767
4Pain in extremity662
5Nausea652
6Pain*648
7Headache541
8Insomnia*497
9Asthenia494
10Bone pain472
11Depression*466
12Weight increased*457
13Alopecia*453
14Dizziness448
15Fall428
16Dyspnoea426
17Myalgia407
18Back pain406
19Arthritis403
20Breast cancer402

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

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

Reason # of FDA Reports
1Breast cancer*20971
2Breast cancer female3040
3Product used for unknown indication1889
4Breast cancer metastatic*1132
5Neoplasm malignant558
6Breast cancer stage i*366
7Breast cancer recurrent289
8Prophylaxis216
9Breast cancer stage ii*193
10Metastases to bone191

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


Types of Adverse Events for ARIMIDEX

Total Reports Filed with FDA: 62475


Number of FDA Adverse Event Reports by Patient Age for ARIMIDEX

Total Reports Filed with FDA: 62475*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Anastrozole (Anastrozole, Arimidex)

Charts are based on 62475 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 ARIMIDEX 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.