Drug Safety Information for CASODEX (Bicalutamide)

Safety-related Labeling Changes for CASODEX (BICALUTAMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for CASODEX* (Bicalutamide)

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 CASODEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Prostate cancer277
2Dyspnoea259
3Fatigue*254
4Death240
5Neoplasm malignant231
6Asthenia230
7Prostatic specific antigen increased222
8Interstitial lung disease216
9Anaemia189
10Pain189
11Nausea186
12Decreased appetite175
13Dizziness174
14Back pain158
15Osteonecrosis147
16Pneumonia146
17Metastases to bone146
18Pyrexia145
19Hot flush*145
20Osteonecrosis of jaw144

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

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

Reason # of FDA Reports
1Prostate cancer*6773
2Product used for unknown indication1930
3Prostate cancer stage iv541
4Prostate cancer metastatic497
5Prostate cancer stage ii317
6Prostatic specific antigen increased175
7Prostate cancer stage iii174
8Antiandrogen therapy114
9Neoplasm malignant95
10Prostatic disorder63

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


Types of Adverse Events for CASODEX

Total Reports Filed with FDA: 25156


Number of FDA Adverse Event Reports by Patient Age for CASODEX

Total Reports Filed with FDA: 25156*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bicalutamide (Cosudex, Casodex, Bicalutamide)

Charts are based on 25156 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 CASODEX 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.