Drug Safety Information for XTANDI (Enzalutamide)

FDA Safety-related Labeling Changes for XTANDI (ENZALUTAMIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

Collect and analyze all cases of new (non-prostate) malignancies identified in patients treated with XTANDI� (enzalutamide) on an annual basis. These interim reports should summarize all cases identified up until that reporting date (new cases and those reported in previous years) and should include patients treated with XTANDI� on clinical trials and outside of clinical trials (including spontaneous safety reports) to provide an accurate assessment of the long-term incidence and risk of new (non-prostate) malignancies in patients treated with XTANDI�. Due Date: 2024-10-31

Required post-approval safety study:

Submit the Overall Survival analyses and datasets with the final report of clinical trial PROSPER entitled ""A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Enzalutamide in Patients With Non-metastatic Castration-Resistant Prostate Cancer"". Due Date: 2021-09-30

Original FDA Drug Approval Date for XTANDI: 2012-08-31

Adverse Drug Reactions for XTANDI* (Enzalutamide)

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 XTANDI
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	1498
2	Fatigue	1472
3	Neoplasm malignant	1198
4	Drug ineffective	993
5	Nausea	623
6	Prostatic specific antigen increased	612
7	Asthenia	553
8	Decreased appetite	542
9	Diarrhoea	427
10	Dizziness	419
11	Back pain	357
12	Hot flush	282
13	Malaise	279
14	Dysphagia	278
15	Arthralgia	274
16	Vomiting	262
17	Underdose	245
18	Hospitalisation	233
19	Weight decreased	229
20	Insomnia	225

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

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

	Reason	# of FDA Reports
1	Prostate cancer	14177
2	Product used for unknown indication	5579
3	Prostate cancer metastatic	2839
4	Neoplasm malignant	266
5	Neoplasm prostate	222
6	Bone neoplasm malignant	111
7	Prostate cancer stage iv	68
8	Prostatic specific antigen increased	68
9	Pancreatic carcinoma	67
10	Prostate cancer recurrent	41

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

Types of Adverse Events for XTANDI

Total Reports Filed with FDA: 24354

Number of FDA Adverse Event Reports by Patient Age for XTANDI

Total Reports Filed with FDA: 24354*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Enzalutamide (Xtandi)

Charts are based on 24354 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.

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.