Enzalutamide

Common brands: Xtandi, Prednisone, Prednisone Delayed Release, Prednisone Tablets, Usp, 10 Mg, Prednisone Tablets, Usp, 20 Mg

Top reporter: Astellas Pharma Us, Inc.

Androgen Receptor Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Platelet Aggregation Inhibitor [EPC]RANK Ligand Inhibitor [EPC]
58,003
Total Reports
20,804
Serious Reports
11,324
Death Reports
30
Reported Reactions
Death Report Ratio: High (19.52%)

Patient Demographics

Male
55,293
Female
363

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Enzalutamide.

# Reaction Reports % of Total
1 FATIGUE 10,208
12.6%
2 DEATH 7,681
9.5%
3 MALIGNANT NEOPLASM PROGRESSION 5,440
6.7%
4 PROSTATIC SPECIFIC ANTIGEN INCREASED 4,325
5.3%
5 ASTHENIA 4,137
5.1%
6 DRUG INEFFECTIVE 4,043
5.0%
7 HOT FLUSH 3,850
4.7%
8 DECREASED APPETITE 3,394
4.2%
9 NAUSEA 3,247
4.0%
10 DIZZINESS 3,124
3.9%
11 DIARRHOEA 2,790
3.4%
12 BACK PAIN 2,290
2.8%
13 ARTHRALGIA 2,137
2.6%
14 UNDERDOSE 2,073
2.6%
15 CONSTIPATION 1,817
2.2%
16 FALL 1,811
2.2%
17 WEIGHT DECREASED 1,779
2.2%
18 PAIN 1,714
2.1%
19 HEADACHE 1,656
2.0%
20 MALAISE 1,568
1.9%
21 DYSPNOEA 1,494
1.8%
22 INSOMNIA 1,357
1.7%
23 PERIPHERAL SWELLING 1,324
1.6%
24 DYSPHAGIA 1,299
1.6%
25 VOMITING 1,257
1.6%
26 PAIN IN EXTREMITY 1,218
1.5%
27 OFF LABEL USE 1,036
1.3%
28 SOMNOLENCE 1,009
1.2%
29 MUSCULAR WEAKNESS 1,006
1.2%
30 ABDOMINAL DISCOMFORT 984
1.2%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.