Apalutamide

Common brands: Erleada, Orgovyx, Eligard, Aspirin 325, Aspirin 81

Top reporter: Janssen Products, Lp

Gonadotropin Releasing Hormone Receptor Antagonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]Corticosteroid [EPC]Androgen Receptor Inhibitor [EPC]
11,281
Total Reports
8,360
Serious Reports
1,486
Death Reports
30
Reported Reactions
Death Report Ratio: High (13.17%)

Patient Demographics

Male
9,564
Female
40

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Apalutamide.

# Reaction Reports % of Total
1 RASH 1,229
11.2%
2 DEATH 1,165
10.6%
3 FATIGUE 1,130
10.3%
4 HOT FLUSH 846
7.7%
5 PRODUCT DOSE OMISSION ISSUE 436
4.0%
6 ASTHENIA 420
3.8%
7 DIARRHOEA 391
3.6%
8 DIZZINESS 359
3.3%
9 OFF LABEL USE 352
3.2%
10 ARTHRALGIA 338
3.1%
11 FALL 323
2.9%
12 DECREASED APPETITE 304
2.8%
13 PROSTATIC SPECIFIC ANTIGEN INCREASED 301
2.7%
14 INCORRECT DOSE ADMINISTERED 282
2.6%
15 PRURITUS 270
2.5%
16 DRUG INEFFECTIVE 245
2.2%
17 NAUSEA 237
2.2%
18 WEIGHT DECREASED 236
2.1%
19 HOSPITALISATION 233
2.1%
20 HYPERTENSION 216
2.0%
21 DYSPNOEA 204
1.9%
22 DRUG INTERACTION 203
1.8%
23 INSOMNIA 181
1.6%
24 PAIN 178
1.6%
25 MALAISE 165
1.5%
26 BACK PAIN 157
1.4%
27 HEADACHE 157
1.4%
28 THERAPY CESSATION 156
1.4%
29 PAIN IN EXTREMITY 149
1.4%
30 CONSTIPATION 148
1.3%

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.