Bicalutamide

Common brands: Casodex, Eligard, Xtandi, Lupron Depot, Ecotrin

Top reporter: Ani Pharmaceuticals, Inc.

Androgen Receptor Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Platelet Aggregation Inhibitor [EPC]Loop Diuretic [EPC]
15,037
Total Reports
5,644
Serious Reports
2,698
Death Reports
30
Reported Reactions
Death Report Ratio: High (17.94%)

Patient Demographics

Male
13,812
Female
175

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Bicalutamide.

# Reaction Reports % of Total
1 FATIGUE 1,318
8.3%
2 DEATH 982
6.1%
3 PROSTATIC SPECIFIC ANTIGEN INCREASED 936
5.9%
4 ASTHENIA 803
5.0%
5 HOT FLUSH 784
4.9%
6 PROSTATE CANCER 751
4.7%
7 MALIGNANT NEOPLASM PROGRESSION 712
4.5%
8 DRUG INEFFECTIVE 606
3.8%
9 DIZZINESS 578
3.6%
10 NAUSEA 561
3.5%
11 DYSPNOEA 540
3.4%
12 DIARRHOEA 525
3.3%
13 DECREASED APPETITE 510
3.2%
14 ANAEMIA 493
3.1%
15 METASTASES TO BONE 425
2.7%
16 OFF LABEL USE 425
2.7%
17 FALL 423
2.6%
18 PAIN 407
2.5%
19 BACK PAIN 392
2.5%
20 PNEUMONIA 392
2.5%
21 ARTHRALGIA 375
2.3%
22 CONSTIPATION 374
2.3%
23 WEIGHT DECREASED 374
2.3%
24 MALAISE 366
2.3%
25 INTERSTITIAL LUNG DISEASE 365
2.3%
26 DISEASE PROGRESSION 338
2.1%
27 PYREXIA 326
2.0%
28 CONFUSIONAL STATE 309
1.9%
29 DRUG INTERACTION 289
1.8%
30 PROSTATE CANCER METASTATIC 289
1.8%

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.