Denosumab

Common brands: Prolia, Xgeva, Jubbonti, Wyost, Bildyos

Top reporter: Amgen, Inc

RANK Ligand Inhibitor [EPC]Provitamin D2 Compound [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Calcium [EPC]
198,109
Total Reports
63,625
Serious Reports
25,330
Death Reports
30
Reported Reactions
Death Report Ratio: High (12.79%)

Patient Demographics

Male
28,376
Female
147,308

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Denosumab.

# Reaction Reports % of Total
1 OFF LABEL USE 36,585
20.3%
2 DEATH 20,086
11.1%
3 ARTHRALGIA 8,763
4.9%
4 OSTEONECROSIS OF JAW 8,521
4.7%
5 FATIGUE 7,590
4.2%
6 PAIN IN EXTREMITY 6,950
3.9%
7 PAIN 6,838
3.8%
8 BACK PAIN 6,822
3.8%
9 NAUSEA 5,374
3.0%
10 DIARRHOEA 5,216
2.9%
11 FALL 5,037
2.8%
12 RASH 4,268
2.4%
13 MYALGIA 4,202
2.3%
14 ASTHENIA 4,009
2.2%
15 BONE PAIN 4,009
2.2%
16 PRODUCT STORAGE ERROR 3,673
2.0%
17 DYSPNOEA 3,662
2.0%
18 MALAISE 3,634
2.0%
19 HEADACHE 3,627
2.0%
20 HYPOCALCAEMIA 3,287
1.8%
21 TOOTH DISORDER 3,198
1.8%
22 DRUG INEFFECTIVE 3,156
1.7%
23 DIZZINESS 2,956
1.6%
24 PRURITUS 2,920
1.6%
25 SPINAL FRACTURE 2,848
1.6%
26 PAIN IN JAW 2,671
1.5%
27 PNEUMONIA 2,659
1.5%
28 VOMITING 2,634
1.5%
29 WEIGHT DECREASED 2,592
1.4%
30 URINARY TRACT INFECTION 2,588
1.4%

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.