PROLIA for Osteoporosis: Side Effects & Safety Data
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There are 734 adverse event reports in the FDA FAERS database where PROLIA was used for Osteoporosis.
Most Reported Side Effects for PROLIA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 705 | 18.9% | 705 | 20 |
| Pain in extremity | 289 | 7.8% | 0 | 27 |
| Arthralgia | 285 | 7.7% | 0 | 15 |
| Back pain | 228 | 6.1% | 3 | 30 |
| Pain | 220 | 5.9% | 2 | 25 |
| Rash | 157 | 4.2% | 0 | 13 |
| Tooth disorder | 131 | 3.5% | 0 | 3 |
| Bone pain | 130 | 3.5% | 0 | 8 |
| Malaise | 124 | 3.3% | 11 | 38 |
| Myalgia | 116 | 3.1% | 0 | 11 |
| Muscle spasms | 112 | 3.0% | 1 | 17 |
| Fatigue | 104 | 2.8% | 3 | 18 |
| Pruritus | 98 | 2.6% | 1 | 11 |
| Pain in jaw | 97 | 2.6% | 1 | 7 |
| Fall | 93 | 2.5% | 5 | 35 |
Other Indications for PROLIA
Osteoporosis postmenopausal (1,775)
Product used for unknown indication (1,045)
Osteopenia (47)
Senile osteoporosis (39)
Bone loss (20)
Bone disorder (13)
Prophylaxis (10)
Osteoporosis prophylaxis (7)
Osteoporotic fracture (6)
Osteoarthritis (5)
Other Drugs Used for Osteoporosis
TERIPARATIDE (41,596)
DENOSUMAB (31,013)
ZOLEDRONIC ACID (9,860)
ALENDRONATE (7,401)
ABALOPARATIDE (4,420)
ROMOSOZUMAB-AQQG (4,398)
IBANDRONATE (4,121)
RISEDRONATE (2,280)
ALENDRONIC ACID (1,470)
RALOXIFENE (1,432)