PROLIA for Bone loss: Side Effects & Safety Data
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There are 20 adverse event reports in the FDA FAERS database where PROLIA was used for Bone loss.
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)
Osteoporosis (734)
Osteopenia (47)
Senile osteoporosis (39)
Bone disorder (13)
Prophylaxis (10)
Osteoporosis prophylaxis (7)
Osteoporotic fracture (6)
Osteoarthritis (5)
Other Drugs Used for Bone loss
DENOSUMAB (302)
ALENDRONATE (98)
IBANDRONATE (54)
ZOLEDRONIC ACID (44)
TERIPARATIDE (37)
RISEDRONATE (35)
ALENDRONIC ACID (12)
FOSAMAX (11)
ESTROGENS, CONJUGATED (9)
RALOXIFENE (9)