DENOSUMAB for Osteoporosis: Side Effects & Safety Data
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There are 31,013 adverse event reports in the FDA FAERS database where DENOSUMAB was used for Osteoporosis.
Most Reported Side Effects for DENOSUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 34,612 | 23.2% | 299 | 730 |
| Death | 16,545 | 11.1% | 16,459 | 663 |
| Osteonecrosis of jaw | 8,438 | 5.7% | 303 | 1,486 |
| Arthralgia | 5,890 | 4.0% | 51 | 557 |
| Pain in extremity | 4,541 | 3.1% | 52 | 530 |
| Back pain | 4,465 | 3.0% | 95 | 515 |
| Pain | 4,102 | 2.8% | 97 | 566 |
| Product storage error | 3,621 | 2.4% | 1 | 31 |
| Fall | 3,322 | 2.2% | 159 | 1,156 |
| Fatigue | 3,009 | 2.0% | 189 | 661 |
| Myalgia | 2,965 | 2.0% | 28 | 268 |
| Bone pain | 2,805 | 1.9% | 38 | 255 |
| Spinal fracture | 2,566 | 1.7% | 58 | 323 |
| Tooth disorder | 2,553 | 1.7% | 13 | 128 |
| Hypocalcaemia | 2,345 | 1.6% | 237 | 1,313 |
Other Indications for DENOSUMAB
Product used for unknown indication (58,522)
Osteoporosis postmenopausal (18,350)
Bone disorder (13,297)
Metastases to bone (5,083)
Prophylaxis (4,541)
Osteopenia (2,402)
Prostate cancer (1,627)
Osteoporotic fracture (1,583)
Breast cancer (1,576)
Breast cancer metastatic (1,444)
Other Drugs Used for Osteoporosis
TERIPARATIDE (41,596)
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)
IBANDRONIC ACID (820)