DENOSUMAB for Prophylaxis: Side Effects & Safety Data
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There are 4,541 adverse event reports in the FDA FAERS database where DENOSUMAB was used for Prophylaxis.
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 (31,013)
Osteoporosis postmenopausal (18,350)
Bone disorder (13,297)
Metastases to bone (5,083)
Osteopenia (2,402)
Prostate cancer (1,627)
Osteoporotic fracture (1,583)
Breast cancer (1,576)
Breast cancer metastatic (1,444)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)
ATORVASTATIN (1,253)