DENOSUMAB for Osteoporotic fracture: Side Effects & Safety Data

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There are 1,583 adverse event reports in the FDA FAERS database where DENOSUMAB was used for Osteoporotic fracture.

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