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. 2011 Dec 1;3:79–91. doi: 10.2147/DHPS.S7727

Table 2.

The five most common “adverse reactions” of denosumab from the pivotal fracture trial in women with postmenopausal osteoporosis that occurred in 2% or more of patients treated with denosumab and were more frequent than in placebo-treated subjects42

Adverse reaction Denosumab (n = 3886) Placebo (n = 3876)
Back pain 1347 (34.7%) 1340 (34.6%)
Pain in extremity 453 (11.7%) 430 (11.1%)
Musculoskeletal pain 297 (7.65) 291 (7.5%)
Hypercholesterolemia 280 (7.2%) 236 (6.1%)
Cystitis 228 (5.9%) 225 (5.8%)

Notes: These are listed as “side effects” of denosumab in the Prolia® medication guide43 without explanation regarding statistical significance, causality, or clinical relevance. These untoward medical occurrences are those that are common in elderly populations, with the differences in incidence between the two groups being very small.