In the FREEDOM trial, conducted in osteoporotic postmenopausal women against placebo, the most frequently reported effects were close to those of placebo: back pain 34.7 percent versus 34.6, pain in the extremities 11.7 versus 11.1, musculoskeletal pain 7.6 versus 7.5, hypercholesterolaemia 7.2 versus 6.1, cystitis 5.9 versus 5.8, and upper respiratory tract infection 4.9 versus 4.3.
The EMA classifies the effects of Prolia by frequency. Very common, meaning at least 1 case in 10, are pain in the extremities and musculoskeletal pain. Common, from 1 in 100 to 1 in 10, are constipation, rash, eczema and urinary tract infection. Rare, from 1 in 10,000 to 1 in 1,000, are hypocalcaemia, osteonecrosis of the jaw and atypical femoral fractures.