Clinical Trial Data: Adverse reactions are listed as follows by MedDRA body system organ class and by frequency. The frequency categories based on one year event rates used are: Very common ≥1 in 10; common ≥1 in 100 and <1 in 10; uncommon ≥1 in 1,000 and <1 in 100; rare ≥1 in 10,000 and <1 in 1,000; very rare <1 in 10,000.
Within each frequency grouping and system organ class, undesirable effects are presented in order of decreasing seriousness. (See table.)
Click on icon to see table/diagram/image
Post-Marketing Data: Hypersensitivity Reactions: Hypersensitivity reactions, including rash, urticaria, facial swelling, erythema and anaphylactic reactions have been reported in patients receiving Denosumab (Prolia).
Severe Hypocalcaemia: Severe symptomatic hypocalcaemia has been reported in patients at increased risk of hypocalcaemia receiving Denosumab (Prolia).
Musculoskeletal Pain: Musculoskeletal pain, including severe cases, has been reported in patients receiving Denosumab (Prolia).