Adverse events. Data are number of events (rate per patient-year).
| Febuxostat 80 mg, N = 801 PY = 1480 | Febuxostat 120 mg, N = 487 PY = 803 | Allopurinol, N = 178 PY = 173 | |
|---|---|---|---|
| Most frequently reported* adverse events** | |||
| Total number of adverse events | 3362 (227) | 1736 (216) | 423 (245) |
| Upper respiratory tract infections | 375 (25) | 181 (23) | 38 (22) |
| Musculoskeletal and connective tissue signs and symptoms | 197 (13) | 116 (14) | 31 (18) |
| Joint-related signs and symptoms | 134 (9) | 72 (9) | 14 (8) |
| Skin injuries | 31 (2) | 11 (1) | 9 (5) |
| Headaches | 58 (4) | 64 (8) | 10 (6) |
| Lower respiratory tract and lung infections | 81 (5) | 31 (4) | 7 (4) |
| Vascular hypertensive disorders | 81 (5) | 31 (4) | 7 (4) |
| Gastrointestinal atonic and hypomotility disorders | 25 (2) | 23 (2) | 9 (5) |
| Diarrhea | 40 (3) | 37 (5) | 4 (2) |
| All serious adverse events† | |||
| Total number of serious adverse events | 165 (11) | 73 (9) | 21 (12) |
| Cardiac disorders | 46 (3) | 17 (2) | 5 (3) |
| Musculoskeletal and connective tissue disorders | 8 (< 1) | 11 (1) | 2 (1) |
| Infections and infestations | 28 (2) | 7 (< 1) | 3 (2) |
| Nervous system disorders | 12 (< 1) | 6 (< 1) | 2 (1) |
| Gastrointestinal disorders | 5 (< 1) | 8 (< 1) | 2 (1) |
| Hepatobiliary disorders | 10 (< 1) | 1 (< 1) | 3 (2) |
| Vascular disorders | 10 (< 1) | 4 (< 1) | 2 (1) |
| Metabolism and nutrition disorders | 2 (< 1) | 2 (< 1) | 0 |
| Renal and urinary disorders | 4 (< 1) | 2 (< 1) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 10 (< 1) | 2 (< 1) | 1 (< 1) |
| Injury, poisoning, and procedural complications | 13 (< 1) | 1 (< 1) | 0 |
| Neoplasms benign, malignant, and unspecified | 11 (< 1) | 5 (< 1) | 0 |
| Ear and labyrinth disorders | 0 | 4 (< 1) | 0 |
| Blood and lymphatic system disorders | 2 (< 1) | 0 | 0 |
| General disorders and administration site conditions | 2 (< 1) | 2 (< 1) | 0 |
| Skin and subcutaneous tissue disorders | 1 (< 1) | 0 | 1 (< 1) |
| Congenital, familial, and genetic disorders | 0 | 1 (< 1) | 0 |
| Investigations | 1 (< 1) | 0 | 0 |
| Deaths | 7 (< 1) | 3 (< 1) | 0 |