Table 2.
Classification of frequently reported tramadol-related adverse events from the WebMD and FAERSa data sets.
| WebMD (N=4288) | FAERS (N=123,393) | ||||
| SOCb | Value, n (%) | SOC | Value, n (%) |
|
|
| Number of AEs | 4288 (100.0) | Number of AEs | 123,393 (100.0) |
|
|
| General disorders and administration site conditions | 1360 (31.72) | Psychiatric disorders | 23,340 (18.92) |
|
|
| Psychiatric disorders | 900 (20.99) | General disorders and administration site conditions | 16,899 (13.70) |
|
|
| Nervous system disorders | 827 (19.29) | Injury, poisoning and procedural complications | 15,764 (12.78) |
|
|
| Gastrointestinal disorders | 568 (13.25) | Nervous system disorders | 14,826 (12.02) |
|
|
| Skin and subcutaneous tissue disorders | 239 (5.57) | Gastrointestinal disorders | 9315 (7.55) |
|
|
| Investigations | 80 (1.87) | Respiratory, thoracic and mediastinal disorders | 4839 (3.92) |
|
|
| Musculoskeletal and connective tissue disorders | 64 (1.49) | Musculoskeletal and connective tissue disorders | 4729 (3.83) |
|
|
| Respiratory, thoracic, and mediastinal disorders | 48 (1.12) | Investigations | 4068 (3.30) |
|
|
| Metabolism and nutrition disorders | 40 (0.93) | Skin and subcutaneous tissue disorders | 3665 (2.97) |
|
|
| Eye disorders | 32 (0.75) | Cardiac disorders | 3274 (2.65) |
|
|
| Others | 130 (3.03) | Others | 22,674 (18.38) |
|
|
aFAERS: US Food and Drug Administration (FDA) Adverse Event Reporting System.
bSOC: system organ classes of the Medical Dictionary for Regulatory Activities.