Table 2.
Characteristics of the adverse drug reaction reports on the four most common MedDRA organ system class of tapentadol and oxycodone/naloxone.
| Nervous system disorders | Psychiatric disorders | General disorders and administration site conditions | Gastrointestinal disorders | |
|---|---|---|---|---|
| Tapentadol | n = 52 (50%) (69 reaction terms)* | n = 34 (32.7%) (38 reaction terms)* | n = 21 (20.2%) (24 reaction terms)* | n = 18 (17.3%) (24 reaction terms)* |
| Serotonin toxicity, n = 16 (23.2)**
Dizziness, n = 6 (8.7) Tremor, n = 6 (8.7) Other, n = 41 (59.4) |
Delirium, n = 7 (18.4) Hallucination, n = 5 (13.1) Confusional state, n = 5 (13.1) Other, n = 21 (68.4) |
Malaise, n = 5 (20.8) Drug ineffective, n = 4 (16.6) Other, n = 15 (41.6) |
Nausea, n = 10 (41.6) Abdominal pain upper, n = 2 (8.3) Vomiting, n = 2 (8.3) Other, n = 10 (41.6) |
|
| Age, mean | 51.4 | 51.7 | 46.3 | 43.3 |
| Missing age | 22 | 11 | 7 | 5 |
| Female sex, n | 36 | 19 | 13 | 12 |
| Missing sex | 2 | 2 | 2 | 2 |
| Causality possible, n | 52 | 34 | 21 | 18 |
| Outcome, n | ||||
| Recovered | 25 | 22 | 15 | 10 |
| Not yet recovered | 2 | 0 | 0 | 0 |
| Death | 1 | 0 | 0 | 1 |
| Outcome missing | 24 | 12 | 6 | 7 |
| Oxycodone/Naloxone | n = 62 (24.9%) (84 reaction terms)* | n = 78 (31.3%) (129 reaction terms)* | n = 87 (35%) (108 reaction terms)* | n = 73 (29.3%) (116 reaction terms)* |
| Dizziness, n = 9 (10.7) Somnolence, n = 8 (9.5) Tremor, n = 8 (9.5) Other, n = 59 (70.2) |
Hallucinations, n = 22 (17) Delirium, n = 12 (9.3) Withdrawal syndrome, n = 12 (9.3) Other, n = 83 (64.3) |
Drug withdrawal syndrome, n = 28 (26) Drug ineffective, n = 9 (8.3) Other, n = 71 (65.8) |
Nausea, n = 24 (20.7) Diarrhoea, n = 23 (19.9) Other, n = 69 (59.5) |
|
| Age, mean | 64.1 | 64.4 | 58.4 | 61.0 |
| Missing age | 7 | 18 | 24 | 19 |
| Female sex, n | 41 | 42 | 56 | 51 |
| Missing sex | 0 | 1 | 0 | 1 |
| Causality possible, n | 62 | 78 | 87 | 73 |
| Outcome, n | ||||
| Recovered | 32 | 45 | 48 | 42 |
| Not yet recovered | 6 | 10 | 8 | 11 |
| Recovering | 2 | 4 | 4 | 0 |
| Death | 2 | 1 | 2 | 1 |
| Unrelated death | 0 | 0 | 1 | 1 |
| Outcome missing | 20 | 18 | 24 | 18 |
*
Serotonin toxicity, n = 14 involved the use of one or more serotonergic agents (e.g. tramadol, duloxetine, venlafaxine, amitriptyline, sertraline, desvenlafaxine, escitalopram).
**
More than 1 reaction term can appear per report.
MedDRA, Medical Dictionary for Regulatory Activities.