Table 3.
Risk of ADRs related to off-label drug use
| Off-label status | Patients n = 1419 | Percentage(95% CI) | RR*(95% CI) |
|---|---|---|---|
| Total of off label | 601 | 42.35 (39.78, 44.92) | 3.44 (1.26, 9.38) |
| Contraindication | 24 | 1.69 (1.01, 2.45) | 5.38 (0.62, 46.57) |
| Different indication | 391 | 27.55 (25.23, 29.87) | 4.42 (1.60, 12.25) |
| Higher dose | 89 | 6.27 (4.97, 7.65) | 1.65 (0.36, 7.57) |
| Lower dose | 105 | 7.40 (5.98, 8.89) | 1.12 (0.19, 6.55) |
| Age | 45 | 3.17 (2.24, 4.18) | 1.71 (0.21, 13.80) |
| Route of administration | 18 | 1.27 (0.68, 1.94) | 3.71 (0.42, 32.48) |
| Inadvisable coprescription | 29 | 2.04 (1.30, 2.87) | No ADR |
ADRs, adverse drug reactions; RR, relative risk; CI, confidence interval.
*
Adjusted according to classes of age, gender, ATC classes and number of prescription.