Table 2.
Adverse drug reactions, according to the Adverse Reaction Terminology–World Health Organization (WHO–ART).
| System, organ | WHO–ART | Thiesen et al.19 |
Rashed et al.18 |
Silva et al.20 |
Total |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| n 1 | n1/1457* (%) | n 2 | n2/328 (%) | n 3 | n3/110 (%) | n | n/1895 (%) | CI, 95% | ||
| Gastrointestinal disorders | 0600 | 659 | 45.2 | 118 | 36.0 | 2 | 1.8 | 779 | 41.1 | 38.8–43.5 |
| Skin and appendage disorders | 0100 | 274 | 18.8 | 43 | 13.1 | 11 | 10.0 | 328 | 17.3 | 15.5–19.1 |
| Metabolic and nutritional disorders | 0800 | 37 | 2.5 | 30 | 9.1 | 57 | 51.8 | 124 | 6.5 | 5.4–7.7 |
| Cardiovascular disorders | 1000 | 33 | 2.3 | 50 | 15.2 | 16 | 14.5 | 99 | 5.2 | 4.2–6.3 |
| Psychiatric disorders | 0500 | 50 | 3.4 | 15 | 4.6 | 0 | 0.0 | 65 | 3.4 | 2.6–4.3 |
| Respiratory disorders | 1100 | 44 | 3.0 | 10 | 3.0 | 7 | 6.4 | 61 | 3.2 | 2.4–4.1 |
| Immune disorders and infections | 1830 | 51 | 3.5 | 7 | 2.1 | 1 | 0.9 | 59 | 3.1 | 2.3–3.9 |
| Urinary tract disorders | 1300 | 40 | 2.7 | 3 | 0.9 | 3 | 2.7 | 46 | 2.4 | 1.7–3.2 |
| Blood disorders | 1200 | 13 | 0.9 | 15 | 4.6 | 4 | 3.6 | 32 | 1.7 | 1.1–2.3 |
| Liver and biliary disorders | 0700 | 18 | 1.2 | 8 | 2.4 | 4 | 3.6 | 30 | 1.6 | 1.0–2.2 |
| Neurological disorders | 0400 | 15 | 1.0 | 10 | 3.0 | 2 | 1.8 | 27 | 1.4 | 0.9–2.0 |
| Body as a whole, general disorders | 1810 | 10 | 0.7 | 9 | 2.7 | 0 | 0.0 | 19 | 1.0 | 0.5–1.5 |
| Vascular, bleeding and clotting disorders | 1040 | 0 | 0.0 | 6 | 1.8 | 3 | 2.7 | 9 | 0.5 | 0.1–0.8 |
| Vision disorders | 0431 | 0 | 0.0 | 2 | 0.6 | 0 | 0.0 | 2 | 0.1 | 0.0–0.3 |
| Endocrine disorders | 0900 | 0 | 0.0 | 1 | 0.3 | 0 | 0.0 | 1 | 0.1 | 0.0–0.2 |
| Reproductive disorders | 1400 | 0 | 0.0 | 1 | 0.3 | 0 | 0.0 | 1 | 0.1 | 0.0–0.2 |
| Other reactions | – | 213 | 14.6 | 0 | 0.0 | 0 | 0.0 | 213 | 11.2 | 9.7–12.7 |
CI, confidence interval; ‘n’: sum of ‘n1’, ‘n2’ and ‘n3’.
*
The described value, 1457, which represents the sum of all n1 values, does not match the adverse drug reactions total number, definite and probable, described in the study (1446); however, this error occurred in the publication and therefore, the result presented was kept.