Table 7.
Causality assessment and severity assessment of adverse drug reactions
| ADR (n=236) | Naranjo Scale[7] | Modified Hartwig and Siegel Scale[8] | ||||
|---|---|---|---|---|---|---|
| Definite | Probable | Possible | Mild | Moderate | Severe | |
| Acne vulgaris | 8 | 3 | 2 | 0 | 13 | 0 |
| Arthralgia | 0 | 18 | 15 | 7 | 23 | 3 |
| Dermatitis | 3 | 4 | 0 | 0 | 7 | 0 |
| Giddiness | 0 | 9 | 12 | 3 | 16 | 2 |
| Gynecomastia | 3 | 0 | 0 | 0 | 3 | 0 |
| Hypothyroidism | 7 | 0 | 0 | 0 | 7 | 0 |
| Nausea and vomiting | 0 | 27 | 56 | 38 | 36 | 9 |
| Nephrotoxicity | 0 | 0 | 3 | 0 | 0 | 3 |
| Ototoxicity | 3 | 3 | 0 | 3 | 2 | 1 |
| Peripheral neuropathy | 0 | 8 | 13 | 3 | 13 | 5 |
| Psychosis | 4 | 0 | 0 | 0 | 0 | 4 |
| Severe gastritis | 0 | 5 | 14 | 6 | 10 | 3 |
| Tinnitus and mild hearing loss | 1 | 5 | 10 | 2 | 12 | 2 |
| Total, n (%) | 29 (12.28) | 82 (34.74) | 125 (52.96) | 62 (26.27) | 142 (60.16) | 32 (13.55) |
ADRs: Adverse drug reaction