Table 4. The incidence of adverse drug reactions caused by prophylactic INH.
Number of cases a | Incidence rate (95% CI) b | |
---|---|---|
Mild-to-moderate adverse drug reactions | 85 | 110.4 (88.2 to 136.5) |
AST/ALT elevation | 31 | 40.3 (27.4 to 57.2) |
Peripheral neuropathy | 26 | 33.8 (22.1 to 49.5) |
GI discomfort | 10 | 13.0 (6.2 to 23.9) |
Skin rash | 6 | 7.8 (2.9 to 17.0) |
Thrombocytopenia | 5 | 6.5 (2.1 to 15.2) |
Anemia | 1 | 1.3 (0.03 to 7.2) |
Leukopenia | 1 | 1.3 (0.03 to 7.2) |
Anorexia | 2 | 2.6 (0.3 to 9.4) |
Others c | 3 | 3.9 (0.8 to 11.4) |
Severe adverse drug reactions d | 1 | 1.3 (0.03 to 7.2) |
Fulminant hepatitis | 1 | 1.3 (0.03 to 7.2) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; GI, gastrointestinal; INH, isoniazid; NA, not applicable.
a The total observation period was 77.0 person-years for 152 episodes.
b Rate per 100 person-years.
c Including eosinophilia (n = 1), pruritus (n = 1), and general weakness (n = 1).
d Occurred in the high-risk subgroup.