3. Reported Adverse Drug Reactions (ADRs).
Trial | ADRs: Mother | ADRs: Infant |
Filler 2006 | 1. Less than 1% reported ADRs. 2. In no case was SP withheld because of ADR concerns. 3. No significant difference in proportion of women with ADRs in the 2‐dose and monthly SP arms. 4. No severe ADRs reported | 1. Neonatal jaundice observed in 0.4% of newborns. 2. One neonatal death with jaundice probably due to prematurity |
Hamer 2007 | 1. Rates of ADRs were very low in both groups. 2. Rates did not differ between groups (RR 1.13 for ADRs in the monthly SP group relative to 2‐dose, 95% CI 0.56‐2.18). 3. One mother on monthly SP died from Stevens‐Johnson syndrome | 1. Rates of ADRs very low. 2. Rates similar across the treatment arms (RR 1.49 for ADRs in the monthly group relative to 2‐dose SP, 95% CI 0.79‐2.8) |