Table 6.

Adverse events in ≥ 5% of adults or children (safety population) treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria

Adverse event	Adults (n = 647), no. (%)	Children (n = 1,332), no. (%)
Any	557 (86.1)	970 (72.8)
Headache	360 (55.6)	168 (12.6)
Anorexia	260 (40.2)	175 (13.1)
Dizziness	253 (39.1)	56 (4.2)
Asthenia	243 (37.6)	63 (4.7)
Arthralgia	219 (33.8)	39 (2.9)
Myalgia	206 (31.8)	39 (2.9)
Nausea	169 (26.1)	61 (4.6)
Pyrexia	159 (24.6)	381 (28.6)
Chills	147 (22.7)	72 (5.4)
Sleep disorder	144 (22.3)	27 (2.0)
Palpitations	115 (17.8)	24 (1.8)
Vomiting	113 (17.5)	242 (18.2)
Abdominal pain	112 (17.3)	112 (8.4)
Fatigue	111 (17.2)	46 (3.5)
Hepatomegaly	59 (9.1)	75 (5.6)
Splenomegaly	57 (8.8)	124 (9.3)
Diarrhea	46 (7.1)	100 (7.5)
Cough	37 (5.7)	302 (22.7)
Anemia	23 (3.6)	115 (8.6)
P. falciparum infections	13 (2.0)	224 (16.8)