Several African countries have begun using amodiaquine-containing combinations as first-line antimalarial treatment, with the result that a substantial number of pregnant women are likely to be exposed to amodiaquine. However, little information is available on amodiaquine safety and efficacy during pregnancy. Between 1948 and 1990 only six published studies reported amodiaquine use in pregnancy. Only one publication mentioned adverse events, without details. Six additional studies on amodiaquine delivered by mass drug administration or medicated salts gave very little information on amodiaquine safety. Therefore, there is an urgent need for studies on amodiaquine safety and tolerability during pregnancy since current data are not sufficient to recommend its use during pregnancy, particularly as intermittent preventive treatment.