May 19 2022

Classification of the active ingredient albendazole


Risk level in pregnancy: This medicine is classified as Category C.

Active substance albendazole has shown to be teratogenic in laboratory animals, causing embryotoxicity and skeletal malformations in pregnant rats and rabbits.

Malformations in rodents presented with oral doses of 10 and 30 mg/ kg/day, equivalent to tenth to one third of the equivalent dose in humans.

There are no adequate and well controlled studies on albendazole administraci??n in pregnant women. The drug must be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Update 03.06.10

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.