May 19 2022

Classification of the active ingredient imiquimod

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

There are no studies to support the use of imiquimod during pregnancy, so that, if necessary, the clinician should weigh the potential benefits against the risks inherent to the use of the drug.

Studies in pregnant laboratory animals treated with oral doses of 1-20 mg / kg of imiquimod showed a higher incidence of fetal resorption, decreased fetal weight and delayed ossification, and other anomalies more infrequent. In contrast, IV doses of 0.5-2 mg / kg showed no effect on the embryo or fetus.

Update 17.12.2010

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.