Ertaczo Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity with oral sertaconazole; increased stillbirths and reduction in live birth indices were reported in rats given oral doses of 20 to 40 times the maximum recommended human dose. There are no controlled data in human pregnancy.
US FDA pregnancy 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.
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