Risk level in pregnancy: This medicine is classified as Category B.
There are no adequate and well controlled studies on the use of eplerenone in pregnant women. Manufacturer recommends using this drug only if the potential benefit outweighs the potential risk to the fetus.
Although animal testing are not directly transferable to humans, studies on embryonic and fetal development in rats and rabbits at exposures over 30 times the human therapeutic dose showed no teratogenic effects, but, it was observed a decrease in the weight of the rabbits, increased fetal resorptive phenomena and postimplantation loss with higher doses.
Meaning of category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.