Risk level in pregnancy: This medicine is classified as Category B.
Exposure of laboratory animals at doses 13 times those used in humans does not appear to alter the fertility of these, neither seems to have caused fetal harm. However, there are no adequate studies in humans and it is risky to extrapolate data from animal experimentation to the medical clinic, so the use of rabeprazole should be limited to situations where it is clearly essential.
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.