May 19 2022

Classification of the active ingredient Risedronate

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

There are no systematic studies on the use of risedronate during pregnancy, so no data are available about the risk of this substance to the human fetus. It is theoretically possible the appearance of skeletal lesions after following treatment with the drug, although is unknown the circumstances that trigger or promote these injuries.

Studies in experimental animals show decreased survival and birth weight at doses 5 to 25 times greater, respectively, than usual in humans. Also increased ossification defects.

The use of risedronate during pregnancy only is justified if the potential benefits exceeded the possible risks involved.

Update 18.07.2009

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.