May 19 2022

Classification of the active ingredient aceclofenac

Risk level in pregnancy: This medicine is classified as Category category C for the first two quarters and D during the third quarter.

There are no controlled studies about the influence of aceclofenac in pregnancy, so its use should be avoided unless the benefit to the mother clearly outweighs the risk to the fetus.

Treatment with anti-inflammatory drugs (NSAIDs) during pregnancy may give rise to a rare form of fetal anomalies, which do not correspond to a particular type teratogen.

As is known, NSAIDs can cause fetal cardiovascular changes, including the closure of the ductus arteriosus and persistent pulmonary hypertension in the newborn, so that the use of these drugs is formally contraindicated during the third trimester of pregnancy. Moreover, NSAIDs regularly used for this stage of gestation may decrease the uterine contractility and tone. Because of this, it may take labor and increase its duration, which increases the risk of bleeding, both the mother and the newborn.

Studies in experimental animals indicate no evidence of teratogenicity in rats, while in rabbits, at doses of 10 mg/ kg/day were found in some fetuses morphological abnormalities.

Update 21.08.2009

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.