May 23 2022

Classification of the active ingredient acetylcysteine


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

There are no adequate clinical information on the use of this drug in pregnant women. The few published observations recorded no adverse effects on the mother, fetus or relevant variables regarding pregnancy. In several cases, this was due to treat paracetamol poisoning during labor without detectable consequences related to acetylcysteine??, although the drug crosses the placenta.

No detectable influences of this active substance on laboratory animals treated with intravenous doses up to 7 times higher than recommended in people.

Update 10.12.2010

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.