Risk level in pregnancy: This medicine is classified as Category C.
There are no controlled studies to establish the efficacy and safety of amisulpride use during pregnancy, so the drug should be used only if the potential benefit outweighs the risk to the fetus.
The limited data available do not reveal teratogenic effects to the fetus from the use of this drug, although amisulpride can, from a theoretical point of view, cause some disorders resulting from atropinic effect, when administered at the end of the pregnancy, especially if the doses are high or taken with substances with antiparkinsonian effect:
Tachycardia, hyperstimulation, abdominal distention, delayed passage of meconium, extrapyramidal signs (hypertonia, tremor) and sedation.
If amisulpride is used during pregnancy, infants should be provided with adequate control, monitoring symptoms mainly referred above.
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.