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Amisulpride Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Sep 7, 2022.

Amisulpride is also known as: Barhemsys

Amisulpride Pregnancy Warnings

Animal studies have revealed evidence of reproductive toxicity, including preimplantation loss, slight ossification impairment, and decreased pup weight gain to weaning. Reversible female infertility was observed in animal models when this drug was given prior to mating, but the effect usually normalized a few days after treatment was stopped. There are no controlled data in human pregnancy.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: There are insufficient data available on use of this drug in pregnant women to inform of drug-related risks of birth defects, miscarriage, or adverse maternal/fetal outcomes.

-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Some experts recommend using the lowest possible doses for the shortest possible time if this drug is to be used during pregnancy.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

See references

Amisulpride Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

-Some experts state that use of this drug during lactation is contraindicated.
-In parenteral formulations, some manufacturers state that patients should consider interrupting breastfeeding and breastmilk should be pumped and discarded for 48 hours after administration.
-The effects in the nursing infant are unknown.

Maternal breastmilk levels exceeded 10% of the maternal dose in some patients.

This drug increases serum prolactin, and galactorrhea occurred more frequently in patients given this drug compared to other antipsychotic agents.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Barhemsys (amisulpride)." Acacia Pharma, Inc (2020):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. National Library of Medicine (US) "Drugs and Lactation Database (LactMed)" (2019):
  4. "Product Information. Barhemsys (amisulpride)." Acacia Pharma, Inc (2020):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.