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Tolcapone Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jan 2, 2023.

Tolcapone is also known as: Tasmar

Tolcapone Pregnancy Warnings

In rabbits, an increased rate of abortion occurred at 3.7 times the daily recommended human dose. When give to female rats during the last part of gestation and throughout lactation, decreased litter size and impaired growth and learning performance were observed. This drug is generally given with levodopa/carbidopa, and levodopa/carbidopa is known to cause visceral and skeletal malformations in rabbits. The combination of this drug with levodopa/carbidopa in animal studies produced an increased incidence of fetal malformations (primarily external and skeletal digit defects) when compared to levodopa/carbidopa alone. Decreased fetal body weights were also reported. There are no controlled data in human pregnancy.

FDA pregnancy 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

Use is not recommended unless the benefit outweighs the risk to the fetus

US FDA pregnancy category: C

Comments: Women of childbearing potential should be encouraged to use adequate contraception.

See references

Tolcapone Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The risks of severe hepatic injury should be considered.

See references

References for pregnancy information

  1. "Product Information. Tasmar (tolcapone)." Valeant Pharmaceuticals (2001):

References for breastfeeding information

  1. "Product Information. Tasmar (tolcapone)." Valeant Pharmaceuticals (2001):
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):

Further information

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