Tolcapone Pregnancy and Breastfeeding Warnings

Brand names: Tasmar

Medically reviewed by Drugs.com. Last updated on Jan 1, 2024.

Tolcapone Pregnancy Warnings

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.

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

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

Further information

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