Tetrabenazine Pregnancy and Breastfeeding Warnings

Brand names: Xenazine

Tetrabenazine Pregnancy Warnings

Use is not recommended unless no other treatment is available and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: This drug crosses the placenta.

Animal studies have revealed increased stillbirths, hypothermia, mortality, and delayed development. Data from animals also showed disrupted estrous cyclicity in females, but no effects on mating and fertility indices or sperm parameters in males. There are no controlled data in human pregnancy; the potential risk to humans is unknown.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US 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

Tetrabenazine Breastfeeding Warnings

AU and UK: Use is contraindicated.
US: A decision should be made to discontinue the drug or to discontinue breastfeeding, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

Further information

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

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