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Dimethyl fumarate Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Nov 15, 2022.

Dimethyl fumarate is also known as: Tecfidera

Dimethyl fumarate Pregnancy Warnings

Animal studies have shown reproductive toxicity. There are no or limited data on the use of DMF in humans. Dimethyl fumarate is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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.

Use DMF only if clearly needed and benefit outweighs risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

See references

Dimethyl fumarate Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue dimethyl fumarate (DMF), taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

See references

See also

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. Tecfidera (dimethyl fumarate)." Biogen (2013):

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. "Product Information. Tecfidera (dimethyl fumarate)." Biogen (2013):

Further information

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

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