Skip to Content

Linagliptin / metformin Pregnancy and Breastfeeding Warnings

Linagliptin / metformin is also known as: Jentadueto, Jentadueto XR

Medically reviewed on Apr 13, 2018

Linagliptin / metformin Pregnancy Warnings

AU and UK: Use should be avoided.
US: This drug should only be used if clearly needed.

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

Animal studies with linagliptin and metformin have failed to reveal evidence of teratogenicity or effects on prenatal or postnatal development. There are no adequate and well controlled studies in pregnant women with the combination linagliptin/metformin or with the individual components.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Linagliptin / metformin Breastfeeding Warnings

Use should be avoided: A decision should be made to discontinue breastfeeding or discontinue drug, taking into account the importance of the drug to the mother and breastfeeding to the child.

Excreted into human milk: Unknown (linagliptin); Yes (metformin)
Excreted into animal milk: Yes (linagliptin); Yes (metformin)

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Jentadueto (linagliptin-metformin)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Jentadueto (linagliptin-metformin)." Boehringer Ingelheim, Ridgefield, CT.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

Hide