Skip to Content
Get key facts and figures about chronic dry eye

Brimonidine ophthalmic Pregnancy and Breastfeeding Warnings

Brimonidine ophthalmic is also known as: Alphagan, Alphagan P, Lumify, Qoliana

Medically reviewed on April 9, 2018

Brimonidine ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Animal studies have revealed maternotoxicity and increased early
resorptions/post-implantation losses and decreased pup viability and bodyweights at exposures. Additional animal studies have shown that this drug crossed the placenta and entered into the fetal circulation to a limited extent. There are no adequate and well-controlled studies in pregnant women.

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 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

Brimonidine ophthalmic Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Alphagan (brimonidine ophthalmic)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. "Product Information. Alphagan (brimonidine ophthalmic)." Allergan Inc, Irvine, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. 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