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Brimonidine / brinzolamide ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Simbrinza

Medically reviewed by Drugs.com. Last updated on Aug 4, 2025.

Brimonidine / brinzolamide 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: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of maternal toxicity and fetal harm. Animal studies have also shown that this drug crosses the placenta and enters into the fetal circulation to a limited extent. Studies have reported accessory skull bone malformations, unossified sternebrae, reduced ossification of the skull, unossified hyoid, decreased fetal weight and reduced maternal weight gain at doses up to 180 times the recommended human ophthalmic dose. There are no controlled data in human pregnancy.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Brimonidine / brinzolamide ophthalmic Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown (brimonidine, brinzolamide)
Excreted into animal milk: Yes (brimonidine, brinzolamide)

Comments: The effects in the nursing infant are unknown.

See references

Does Brimonidine/brinzolamide ophthalmic interact with my other drugs?

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See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Simbrinza (brimonidine-brinzolamide ophthalmic)." Alcon Laboratories Inc
  4. (2023) "Product Information. Simbrinza (brimonidine-brinzolamide ophthalmic)." Alcon Laboratories Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Simbrinza (brimonidine-brinzolamide ophthalmic)." Alcon Laboratories Inc

Further information

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

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