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Timolol Pregnancy and Breastfeeding Warnings

Brand names: Blocadren

Medically reviewed by Drugs.com. Last updated on Jan 14, 2025.

Timolol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

This drug was not shown to be teratogenic in animals at doses approximately 40 times the maximum recommended daily human dose. Doses approximately 830 times the maximum recommended daily human dose were maternotoxic in animals and resulted in an increased number of fetal resorptions. There are no controlled data in human pregnancy.

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

Timolol Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Because of the variability in excretion of this drug into breastmilk and minimal reported experience during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

See references

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2016) "Product Information. Timolol Maleate (timolol)." Mylan Pharmaceuticals Inc
  4. (2024) "Product Information. Timolol Maleate (timolol)." Rising Pharma Holdings Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  4. (2016) "Product Information. Timolol Maleate (timolol)." Mylan Pharmaceuticals Inc

Further information

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