Animal studies have shown that this drug produced teratogenic effects at maternotoxic doses. There are no adequate and well-controlled studies in pregnant women.

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 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 is not recommended.

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

Comments:
-Signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress, and hypoglycemia) have been observed in the neonate when this drug has been administered until delivery.
-When this drug is administered until delivery, the neonate should be monitored during the first days of life.

See references

Use is not recommended.

Excreted into human milk: Dorzolamide: Unknown; Timolol: Yes
Excreted into animal milk: Dorzolamide: Yes

Comments: The effects in the nursing infant are unknown.

See references