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

Difluprednate ophthalmic Pregnancy and Breastfeeding Warnings

Difluprednate ophthalmic is also known as: Durezol

Medically reviewed on February 15, 2017.

Difluprednate ophthalmic Pregnancy Warnings

Animal studies have shown this drug to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies). There are no adequate and well-controlled studies in pregnant women.

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.

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

US FDA pregnancy category: C

See references

Difluprednate ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

See references

References for pregnancy information

  1. "Product Information. Durezol (difluprednate ophthalmic)." Sirion Therapeutics, Tampa, FL.

References for breastfeeding information

  1. "Product Information. Durezol (difluprednate ophthalmic)." Sirion Therapeutics, Tampa, FL.

Further information

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

Hide