Diclofenac ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Voltaren Ophthalmic
Medically reviewed by Drugs.com. Last updated on May 29, 2023.
Diclofenac ophthalmic Pregnancy Warnings
Animal studies have shown reproductive toxicity. 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.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comments:
-Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (premature closure of ductus arteriosus), the use of this drug during late pregnancy should be avoided.
Diclofenac ophthalmic Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Yes
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Product Information. Voltaren (diclofenac). Ciba Vision Ophthalmics. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Voltaren (diclofenac). Ciba Vision Ophthalmics. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
