Skip to Content

Diclofenac ophthalmic Pregnancy and Breastfeeding Warnings

Diclofenac ophthalmic is also known as: Voltaren Ophthalmic

Diclofenac ophthalmic Pregnancy Warnings

Diclofenac ophthalmic has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of dystocia, prolonged gestation, reduced fetal weights, growth, and survival associated with maternally toxic levels of orally administered diclofenac. Ocularly applied diclofenac undergoes minimal systemic absorption. There are no controlled data in human pregnancy. Diclofenac ophthalmic is only recommended for use during pregnancy when benefit outweighs risk. The manufacturer recommends that the use of diclofenac ophthalmic be avoided during late pregnancy because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (premature closure of the ductus arteriosus).

See references

Diclofenac ophthalmic Breastfeeding Warnings

While the manufacturer recommends avoiding diclofenac during lactation, one review paper recommends diclofenac as a suitable nonsteroidal anti-inflammatory agent for use during lactation. The authors based this recommendation on the short half-life and results of a study which failed to detect diclofenac in human milk (less than 10 ng/mL) following either a single 50 mg oral dose or a daily oral dose of 100 mg for 1 week.

There are no data on the excretion of diclofenac ophthalmic into human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Voltaren (diclofenac)." Ciba Vision Ophthalmics, Duluth, GA.

References for breastfeeding information

  1. "Product Information. Voltaren (diclofenac)." Ciba Vision Ophthalmics, Duluth, GA.
  2. Needs CJ, Brooks PM "Antirheumatic medication during lactation." Br J Rheumatol 24 (1985): 291-7

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.