Diclofenac sodium (ophthalmic)

FDA label, Bausch & Lomb Incorporated, ophthalmic, effective 2026-01-27. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION Cataract Surgery One drop of diclofenac sodium ophthalmic solution should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period. Corneal Refractive Surgery One or two drops of diclofenac sodium ophthalmic solution should be applied to the operative eye within the hour prior to corneal refractive surgery.

Contraindications

Diclofenac sodium ophthalmic solution is contraindicated in patients who are hypersensitive to any component of the medication.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

A

Likelihood score A: Well known cause of clinically apparent liver injury.

Diclofenac is a commonly used nonsteroidal antiinflammatory drug (NSAID) used for the therapy of chronic forms of arthritis and mild-to-moderate acute pain. Therapy with diclofenac in full doses is frequently associated with mild serum aminotransferase elevations and, in rare instances, can lead to serious clinically apparent, acute or chronic liver disease.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Diclofenac (NIDDK, public domain)Chapter updated May 28, 2025

Pregnancy and lactation

Pregnancy

PREGNANCY

Lactation

Nursing Women It is not known whether topical ophthalmic administration of diclofenac sodium ophthalmic solution could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Breastfeeding (LactMed)

Data on excretion of diclofenac into milk are poor, but the drug has a short half-life and little glucuronide metabolite formation. Levels in milk appear to be quite low. Most reviewers consider diclofenac to be acceptable during breastfeeding.- Other agents having more published information may be preferred, especially while nursing a newborn or preterm infant. Maternal use of diclofenac topical gel or eye drops would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Source: LactMed: Diclofenac (NICHD, public domain)Revised Jul 15, 2026

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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