Ketorolac (ophthalmic)

FDA label, Pacific Pharma, Inc., ophthalmic, effective 2024-06-21. Full label on DailyMed

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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

2 DOSAGE AND ADMINISTRATION One drop of ketorolac tromethamine ophthalmic solution should be applied in the operated eye 4 times per day as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery. 2.1 Recommended Dosing The recommended dose of ketorolac tromethamine ophthalmic solution is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery. 2.2 Use With Other Topical Ophthalmic Medications Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other topical ophthalmic medications such as alpha-agonists, antibiotics, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

Contraindications

Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.1) ] . Hypersensitivity to any component of this product. ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

D

Likelihood score D: Possible rare cause of clinically apparent liver injury, perhaps due to bleeding episodes.

Ketorolac is a potent, short acting nonsteroidal antiinflammatory drug (NSAID) that is available in both parenteral and oral forms that is used to treat severe pain but for no more than five days. Ketorolac has been linked to few, poorly understood instances of clinically apparent liver injury in the published literature.

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

Source: LiverTox: Ketorolac (NIDDK, public domain)Chapter updated Aug 5, 2025

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with ketorolac tromethamine ophthalmic solution in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ketorolac tromethamine ophthalmic solution at clinically relevant doses.

Breastfeeding (LactMed)

Milk levels of ketorolac are low with the usual oral dosage, but milk levels have not been measured after higher injectable dosages or with the nasal spray. Ketorolac injection is used for a short time (typically 24 hours) after cesarean section in some hospital protocols with no evidence of harm to breastfed infants. However, the ketorolac dose an infant receives in colostrum is very low because of the small volume of colostrum produced. Some evidence suggests that IV ketorolac as part of a multimodal post-cesarean section analgesia reduces percentage of mothers who fail exclusive breastfeeding compared to patient-controlled IV morphine-based analgesia. Ketorolac has strong antiplatelet activity and can cause gastrointestinal bleeding.

Source: LactMed: Ketorolac (NICHD, public domain)Revised Sep 15, 2025

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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