Lidocaine (ophthalmic)

FDA label, Thea Pharma Inc., ophthalmic, effective 2026-04-23. Full label on DailyMed

Patient handout

Looking up MedlinePlus…

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.

Contraindications

None. None. ( 4 )

Safety data

Reported adverse events (FAERS)

Loading
Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for lidocaine (ophthalmic). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with AKTEN in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous administration of lidocaine to pregnant rats at doses >800-fold the human dose based on body surface area did not result in adverse developmental effects. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Breastfeeding (LactMed)

Lidocaine concentrations in milk during continuous IV infusion, epidural administration and in high doses as a local anesthetic are low and the lidocaine is poorly absorbed by the infant. Lidocaine is not expected to cause any adverse effects in breastfed infants. No special precautions are required.- Lidocaine during labor and delivery with other anesthetics and analgesics has been reported by some to interfere with breastfeeding. However, this assessment is controversial and complex because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient design of many of the studies.

Alternatives LactMed suggests considering:
Source: LactMed: Lidocaine (NICHD, public domain)Revised Dec 15, 2024

Supply and cost

Drug shortage status

Loading

Recalls (last 24 months)

Loading

Therapeutic equivalence (Orange Book)

Loading

Price ladder

Not the price at the counter
Loading

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

Loading

Recruiting clinical trials

Loading