Erythromycin (ophthalmic)

FDA label, Bausch & Lomb Incorporated, ophthalmic, effective 2026-08-28. 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.

Macrolide Antimicrobial, Macrolide

Dosing in kidney impairment

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

Contraindications

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

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.

Erythromycin is an oral macrolide antibiotic that has been in common use since the 1950s. Erythromycin has been linked to rare instances of acute liver injury that are usually self-limited, but can result in severe injury and death.

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

Source: LiverTox: Erythromycin (NIDDK, public domain)Chapter updated Aug 10, 2017

Pregnancy and lactation

Pregnancy

Pregnancy: Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Lactation

Nursing Mothers: Caution should be exercised when erythromycin is administered to a nursing woman.

Breastfeeding (LactMed)

Because of the low levels of erythromycin in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant. Monitor the infant for irritability and possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). One case report and unconfirmed epidemiologic evidence indicates that hypertrophic pyloric stenosis in infants might occur with maternal use of erythromycin during the first two weeks of breastfeeding; however, if it occurs, the frequency is very low and others have questioned this relationship. Infant side effects are unlikely with topical application for acne, although topical application to the nipple may increase the risk of diarrhea in the infant.

Source: LactMed: Erythromycin (NICHD, public domain)Revised Nov 15, 2024

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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Price ladder

Not the price at the counter
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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

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Recruiting clinical trials

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