Quick answers
- What is Loteprednol etabonate used for?
- The FDA-approved label (Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, December 11, 2024) says: “Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Loteprednol etabonate?
- The “Adverse Reactions” section of the FDA label (Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, December 11, 2024) begins: “Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex and perforation of the globe where there is thinning of the cornea or sclera.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Loteprednol etabonate have a boxed warning?
- No. None of the 24 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Loteprednol etabonate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Loteprednol etabonate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 5, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Loteprednol etabonate?
- 11 companies list prescription products of Loteprednol etabonate in the FDA NDC Directory, including Bausch & Lomb Incorporated, Amneal Pharmaceuticals NY LLC and Bausch & Lomb Americas Inc.
What Loteprednol etabonate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (suspension/ drops, ophthalmic), Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 24 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 24 FDA labels for this medicine have a boxed warning.
Loteprednol etabonate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex and perforation of the globe where there is thinning of the cornea or sclera.
Read more of this section
Ocular adverse reactions occurring in 5% to 15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% to 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with loteprednol etabonate ophthalmic suspension, the incidence of clinically significant increases in IOP (≥ 10 mm Hg) was 1% (1/133) with loteprednol etabonate ophthalmic suspension and 1% (1/135) with placebo. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
Loteprednol etabonate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
SHAKE VIGOROUSLY BEFORE USING. One drop instilled into the affected eye(s) four times daily.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
Loteprednol etabonate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic effects Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity.
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The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis with 0.5 to 100 mg/kg/day resulted in embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥ 50 mg/kg/day) and teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses and cleft palate and umbilical hernia at ≥ 50 mg/kg/day). Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. Caution should be exercised when loteprednol etabonate ophthalmic suspension is administered to a nursing woman.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
Loteprednol etabonate and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. Caution should be exercised when loteprednol etabonate ophthalmic suspension is administered to a nursing woman.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
When Loteprednol etabonate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Loteprednol etabonate, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Read more of this section
Loteprednol etabonate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
— FDA label: Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Suspension/ drops · Gel · Ointment · Suspension |
|---|---|
| Route | Ophthalmic |
| Prescription products | 25 in the FDA NDC Directory |
| Brand names | Lotemax, Lotemax Sm, Alrex, Eysuvis |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| loteprednol etabonate 0.38% gel | Brand: Lotemax SM | $49.48 per gram |
| loteprednol etabonate 0.5% gel | Generic | $18.83 per gram |
| loteprednol etabonate 0.5% gel | Brand: Lotemax | $49.66 per gram |
| loteprednol etabonate 0.5% ointment | Brand: Lotemax | $99.74 per gram |
| loteprednol etabonate 2 mg/mL suspension/ drops | Generic | $29.19 per mL |
| loteprednol etabonate 2 mg/mL suspension/ drops | Brand: Alrex | $58.01–$58.04 per mL 2 packages, lowest to highest |
| loteprednol etabonate 2.5 mg/mL suspension/ drops | Brand: Eysuvis | $61.51 per mL |
| loteprednol etabonate 5 mg/mL suspension | Generic | $10.44–$18.71 per mL 2 packages, lowest to highest |
| loteprednol etabonate 5 mg/mL suspension/ drops | Generic | $10.44–$18.71 per mL 13 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bausch & Lomb Incorporated6 products
- Amneal Pharmaceuticals NY LLC3 products
- Bausch & Lomb Americas Inc.3 products
- Armas Pharmaceuticals Inc.3 products
- Sentiss Pharmaceuticals LLC3 products
- Padagis US LLC2 products
- NorthStar RxLLC1 product
- Sportpharm LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Alcon Laboratories, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020583 LOTEMAX | Bausch and Lomb | March 9, 1998 | 7, latest December 16, 2013 2013: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2006: Manufacturing (CMC) |
| NDA020803 ALREX | Bausch and Lomb | March 9, 1998 | 6, latest December 16, 2013 2013: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA200738 LOTEMAX | Bausch and Lomb | April 15, 2011 | 1, latest December 8, 2020 2020: Labeling |
| NDA202872 LOTEMAX | Bausch and Lomb Inc | September 28, 2012 | 1, latest July 20, 2018 2018: Efficacy |
| NDA208219 LOTEMAX SM | Bausch and Lomb Inc | February 22, 2019 | — |
| NDA210933 EYSUVIS | Alcon Labs Inc | October 26, 2020 | — |
Generic approvals (9)
- ANDA207609Sentiss · April 17, 2019
- ANDA212080Sentiss · February 10, 2021
- ANDA212450Sun Pharm · February 26, 2021
- ANDA215933Sentiss · April 12, 2023
- ANDA215719Lupin · April 24, 2024
- ANDA215203Padagis Us · July 10, 2024
- ANDA216345Amneal · December 13, 2024
- ANDA215204Padagis Us · January 29, 2025
- ANDA217484Amneal · May 20, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 5, 2023 · Class III · Terminated · D-0924-2023
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical — SUN PHARMACEUTICAL INDUSTRIES INC
-
June 17, 2019 · Class III · Terminated · D-1396-2019
Failed Stability Specifications: Out of specification for viscosity.
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07. — Bausch & Lomb
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 213262, 213263, 311381, 311382, 1099500, 1099503, 1312625, 1312627, 2118537, 2118539 … (+2) |
|---|---|
| SPL set ID of the quoted label | 3c2e7083-6ba1-4131-a23f-462b02e5c036 |
| FDA labels (SPL) | 24 |
| FDA applications | NDA020583, NDA020803, NDA200738, NDA202872, NDA208219, NDA210933, 9 ANDA |
| Active ingredients (FDA) | LOTEPREDNOL ETABONATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- LotemaxBrand page: products, maker and price
- AlrexBrand page: products, maker and price
- EysuvisBrand page: products, maker and price
- Lotemax SMBrand page: products, maker and price
- Bausch & Lomb IncorporatedMaker or distributor
- Amneal Pharmaceuticals NY LLCMaker or distributor
- Bausch & Lomb Americas Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Loteprednol Etabonate, Amneal Pharmaceuticals NY LLC, effective December 11, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →