Prescription medicine

Loteprednol Brand names: Lotemax, Alrex, Eysuvis

Loteprednol (Lotemax) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $10.47 per mL (Loteprednol etabonate 0.5% drp) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the loteprednol FDA label on DailyMed (effective February 7, 2026, Bausch & Lomb Americas Inc.); the NDA 20841 record on Drugs@FDA; every loteprednol label on DailyMed.

Highlights of the record

FDA label of February 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Loteprednol Etabonate Ophthalmic Suspension, 0.2% is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Forms and strengths

2 mg/ml
2.5 mg/ml
3.8 mg/g
5 mg/ml
5 mg/g

Suspension/ drops; gel; ointment; suspension.

On the market

Earliest approval on file: March 9, 1998 Lotemax, Pharmos; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 13 first April 17, 2019; 11 with a marketed status in Drugs@FDA
Labelers listed (NDC): 11 of which 8 under generic applications, 2 under brand applications, repackagers included
Last listed patent: December 23, 2036 Lotemax Sm gel; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $10.47 per mL Loteprednol etabonate 0.5% drp
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2019 0 Class I among all firms' recalls; latest July 5, 2023
FAERS reports: 5,309 through July 30, 2026

What is loteprednol used for?

From the label: indications and usage
Loteprednol Etabonate Ophthalmic Suspension, 0.2% is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Conditions named in the indications of loteprednol's FDA labels, with every medicine labeled for each:

Pain

From other loteprednol labels
Pain: Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

FDA pharmacologic class: Corticosteroid.

Source: FDA drug label (loteprednol etabonate), Bausch & Lomb Americas Inc., effective February 7, 2026 (SPL set 7714824b-29ed-442a-ad2d-13ee2fc6bc42), via openFDA; the full label on DailyMed

Is there a generic for loteprednol (Lotemax)?

The FDA approved the first generic loteprednol on April 17, 2019. 13 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists loteprednol from 8 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Lotemax gel; a patent listed only for Lotemax Sm gel runs to December 23, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1998 earliest approval on file
2019 first generic approved
2036 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for loteprednol (Lotemax)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.47 per mL (Loteprednol etabonate 0.5% drp), down 46% from $19.52 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Loteprednol etabonate 0.5% drp (generic)
Alrex 0.2% eye drops (brand)

$58.23

$10.47

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Loteprednol 0.5% ophthalmc gel	Generic	$18.19 per gram	n/a	+23%
Loteprednol etabonate 0.2% drp	Generic	$30.72 per mL	n/a	-14%
Loteprednol etabonate 0.5% drp	Generic	$10.47 per mL	n/a	-46%
Alrex 0.2% eye drops	Brand	$58.03 per mL	n/a	no change
Eysuvis 0.25% eye drops	Brand	$61.51 per mL	n/a	+3%
Lotemax 0.5% eye ointment	Brand	$99.74 per gram	n/a	+0.1%
Lotemax 0.5% ophthalmic gel	Brand	$49.66 per gram	n/a	-0.1%
Lotemax sm 0.38% eye gel	Brand	$49.48 per gram	n/a	-0.1%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has loteprednol been recalled?

The FDA's Enforcement Report lists 2 recalls naming loteprednol since 2019: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
July 5, 2023	Class III	SUN PHARMACEUTICAL INDUSTRIES INC	Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
June 17, 2019	Class III	Bausch & Lomb	Failed Stability Specifications: Out of specification for viscosity.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the loteprednol label say about other medicines?

The loteprednol label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Fluorescein	warnings and precautions	… examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. ( 5.1 ) Intraocular Pressure (IOP) Increase:

Check loteprednol against other medicines

Source: FDA drug label (loteprednol etabonate), Bausch & Lomb Americas Inc., effective February 7, 2026 (SPL set 7714824b-29ed-442a-ad2d-13ee2fc6bc42), via openFDA; the full label on DailyMed

What do FAERS reports show for loteprednol?

The FDA Adverse Event Reporting System holds 5,309 reports that list loteprednol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 134 are coded as a death and 625 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Eye Pain701
Eye Irritation602
Off Label Use (a use or a product term, not a reaction)438
Drug Ineffective (a use or a product term, not a reaction)421
Vision Blurred397
Ocular Hyperaemia337
Headache (named in the label)276
Fatigue251

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as loteprednol?

6 other medicines are given the same way (ophthalmic) and in the same FDA class as loteprednol or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (ophthalmic)	Pharmacy cost	Shortage
Clobetasol	Pain	none listed	n/a	No current entry
Dexamethasone	Pain	1 labeler	$8.17 per mL 0.1% eye drop	In shortage
Ketorolac	Pain	17 labelers	$1.39 per mL 0.5% eye solution	In shortage
Bromfenac	Pain	9 labelers	$13.25 per mL 0.07% eye drp	No current entry
Diclofenac	Pain	5 labelers	$1.70 per mL 0.1% eye drops	A presentation being discontinued
Nepafenac	Pain	none listed	$121.14 per mL 0.3% eye drops	No current entry

Every medicine labeled for the same conditions as loteprednol

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to loteprednol: 6 medicines for the same use
Other corticosteroids: the pharmacologic class, with prices and generics
Loteprednol side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other