FDA-filed SPL labeling · retrieved through openFDA

Latanoprostene Bunod Ophthalmic

Latanoprostene bunod ophthalmic solution is a prostaglandin analog eye drop used to lower elevated eye pressure in adults with open-angle glaucoma or ocular hypertension.

Brand name Vyzulta
Rx Form 1 Route Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 27, 2024
AvailabilityRx
Earliest approval/marketing year 2017
FDA-listed product records 2
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 15, 2026
Latanoprostene Bunod Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Vyzulta (latanoprostene bunod) is a once-nightly eye drop that lowers intraocular pressure in people with open-angle glaucoma or ocular hypertension. It works well when used consistently each evening, but it can permanently change your eye color, so regular eye exams are important. Talk to your doctor before using it if you are pregnant, have active eye inflammation, or are considering it for a child under 16.

📖 Latanoprostene Bunod Ophthalmic: Patient Information Guide

A plain-language walkthrough of Latanoprostene Bunod Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Latanoprostene bunod ophthalmic solution is approved to lower intraocular pressure (pressure inside the eye) in adults. Specifically:

  • Vyzulta 0.024% eye drops are indicated for reducing intraocular pressure in adults with open-angle glaucoma
  • Vyzulta 0.024% eye drops are indicated for reducing intraocular pressure in adults with ocular hypertension (elevated eye pressure without glaucoma damage)
⚙️How it works

After you apply the drop, latanoprostene bunod is rapidly converted inside the eye into two active compounds: latanoprost acid, a prostaglandin analog, and butanediol mononitrate, which releases nitric oxide. Latanoprost acid promotes drainage of aqueous humor (the fluid inside the eye) through both the trabecular meshwork and the uveoscleral pathway. Nitric oxide helps relax the trabecular meshwork tissue, making it easier for fluid to flow out. Less fluid buildup means lower pressure inside the eye, which reduces the risk of glaucoma progression and vision loss.

💊How it's taken

Vyzulta is applied as one drop into the affected eye or eyes once each evening. Using it more than once a day can actually weaken its pressure-lowering effect, so stick to the evening routine.

  • If you use other eye drops for eye pressure, separate each one by at least 5 minutes
  • Remove contact lenses before applying; wait 15 minutes before reinserting them
  • Follow your prescriber's specific instructions — do not adjust your own dose or timing
🤒Side effects — in detail

The most common side effects with Vyzulta are eye-related and generally mild:

  • Red or pink eyes (conjunctival hyperemia) — seen in about 6% of people
  • Eye irritation — about 4%
  • Eye pain — about 3%
  • Stinging at the time of application (instillation site pain) — about 2%
  • Gradual darkening of the iris (eye color change) — may be permanent
  • Eyelash changes: longer, thicker, or more lashes — usually reversible after stopping

Contact your doctor right away if you develop worsening eye redness, pain, blurred vision, or signs of infection — these can signal a more serious problem like eye inflammation, macular edema, or bacterial keratitis.

⚠️Warnings & precautions
  • Permanent iris darkening: Vyzulta can slowly increase brown pigment in the iris. This is likely permanent even after you stop the medication. Regular eye exams help track any changes.
  • Eyelid and eyelash changes: Skin around the eye may darken, and lashes may grow longer or thicker. These changes are usually reversible when treatment stops.
  • Eye inflammation: Use with caution if you have a history of iritis or uveitis; avoid if inflammation is currently active, as Vyzulta may make it worse.
  • Macular edema: Swelling in the central retina has been reported with prostaglandin analogs. Extra caution is needed if you've had certain types of cataract surgery or have other risk factors.
  • Bacterial keratitis (eye infection): Do not touch the dropper tip to your eye or any surface — contamination of the bottle has been linked to serious eye infections, especially when the eye surface is compromised.
  • Contact lenses: Always remove lenses before applying Vyzulta; the preservative (benzalkonium chloride) can be absorbed by lenses. Wait 15 minutes before putting lenses back in.
🔀What it interacts with

There are limited systemic drug interactions because Vyzulta is applied directly to the eye, but there are two important practical considerations:

  • Other eye pressure-lowering drops: Space them at least 5 minutes apart from Vyzulta — mixing drops too close together can reduce effectiveness
  • Contact lenses: Benzalkonium chloride, the preservative in Vyzulta, is absorbed by soft contact lenses and could irritate the eye — always remove lenses first and wait 15 minutes after dosing

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Eye inflammation (iritis/uveitis): Tell your doctor if you have a history of this — Vyzulta needs extra caution and should generally not be used during active flare-ups
  • Macular edema risk: Alert your doctor if you have had cataract surgery (especially with a torn posterior lens capsule) or other known risk factors for retinal swelling
  • Pregnancy: Animal studies showed serious fetal harm at relatively low doses. There are no human data. Tell your doctor if you are pregnant or trying to conceive before using Vyzulta.
  • Breastfeeding: It is unknown whether Vyzulta passes into breast milk. Discuss risks and benefits with your doctor.
  • Children 16 and younger: Vyzulta is not recommended for pediatric patients due to concerns about long-term pigmentation effects from chronic use.
  • Older adults (65+): No dose adjustment is needed — safety and effectiveness are similar to younger adults.
📡Pharmacodynamics — effects in the body

After the first dose of Vyzulta, intraocular pressure starts to fall within about 1 to 3 hours. The maximum pressure-lowering effect is reached roughly 11 to 13 hours after administration in eyes with elevated pressure. This is why the drop is taken in the evening — the peak effect lines up with the overnight hours when eye pressure can tend to rise.

🔬Pharmacokinetics — how your body processes it

When applied to the eye, latanoprostene bunod is rapidly broken down into its active components: latanoprost acid and butanediol mononitrate. Latanoprost acid reaches peak levels in the bloodstream in about 5 minutes after dosing, but blood concentrations are very low and clear quickly — falling below detectable limits in most people within 15 minutes. Latanoprost acid is then processed primarily by the liver. Butanediol mononitrate breaks down into nitric oxide and other byproducts that enter normal metabolic pathways. The overall systemic exposure is minimal with once-daily eye drop use.

📦How to store it

Unopened bottle should be stored refrigerated at 2°C to 8°C (36°F to 46°F). stored at 2°C to 25°C (36°F to 77°F) for 8 weeks. Protect from light.

📄 Written from Latanoprostene Bunod Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Latanoprostene Bunod Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Vyzulta used for?
Vyzulta is an eye drop used to lower the pressure inside your eye. It's prescribed for people with open-angle glaucoma or ocular hypertension — a condition where eye pressure is higher than normal. Keeping that pressure under control helps protect your vision and slows glaucoma from getting worse.
Why does it need to be used in the evening? Can I use it in the morning instead?
The evening timing is intentional — the pressure-lowering effect peaks about 11 to 13 hours after you use the drop, which lines up with the overnight period. More importantly, you should only use it once a day and not switch to the morning without talking to your doctor. Using it more than once a day can actually make it less effective.
Will Vyzulta change the color of my eyes permanently?
Possibly, yes — and this is one of the most important things to know about this medication. Vyzulta can slowly increase brown pigment in the iris (the colored part of your eye), and this change is likely permanent even if you stop the medication later. It can take months to years to notice. The skin around your eyelid may also darken, but that change is usually reversible. Your eye doctor will keep an eye on this at your regular visits.
Can I use Vyzulta with my contact lenses in?
No — remove your contact lenses before putting the drop in. Vyzulta contains a preservative called benzalkonium chloride that can be absorbed by soft contact lenses and could irritate your eye. After you apply the drop, wait at least 15 minutes before putting your lenses back in.
Are there side effects I should watch out for beyond the usual eye irritation?
Most people experience only mild side effects like temporary eye redness, irritation, or stinging when they apply the drop. But call your doctor if you notice worsening eye pain, significant blurring of vision, or signs of eye infection like increasing redness or discharge. These could point to a more serious condition like eye inflammation or an infection that needs prompt attention.
Is Vyzulta safe to use during pregnancy or while breastfeeding?
This one needs a conversation with your doctor. There are no human safety data for Vyzulta during pregnancy, and animal studies showed serious fetal harm. It's not known whether the medication passes into breast milk either. If you are pregnant, trying to conceive, or breastfeeding, let your doctor know before using this medication so you can weigh the risks and benefits together.
Is Latanoprostene Bunod Ophthalmic available over the counter?
Latanoprostene Bunod Ophthalmic is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Latanoprostene Bunod Ophthalmic first available?
Latanoprostene Bunod Ophthalmic has been available in the United States since at least 2017, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Latanoprostene Bunod Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Latanoprostene Bunod Ophthalmic comes

Latanoprostene Bunod Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Vyzulta
How this form is used
What it may be used for
  • Vyzulta is used to reduce intraocular pressure in adults with open-angle glaucoma
  • Vyzulta is used to reduce intraocular pressure in adults with ocular hypertension
Important instructions
  • Vyzulta: instill one drop into the affected eye(s) once daily in the evening
  • Vyzulta: do not use more than once daily — more frequent use may reduce its pressure-lowering effect
  • Vyzulta: if using alongside other eye drops, wait at least 5 minutes between each product
  • Vyzulta: remove contact lenses before applying; wait 15 minutes before reinserting them (the preservative benzalkonium chloride can be absorbed by lenses)
Available strengths 1 strength
2 FDA-listed product records

📊 Latanoprostene Bunod Ophthalmic across the U.S. market

How Latanoprostene Bunod Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
2
FDA-listed product records
2017
First marketed

📈 How widely Latanoprostene Bunod Ophthalmic is used

A general measure of how commonly Latanoprostene Bunod Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Latanoprostene Bunod Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

13,742
Medicaid prescriptions filled (Q1–Q4 2025)
$4.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Latanoprostene Bunod Ophthalmic prescribed? Of the 1,594 medications we measure, Latanoprostene Bunod Ophthalmic ranks #875 by Medicaid prescriptions — more than 45% of them.

Where Latanoprostene Bunod Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Latanoprostene Bunod Ophthalmic product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

latanoprostene bunod 0.24 MG/ML Ophthalmic Solution

13,742 Medicaid prescriptions (Q1–Q4 2025) 100% of Latanoprostene Bunod Ophthalmic prescriptions shown $4.9M gross reimbursement (before rebates) ≈ $359 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1988394

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Latanoprostene Bunod Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 6 listed Latanoprostene Bunod Ophthalmic NDCs with Medicaid activity.

🔍 Compare Latanoprostene Bunod Ophthalmic products

A representative set of FDA-listed product records for Latanoprostene Bunod Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Eye drops
0.24 mg/mL Ophthalmic Bausch & Lomb Incorporated × 2 listings NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Latanoprostene Bunod Ophthalmic NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Latanoprostene Bunod Ophthalmic RxCUI 1988390 1 dose form · 1 strength
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 1988393 In current FDA listings
    Clinical drug / strength (SCD) 0.24 MG/ML RxCUI 1988394

Look up RxCUI 1988390 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Vyzulta

🏭 Manufacturers & labelers

Bausch & Lomb Incorporated 2

RxNorm drug class

Latanoprostene Bunod Ophthalmic belongs to the Prostaglandin analogues class.

Drug family (ATC) Prostaglandin analogues

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 27, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Latanoprostene Bunod Ophthalmic.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Latanoprostene Bunod Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label
Bausch & Lomb Incorporated
Linked label effective
Feb 27, 2024
Composite sections available
19
Linked SPL Set ID
60ce7900-a677-4fc2-88d0-1603baa9dbd4
Linked SPL Document ID
12648511-1ae2-aaf8-e063-6394a90a2297
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch & Lomb Incorporated is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.