FDA-filed SPL labeling · retrieved through openFDA

Levobunolol Ophthalmic

Levobunolol ophthalmic is a beta-blocker eye drop used to lower elevated eye pressure in people with chronic open-angle glaucoma or ocular hypertension.

Brand names AKBetaBetagan
Drug classes Adrenergic Beta-antagonists
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 effectiveJul 24, 2024
AvailabilityRx
Earliest approval/marketing year 1985
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Levobunolol Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Levobunolol ophthalmic solution is a proven eye drop for lowering eye pressure in chronic open-angle glaucoma and ocular hypertension. Because it is a beta-blocker, even as an eye drop it can affect the heart and lungs — so it is not safe for everyone, especially those with asthma or certain heart conditions. Use it exactly as prescribed, and keep your doctor informed of any new symptoms.

📖 Levobunolol Ophthalmic: Patient Information Guide

A plain-language walkthrough of Levobunolol 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

Levobunolol ophthalmic solution is used to lower intraocular pressure (pressure inside the eye). It is indicated for:

  • Chronic open-angle glaucoma — the most common form of glaucoma, where pressure slowly builds up and can damage the optic nerve over time
  • Ocular hypertension — elevated eye pressure that raises the risk of glaucoma, even before vision damage has occurred
⚙️How it works

Levobunolol is a non-selective beta-adrenergic blocker, meaning it blocks both beta-1 and beta-2 receptors equally. When applied to the eye, it reduces the production of aqueous humor — the clear fluid that fills the front of the eye. Less fluid made means less pressure building up inside the eye. Lowering that pressure protects the optic nerve and helps prevent vision loss.

Because it blocks both types of beta receptors (not just the heart-specific ones), it can also affect the lungs and cardiovascular system if absorbed into the bloodstream — which is why lung and heart conditions are important safety considerations with this medication.

💊How it's taken

Levobunolol ophthalmic solution is applied directly as eye drops into the affected eye or eyes. The typical starting dose is once daily. For more severe or uncontrolled eye pressure, it may be used twice daily — but going above twice-a-day dosing is not generally more effective.

  • Use it at the same time(s) each day to maintain steady pressure control
  • Do not use a second topical beta-blocker eye drop at the same time
  • If your pressure is not well controlled, your doctor may add another type of eye drop rather than increasing the dose
  • Follow your prescriber's instructions and your prescription label exactly — do not adjust your dose on your own
🤒Side effects — in detail

The most common side effects with levobunolol eye drops involve the eye itself, but some systemic (whole-body) effects can also occur because the drops are absorbed into the bloodstream.

  • Burning or stinging in the eye after applying drops (up to 1 in 3 patients)
  • Blepharoconjunctivitis (eyelid and eye surface irritation) — up to 1 in 20 patients
  • Decreased heart rate or blood pressure
  • Headache, dizziness, or fatigue
  • Decreased corneal sensitivity (reduced feeling on the eye surface), especially with long-term use
  • Itching, rash, or hives
  • Nausea or digestive upset

Serious reactions — including severe bronchospasm (airway tightening), dangerously slow heart rate, heart failure, or Stevens-Johnson Syndrome (a severe skin reaction) — have been reported and require immediate medical attention.

⚠️Warnings & precautions
  • Asthma / severe COPD: Do not use levobunolol if you have asthma or a history of asthma. Severe bronchospasm and deaths have been reported with beta-blocker eye drops in these patients. People with COPD, emphysema, or chronic bronchitis should generally avoid it as well.
  • Heart failure and slow heart rate: Beta-blockers can worsen heart failure and cause the heart to beat too slowly. Stop use and contact your doctor immediately at the first sign of heart failure symptoms.
  • Surgery: Tell your surgeon and anesthesiologist you use this medication. Beta-blockers can reduce the heart's response during anesthesia and cause prolonged low blood pressure.
  • Diabetes: This medication can hide the fast heartbeat that signals low blood sugar — especially important if you use insulin.
  • Thyroid disease: Can mask the racing heart that signals a thyroid problem. Never stop abruptly if hyperthyroidism is suspected — this could trigger a dangerous thyroid storm.
  • Sulfite allergy: The product contains sodium metabisulfite, which can cause allergic reactions including anaphylaxis in sensitive individuals, especially those with asthma.
  • Raynaud's phenomenon / circulation problems: Use with caution — this medication may worsen symptoms of poor circulation in the extremities.
🔀What it interacts with

Because levobunolol can be absorbed from the eye into the bloodstream, it can interact with other medications that affect the heart, lungs, or blood sugar.

  • Other topical beta-blocker eye drops: Should not be used together — additive effects on heart rate and blood pressure
  • Insulin and oral diabetes medications: Levobunolol can hide low blood sugar symptoms (especially fast heartbeat), making hypoglycemia harder to detect
  • Heart rate or blood pressure-lowering drugs: Combined use may cause excessive slowing of the heart or a dangerous drop in blood pressure
  • General anesthetics: Beta-blockers reduce the heart's ability to compensate during surgery and anesthesia — inform your medical team before any procedure

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
  • Do not use if you have bronchial asthma or a history of asthma — risk of severe or fatal bronchospasm
  • Do not use if you have severe COPD
  • Do not use if you have sinus bradycardia (abnormally slow heart rate), second- or third-degree heart block, overt heart failure, or cardiogenic shock
  • Do not use if you are allergic to any component of the product
  • Tell your doctor if you have mild or moderate COPD, emphysema, or other bronchospastic lung disease — caution is needed
  • Tell your doctor if you have diabetes, especially if you take insulin or are prone to low blood sugar
  • Tell your doctor if you have thyroid disease (hyperthyroidism)
  • Tell your doctor if you have Raynaud's phenomenon or other circulation problems
  • Tell your doctor if you have a sulfite sensitivity or allergy
  • Tell your doctor about all eye drops and other medications you are currently taking
  • Inform your surgeon or anesthesiologist before any planned surgery
🚑If you take too much

If too much levobunolol enters the eye or is accidentally swallowed, the most likely signs are a very slow heart rate, low blood pressure, bronchospasm (severe airway tightening), and acute heart failure. If accidental eye overdose occurs, flush the eye with water or normal saline. If swallowed, contact poison control or emergency services right away — further absorption may need to be prevented.

📡Pharmacodynamics — effects in the body

Levobunolol eye drops start lowering eye pressure within about one hour of a single drop, with the greatest effect occurring between 2 and 6 hours after use. A meaningful reduction in eye pressure can last for up to 24 hours after a single dose. In clinical studies lasting approximately two years, twice-daily use of the 0.5% solution controlled eye pressure in roughly 80% of patients, with an average reduction of 7–8 mm Hg from baseline. The drops do not significantly affect pupil size, tear production, or the eye's ability to focus (accommodation).

📦How to store it

Store between 15°C to 25°C (59°F to 77°F). Protect from light. KEEP OUT OF REACH OF CHILDREN.

📄 Written from Levobunolol 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 Levobunolol Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does levobunolol eye drops do for my eyes?
It lowers the pressure inside your eye. Too much pressure can slowly damage your optic nerve and lead to vision loss — that's the main danger with glaucoma. Levobunolol works by reducing the amount of fluid your eye produces, which brings that pressure down. The good news is that it starts working within about an hour of your first drop, and one dose can keep pressure controlled for up to 24 hours.
How often do I need to use these drops?
Most people start with one or two drops once a day. If your eye pressure isn't well controlled, your doctor may move you to twice a day. Using it more than twice a day doesn't add more benefit, so stick to what your prescriber tells you. Try to use it at the same time each day to keep things consistent.
My eye stings right after I put the drops in — is that normal?
Yes, burning or stinging right after applying the drops is actually very common — it happens in up to one in three people. It usually fades quickly on its own. If you also notice redness, irritation of the eyelid, or the discomfort is severe or lasting, let your doctor know — that could be a sign of blepharoconjunctivitis (irritation of the eyelid and eye surface) that may need attention.
Can an eye drop really affect my heart or breathing?
It can, yes — and this is one of the most important things to know. Even though you apply levobunolol to your eye, a small amount is absorbed into your bloodstream. It's a beta-blocker, so it can slow your heart rate and lower your blood pressure, and in people with asthma or lung disease it can trigger serious breathing problems. This is why it's contraindicated — meaning it must not be used — in anyone with asthma. If you ever notice your heart feels very slow, you feel faint, or you have trouble breathing, get medical help right away.
I have diabetes — is there anything special I should know?
Yes, this is worth flagging with your doctor. Beta-blockers like levobunolol can hide one of the main warning signs of low blood sugar: a racing heartbeat. You may still feel sweaty or shaky if your blood sugar drops, but you could miss the fast heart rate clue. Make sure your doctor knows you're diabetic and talk about how to monitor yourself safely while using this medication.
I'm scheduled for surgery — do I need to stop these drops beforehand?
This is something to discuss with both your eye doctor and your surgeon before the procedure. Beta-blockers can affect how your heart responds during general anesthesia, and some people experience prolonged low blood pressure. Your surgical team needs to know you're using these drops so they can plan accordingly. Don't stop them on your own without guidance — your prescriber will advise you on whether or when to pause them.
Is Levobunolol Ophthalmic available over the counter?
Levobunolol 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 Levobunolol Ophthalmic first available?
Levobunolol Ophthalmic has been available in the United States since at least 1985, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Levobunolol Ophthalmic?
Levobunolol Ophthalmic is supplied by 2 manufacturers listed in the FDA NDC Directory, including Bausch & Lomb Incorporated, Allergan, Inc..

💬 Answers drafted from Levobunolol 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 Levobunolol Ophthalmic comes

Levobunolol 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 Betagan
How this form is used
What it may be used for
  • Used to lower intraocular pressure in chronic open-angle glaucoma
  • Used to lower elevated eye pressure in ocular hypertension
Important instructions
  • Apply one to two drops into the affected eye(s) as directed — typically once daily, or twice daily for more severe or uncontrolled glaucoma
  • Do not use more than one drop twice a day — higher doses are not generally more effective
  • Do not use alongside another topical ophthalmic beta-blocker eye drop at the same time
  • If eye pressure remains uncontrolled, your prescriber may add another eye-pressure-lowering eye drop — follow their guidance carefully
Available strengths 1 strength
4 FDA-listed product records

📊 Levobunolol Ophthalmic across the U.S. market

How Levobunolol 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
2
Manufacturers
2
Brand names
4
FDA-listed product records
1985
First marketed
Bausch & Lomb Incorporated75%
Allergan, Inc.25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Levobunolol Ophthalmic is used

A general measure of how commonly Levobunolol 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 Levobunolol 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.

2,275
Medicaid prescriptions filled (Q1–Q4 2025)
$57,378 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Levobunolol Ophthalmic prescribed? Of the 1,596 medications we measure, Levobunolol Ophthalmic ranks #1,175 by Medicaid prescriptions — more than 26% of them.

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

Utilization by Levobunolol 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.

levobunolol hydrochloride 5 MG/ML Ophthalmic Solution

2,275 Medicaid prescriptions (Q1–Q4 2025) 100% of Levobunolol Ophthalmic prescriptions shown $57,378 gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1150836

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 Levobunolol 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 1 of 6 listed Levobunolol Ophthalmic NDCs with Medicaid activity.

🔍 Compare Levobunolol Ophthalmic products

A representative set of FDA-listed product records for Levobunolol 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
5 mg/mL Ophthalmic Allergan, Inc. NDA Find on DailyMed
5 mg/mL Ophthalmic Bausch & Lomb Incorporated × 3 listings ANDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Levobunolol 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) Levobunolol Ophthalmic RxCUI 1813 1 dose form · 2 strengths
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 377438 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 2.5 MG/ML RxCUI 1150832 hydrochloride 5 MG/ML RxCUI 1150836

Look up RxCUI 1813 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

AKBeta Betagan

🏭 Manufacturers & labelers

Bausch & Lomb Incorporated 3 Allergan, Inc. 1

RxNorm drug class

Levobunolol Ophthalmic belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents
How it works Adrenergic beta-Antagonists

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 Jul 24, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Levobunolol 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 Levobunolol Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
2
Linked representative label
Bausch & Lomb Incorporated
Linked label effective
Jul 24, 2024
Composite sections available
13
Linked SPL Set ID
5ab1efbe-530b-4787-b40a-c7dbf18161e1
Linked SPL Document ID
1e033456-2f30-9208-e063-6394a90a094f
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.