FDA-filed SPL labeling · retrieved through openFDA

Apraclonidine Ophthalmic

Apraclonidine ophthalmic solution is an eye drop used to lower elevated intraocular pressure (IOP) in patients with glaucoma who need extra pressure control beyond their current medications.

Brand names IopidineIopidine 1%
Drug classes ⓘ Adrenergic Alpha-agonists
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 3 clinical label sets 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 effectiveOct 2, 2024
Clinical labels in scope ⓘ3
AvailabilityRx
Earliest approval/marketing year ⓘ1987
FDA-listed product records ⓘ6
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Apraclonidine Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Apraclonidine 0.5% eye drops are a short-term add-on option for lowering intraocular pressure in glaucoma patients who can't get enough control from their other medications alone. The effect may diminish within a month for some people, and allergic eye reactions are common. Because some medication is absorbed into the body, it can affect your heart rate and blood pressure — especially in very young children, where it can cause serious breathing problems.

📖 Apraclonidine Ophthalmic: Patient Information Guide

A plain-language walkthrough of Apraclonidine 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▾

Apraclonidine ophthalmic solution is used to lower intraocular pressure (IOP) in the eye. Here are the supported uses based on the available product evidence:

  • Apraclonidine Ophthalmic Solution 0.5% is approved as short-term add-on (adjunctive) therapy for patients with glaucoma who are already on maximally tolerated medical therapy but still need further IOP reduction.
  • Apraclonidine Ophthalmic Solution 0.5% may be used to delay the need for surgery (such as laser trabeculoplasty or trabeculectomy) in patients with uncontrolled IOP.
  • Note: Adding Apraclonidine 0.5% to a regimen that already includes two aqueous suppressants (such as a beta-blocker plus a carbonic anhydrase inhibitor) may not provide meaningful additional benefit, since it works by the same mechanism.
⚙️How it works▾

Apraclonidine is an alpha-2 adrenergic agonist — it activates specific receptors in the eye that signal the eye to produce less aqueous humor (the fluid that circulates inside the eye). Less fluid means less pressure building up. The effect starts within about one hour and peaks around three hours after the drops are placed in the eye. It works primarily by reducing fluid production rather than increasing fluid drainage.

In some patients, the pressure-lowering effect fades over time — a phenomenon called tachyphylaxis. This loss of effect varies from person to person and can happen unpredictably, which is why close monitoring is important during treatment.

💊How it's taken▾

Apraclonidine Ophthalmic Solution 0.5% is instilled as one to two drops into the affected eye(s) three times a day. If you use other eye drop medications alongside it, wait about 5 minutes between each drop to prevent one from washing the other away before it can work.

  • For eye (topical ophthalmic) use only — never inject or swallow.
  • Follow your prescriber's exact instructions; your doctor will adjust or stop treatment based on how your eye pressure responds.
🤒Side effects — in detail▾

Most side effects affect the eye itself and are the most common reason people stop treatment. Here's what to expect:

  • Eye discomfort or irritation
  • Redness of the eye (hyperemia)
  • Itching (pruritus) — one of the most common reasons for stopping
  • Tearing
  • Blurred vision
  • Eyelid swelling (lid edema)
  • Dry eye or foreign body sensation
  • Dry mouth — reported in about 10% of patients

Less common but more serious reactions include slow heartbeat (bradycardia), irregular heart rhythm (arrhythmia), chest pain, significant dizziness, and allergic-type reactions affecting the eye or skin. Contact your doctor right away if any of these occur.

⚠️Warnings & precautions▾
  • Serious risk in young children: Apraclonidine eye drops have caused cardiovascular collapse requiring breathing support, apnea (stopped breathing), and dangerously low blood pressure in children 6 years and younger, including newborns. Extreme caution and close clinical monitoring are required if used in this age group.
  • Systemic absorption: Even though it's an eye drop, apraclonidine is absorbed into the bloodstream and can lower blood pressure and slow the heart rate. People taking heart or blood pressure medications need close monitoring.
  • Loss of effect over time: The pressure-lowering benefit can fade within a month or less in some patients (tachyphylaxis). Your doctor will watch for this.
  • Allergic reactions: Eye redness, itching, and swelling are relatively common and were the main reason people stopped treatment in clinical trials. Stop use and contact your doctor if these occur.
  • For eye use only: Not for injection into the eye. Not for swallowing.
🔀What it interacts with▾

Apraclonidine can interact with several medications. Let your doctor and pharmacist know everything you take, including eye drops:

  • MAO inhibitors (a type of antidepressant, e.g., phenelzine, tranylcypromine) — contraindicated; do not use together.
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) — may reduce apraclonidine's pressure-lowering effect and can affect how the body handles certain chemical messengers.
  • CNS depressants (alcohol, barbiturates, opiates, sedatives, anesthetics) — may add to sedation and blood pressure lowering effects.
  • Beta-blockers (eye drops or pills), antihypertensives, and cardiac glycosides — may cause an added drop in blood pressure or heart rate; pulse and blood pressure should be monitored frequently.
  • Neuroleptic (antipsychotic) medications — combined with clonidine-type drugs, may cause an added drop in blood pressure.

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 are allergic to apraclonidine, clonidine, or any component of the drops.
  • Do not use if you currently take MAO inhibitor medications.
  • Tell your doctor about all heart or blood pressure medications you take — including eye drops.
  • Tell your doctor about all antidepressants you take, especially tricyclic antidepressants.
  • Use with extreme caution in children 6 years of age and younger, including newborns — serious and life-threatening reactions have been reported.
  • Tell your doctor about all other glaucoma eye drops you use, as timing of drops matters.
🚑If you take too much▾

If apraclonidine eye drops are accidentally swallowed, they can cause slow heartbeat (bradycardia), drowsiness, and low body temperature (hypothermia). Seek emergency medical help immediately if this happens. Treatment focuses on supportive care and keeping the airway open; hemodialysis removes very little of the drug from the body and is not considered an effective treatment.

📡Pharmacodynamics — effects in the body▾

Apraclonidine lowers intraocular pressure by reducing the production of aqueous humor — the fluid that flows through the eye. It achieves this by stimulating alpha-2 adrenergic receptors, which signal the eye to produce less fluid. The drop in pressure begins within about one hour and reaches its peak effect around three hours after the drops are applied. Because it is a vasoconstrictor (it narrows blood vessels), it has been shown to reduce blood flow to the front part of the eye in animal studies, though effects on the back of the eye were not seen.

🔬Pharmacokinetics — how your body processes it▾

Although apraclonidine is applied to the eye surface, it is absorbed into the bloodstream. In studies of healthy volunteers using one drop three times a day in both eyes for 10 days, blood levels were low but measurable. The half-life — the time it takes the body to clear half the drug — is approximately 8 hours. Because of this systemic absorption, effects on heart rate and blood pressure are possible even with eye drop use.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) . Protect from freezing and light.

📄 Written from Apraclonidine 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 →

18

Supplements & herbs that interact with Apraclonidine Ophthalmic

18 supplements and herbal products have documented interactions with Apraclonidine Ophthalmic in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 8
  • Minor · 9
Every supplement checked against Apraclonidine Ophthalmic — ranked by severity The full interaction hub: 1 major · 8 moderate · 9 minor · every one linked to its full report. Check Apraclonidine Ophthalmic against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What is apraclonidine eye drops actually used for? ▾
It's used to lower the pressure inside your eye — called intraocular pressure or IOP — when you have glaucoma. It's specifically for people who are already using as many glaucoma medications as they safely can but still need a little more pressure control. It's considered a short-term add-on, not a standalone long-term treatment.
How do I use the drops, and what if I use other eye drops too? ▾
Place one to two drops into your affected eye(s) three times a day. If you use other eye drops, wait about 5 minutes between each one — this prevents the first drop from being rinsed away before it has time to work. These drops go on the eye surface only; never inject them or swallow them.
What side effects should I expect, and which ones mean I should call my doctor? ▾
The most common issues are eye redness, itching, and discomfort — these were actually the main reason people stopped using it in studies. Dry mouth affects about 1 in 10 people. You should call your doctor right away if you notice a severe allergic reaction (intense swelling or itching in or around the eye), a slow or irregular heartbeat, chest pain, significant dizziness, or trouble breathing.
Will these drops keep working long term? ▾
Not always. For many people, the pressure-lowering effect starts to wear off over time — sometimes within a month. This is called tachyphylaxis and it varies from person to person. That's why your doctor will monitor your eye pressure closely and may change your treatment plan if the drops stop working well enough.
Are there any medications I absolutely cannot take with these eye drops? ▾
Yes — you must not use apraclonidine if you take MAO inhibitor antidepressants (such as phenelzine or tranylcypromine). That combination is contraindicated, meaning it's considered unsafe. You should also let your doctor know if you take tricyclic antidepressants, blood pressure medications, beta-blockers, heart medications, sedatives, or anything that makes you drowsy, as apraclonidine can interact with all of these.
Is it safe to use these drops in children? ▾
This is a serious concern. Apraclonidine eye drops have caused life-threatening reactions in children 6 years old and younger — including cardiovascular collapse, stopped breathing, and very low blood pressure. If a child needs these drops, it must only be done under very close medical supervision. Keep the bottle well out of reach of children, and seek emergency help immediately if a child accidentally swallows any of this medication.
Is Apraclonidine Ophthalmic available over the counter? ▾
Apraclonidine 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 Apraclonidine Ophthalmic first available? ▾
Apraclonidine Ophthalmic has been available in the United States since at least 1987, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Apraclonidine Ophthalmic? ▾
Apraclonidine Ophthalmic is supplied by 4 manufacturers listed in the FDA NDC Directory, including Harrow Eye, LLC, Sandoz Inc, Akorn.

💬 Answers drafted from Apraclonidine 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 Apraclonidine Ophthalmic comes

Apraclonidine 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 Iopidine Iopidine 1%
How this form is used
What it may be used for
  • Apraclonidine Ophthalmic Solution 0.5% is used as short-term add-on therapy to lower intraocular pressure in glaucoma patients who are already on maximum tolerated medical therapy
  • Apraclonidine Ophthalmic Solution 0.5% may be used to help delay the need for eye surgery in patients with uncontrolled intraocular pressure
Important instructions
  • Apraclonidine Ophthalmic Solution 0.5%: instill one to two drops into the affected eye(s) three times daily
  • If using other eye drop medications, wait approximately 5 minutes between each drop to avoid washing out the previous dose
  • For topical (eye surface) use only — do not inject into the eye and do not swallow
  • Follow your prescriber's instructions closely; your doctor will monitor your eye pressure regularly during treatment
Available strengths 3 strengths
6 FDA-listed product records ⓘ

📊 Apraclonidine Ophthalmic across the U.S. market

How Apraclonidine 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 ⓘ
4
Manufacturers
4
Brand names
6
FDA-listed product records ⓘ
1987
First marketed ⓘ
Harrow Eye, LLC33%
Sandoz Inc33%
Akorn17%
Alcon Laboratories, Inc.17%

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

📈 How widely Apraclonidine Ophthalmic is used

A general measure of how commonly Apraclonidine 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 Apraclonidine 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.

593
Medicaid prescriptions filled (Q1–Q4 2025)
$36,731 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Apraclonidine Ophthalmic prescribed? Of the 1,597 medications we measure, Apraclonidine Ophthalmic ranks #1,350 by Medicaid prescriptions — more than 15% of them.

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

Utilization by Apraclonidine 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.

apraclonidine 5 MG/ML Ophthalmic Solution

593 Medicaid prescriptions (Q1–Q4 2025) 100% of Apraclonidine Ophthalmic prescriptions shown $36,731 gross reimbursement (before rebates) ≈ $62 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308345

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 Apraclonidine 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 4 listed Apraclonidine Ophthalmic NDCs with Medicaid activity.

🔍 Compare Apraclonidine Ophthalmic products

A representative set of FDA-listed product records for Apraclonidine 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 Akorn ANDA View NDC →
10 mg/mL Ophthalmic Alcon Laboratories, Inc. NDA Find on DailyMed ↗
10 mg/mL Ophthalmic Harrow Eye, LLC × 2 listings NDA View NDC →
5.75 mg/mL Ophthalmic Sandoz Inc × 2 listings NDA AUTHORIZED GENERIC View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Apraclonidine 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) Apraclonidine Ophthalmic RxCUI 14845 1 dose form · 2 strengths
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 379111 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 308345 10 MG/ML RxCUI 308346

Look up RxCUI 14845 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

Iopidine Iopidine 1%

🏭 Manufacturers & labelers

Harrow Eye, LLC 2 Sandoz Inc 2 Akorn 1 Alcon Laboratories, Inc. 1

RxNorm drug class

Apraclonidine Ophthalmic belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Sympathomimetics in glaucoma therapy
How it works Adrenergic alpha-Agonists

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 Oct 2, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Apraclonidine 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 Apraclonidine Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
6
Distinct labelers/manufacturers represented
4
Linked representative label ⓘ
Sandoz Inc
Linked label effective
Oct 2, 2024
Composite sections available
16
Linked SPL Set ID
04ad82af-e7ba-4f40-a120-be9d33cf0c7b
Linked SPL Document ID
238af96f-2f89-9af4-e063-6394a90a9516
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 3 FDA-filed SPL label sets 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. Sandoz Inc 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.