Viloxazine
Viloxazine is a selective norepinephrine reuptake inhibitor used to treat Attention-Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 and older.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Qelbree carries a boxed warning — the FDA's most serious safety alert — about an increased risk of suicidal thoughts and behaviors. In clinical studies, patients with ADHD who took Qelbree were more likely to report suicidal thoughts or behaviors than those who took a placebo. This risk applies to both children and adults. Watch for warning signs such as new or worsening depression, unusual mood changes, agitation, or any talk about self-harm or suicide. If any of these appear, contact a healthcare provider right away. Family members and caregivers play an important role in monitoring and should feel empowered to seek help immediately if they notice these signs.
📖 Viloxazine: Patient Information Guide
A plain-language walkthrough of Viloxazine — 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▾
Viloxazine is approved for the treatment of ADHD. Here is what the evidence supports:
- Qelbree (viloxazine extended-release capsule) treats ADHD in adults (18 and older)
- Qelbree treats ADHD in children and adolescents 6 to 17 years of age
- Qelbree is not approved for use in children under 6 years old
⚙️How it works▾
Viloxazine works primarily by blocking the norepinephrine transporter — a protein that pulls norepinephrine (a brain chemical tied to attention, focus, and impulse control) back into nerve cells after it's released. Blocking this transporter keeps norepinephrine available longer in the brain. Viloxazine also partially activates a serotonin receptor called 5-HT2C, though the exact way these combined actions improve ADHD symptoms is not fully known.
Importantly, viloxazine is not a stimulant. It does not work the same way as amphetamine- or methylphenidate-based ADHD medications.
💊How it's taken▾
Qelbree is taken by mouth once daily, with or without food. The capsule should be swallowed whole — do not cut, crush, or chew it. If needed, the capsule can be opened and its entire contents sprinkled over applesauce or pudding and consumed without chewing within the specified time window.
- Doses are typically started low and increased gradually based on response and tolerability
- People with severe kidney disease require a lower maximum dose — ask your prescriber
- Your prescriber will periodically reassess whether long-term use is still needed
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Sleepiness, sedation, or lethargy
- Decreased appetite
- Fatigue
- Nausea
- Trouble sleeping (insomnia)
- Irritability
- Headache
- Vomiting
- In adults specifically: dry mouth, constipation, and dizziness were also commonly reported
Call your doctor promptly if you notice a fast heartbeat, significant mood changes, signs of mania, or any thoughts of self-harm — these are serious reactions that need immediate attention.
⚠️Warnings & precautions▾
Suicidal thoughts and behaviors: This is the most critical warning. In clinical trials, Qelbree-treated patients with ADHD reported suicidal thoughts or behaviors more often than those on placebo. Watch closely — especially during the first months of therapy or after dose changes — for new or worsening depression, agitation, unusual mood shifts, or any mention of self-harm. Report these signs to a healthcare provider immediately.
- Increased heart rate and blood pressure: Qelbree can raise both. Heart rate and blood pressure should be checked before starting, after dose increases, and periodically during treatment.
- Drowsiness and fatigue: Qelbree can cause significant sleepiness. Do not drive or operate heavy machinery until you know how it affects you.
- Mania or hypomania: Qelbree may trigger a manic or mixed episode in people with bipolar disorder. A psychiatric history screening is required before starting.
- Weight changes in children: Qelbree-treated children gained less weight than those on placebo in short-term studies. Monitor weight and growth during long-term use.
🔀What it interacts with▾
Viloxazine affects how the liver processes several other medications — some combinations are dangerous. Key interactions include:
- MAOIs (e.g., phenelzine, selegiline): Contraindicated — combining these can cause a potentially fatal spike in blood pressure (hypertensive crisis). Wait at least 14 days after stopping an MAOI before starting Qelbree.
- Sensitive CYP1A2 substrates or narrow-therapeutic-range CYP1A2 substrates (certain antipsychotics, theophylline, and others): Contraindicated — viloxazine strongly raises blood levels of these drugs, increasing the risk of serious side effects.
- Moderate sensitive CYP1A2 substrates: Not recommended together; dose reduction of the other drug may be warranted if unavoidable.
- CYP2D6 substrates (certain antidepressants, antipsychotics, heart medications): Viloxazine can modestly raise their levels — monitor for side effects and adjust doses as needed.
- CYP3A4 substrates (various medications): Viloxazine can modestly raise their levels — monitor accordingly.
- Heavy alcohol use: Drinking beverages with very high alcohol content can reduce viloxazine levels in the body.
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▾
The following people should talk to their prescriber or pharmacist carefully before starting viloxazine:
- Anyone with a personal or family history of bipolar disorder, depression, or suicidal thoughts — screening is required before starting
- Anyone with a history of high blood pressure or heart conditions — heart rate and blood pressure monitoring is needed
- People with severe kidney disease — a reduced dose is required
- Pregnant people — animal studies showed potential harm; Qelbree should be discontinued when pregnancy is recognized unless the benefits clearly outweigh the risks. A pregnancy registry is available at 1-866-961-2388.
- Breastfeeding people — viloxazine passes into breast milk in small amounts; discuss risks and benefits with your doctor
- Children under 6 years old — Qelbree is not approved for this age group
- Adults 65 and older — clinical trials did not include enough older adults to fully assess safety in this group; use with caution and under close medical supervision
- Anyone taking MAOIs, CYP1A2 substrates, or other interacting medications — review your full medication list with your prescriber before starting
🚑If you take too much▾
In reports from post-marketing experience with immediate-release viloxazine, overdoses have been associated mainly with drowsiness, but also with impaired consciousness, reduced reflexes, and increased heart rate. There is no specific antidote for a Qelbree overdose. If an overdose is suspected, call Poison Control immediately at 1-800-222-1222 or go to the nearest emergency room.
📡Pharmacodynamics — effects in the body▾
Viloxazine blocks the norepinephrine transporter, keeping norepinephrine active longer between nerve cells. It also partially activates serotonin 5-HT2C receptors. At doses up to three times the maximum recommended daily dose, Qelbree did not meaningfully affect the heart's QT interval (the electrical recovery time between heartbeats) — meaning it is not expected to cause a dangerous heart rhythm problem at therapeutic doses. However, lab studies suggest a potential to affect cardiac sodium channels, so heart monitoring remains part of routine care.
🔬Pharmacokinetics — how your body processes it▾
After taking Qelbree, peak blood levels are typically reached in about 5 hours (range: 3 to 9 hours), and steady levels in the body are achieved after about two days of once-daily dosing. The drug's half-life — the time for half of it to leave the body — is roughly 7 hours. Viloxazine is mainly broken down by liver enzymes (CYP2D6, UGT1A9, and UGT2B15) and is cleared primarily through the urine, with about 90% of a dose recovered there within 24 hours. Food has only a small effect on absorption, though a high-fat meal slightly delays the time to peak levels.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
📄 Written from Viloxazine’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 Viloxazine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Qelbree and how is it different from other ADHD medications? ▾
I heard there's a serious warning about suicidal thoughts — should I be worried? ▾
How do I take it — do I have to swallow the capsule whole? ▾
What side effects are most common, and which ones mean I should call my doctor? ▾
Are there medications or supplements I need to avoid while taking Qelbree? ▾
Is it safe to take during pregnancy or while breastfeeding? ▾
Is Viloxazine available over the counter? ▾
When was Viloxazine first available? ▾
Who makes Viloxazine? ▾
💬 Answers drafted from Viloxazine’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 Viloxazine comes
Viloxazine 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.
Extended-release capsule
How this form is used
- Qelbree is used to treat ADHD in adults
- Qelbree is used to treat ADHD in children and adolescents 6 to 17 years of age
- Qelbree capsules can be swallowed whole or opened and sprinkled over a teaspoon or tablespoon of applesauce or pudding — do not cut, crush, or chew the capsule or its contents
- Qelbree can be taken with or without food, but a high-fat meal may slightly delay absorption
- If sprinkled on pudding, the mixture must be eaten within 15 minutes; if sprinkled on applesauce, it must be eaten within 2 hours — do not store for later
- Qelbree is taken once daily; follow your prescriber's instructions for timing and dose adjustments
📊 Viloxazine across the U.S. market
How Viloxazine 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.
Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Viloxazine is used
A general measure of how commonly Viloxazine 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 Viloxazine 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.
How commonly is Viloxazine prescribed? Of the 1,596 medications we measure, Viloxazine ranks #274 by Medicaid prescriptions — more than 83% of them.
Utilization by Viloxazine 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.
24 HR viloxazine 200 MG Extended Release Oral Capsule Most dispensed
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2536756
24 HR viloxazine 100 MG Extended Release Oral Capsule
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2536548
24 HR viloxazine 150 MG Extended Release Oral Capsule
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2536750
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 Viloxazine, 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 4 of 18 listed Viloxazine NDCs with Medicaid activity.
🔍 Compare Viloxazine products
A representative set of FDA-listed product records for Viloxazine — 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 |
|---|---|---|---|---|
| 💊Extended-release capsule | ||||
| 100 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | Oral | Supernus Pharmaceuticals, Inc × 3 listings | NDA | View NDC → |
| 150 mg | Oral | Supernus Pharmaceuticals, Inc × 3 listings | NDA | View NDC → |
| 200 mg | Oral | Supernus Pharmaceuticals, Inc × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Anonima Materie Sintetiche and Affini (AMSA) Spa | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Bachem SA, succursale de Vionnaz | BULK INGREDIENT | View NDC → |
| 60 kg/60 kg | — | Biophore India Pharmaceuticals Pvt. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Granules India Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Maithri Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Neuland Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viloxazine Hydrochloride | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viyash Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viyash Scientific Limited | BULK INGREDIENT | View NDC → |
Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Viloxazine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Viloxazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Viloxazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Viloxazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 11196 1 dose form · 3 strengths
-
Dose form (SCDF) Extended Release Oral Capsule RxCUI 2536547In current FDA listingsClinical drug / strength (SCD) 24 HR viloxazine 100 MGRxCUI 253654824 HR viloxazine 150 MGRxCUI 253675024 HR viloxazine 200 MGRxCUI 2536756
Look up RxCUI 11196 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.
📦 Supply & shortage status
Whether Viloxazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Viloxazine belongs to the Norepinephrine Reuptake Inhibitor class.
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.
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.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Supernus Pharmaceuticals, 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.