Prescription medicine
Viloxazine Brand names: Qelbree
Viloxazine (Qelbree) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $12.74 per Qelbree ER 200 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the viloxazine FDA label on DailyMed (effective December 5, 2025, Supernus Pharmaceuticals, Inc); the NDA 211964 record on Drugs@FDA; every viloxazine label on DailyMed.
Highlights of the record
FDA label of December 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL THOUGHTS AND BEHAVIORS.
In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. In clinical trials, higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).
Used for
From the label: indications and usageQelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Forms and strengths
- 100 mg
- 150 mg
- 200 mg
Extended-release capsule.
On the market
- Earliest approval on file
- April 2, 2021 Qelbree, Supernus Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 2, 2035 Qelbree capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $12.74 per capsule Qelbree ER 200 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is viloxazine used for?
From the label: indications and usageQelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older
Conditions named in the indications of viloxazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (QELBREE), Supernus Pharmaceuticals, Inc, effective December 5, 2025 (SPL set aedf408d-0f84-418d-9416-7c39ddb0d29a), via openFDA; the full label on DailyMed
What does the patient leaflet for viloxazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about QELBREE?QELBREE can cause serious side effects, including: Increased risk of suicidal thoughts or actions. QELBREE may increase suicidal thoughts or actions in children and adults with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions. This is very important when QELBREE treatment is started or when the dose is changed. Call your healthcare provider right away if you or your child has any new or sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develops suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you or your child has any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide new or worse depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) thoughts about suicide or dying new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood See " What are the possible side effects of QELBREE? " for more information about side effects.
From the patient leaflet: What should I avoid while taking QELBREE?Do not drive or operate heavy machinery until you know how QELBREE will affect you. QELBREE may cause you to feel sleepy or tired.
From the patient leaflet: How should I store QELBREE?Store QELBREE capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep QELBREE and all medicines out of the reach of children. General Information about the safe and effective use of QELBREE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take QELBREE for a condition for which it was not prescribed. Do not give QELBREE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about QELBREE that is written for health professionals.
Source: FDA drug label (QELBREE), Supernus Pharmaceuticals, Inc, effective December 5, 2025 (SPL set aedf408d-0f84-418d-9416-7c39ddb0d29a), via openFDA; the full label on DailyMed
Is there a generic for viloxazine (Qelbree)?
No generic viloxazine is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 6 patents for Qelbree capsules, the last expiring on April 2, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for viloxazine (Qelbree)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12.74 per Qelbree ER 200 mg capsule, up 6% from $12.05 on October 8, 2025. 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.
- Qelbree ER 200 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Qelbree ER 100 mg capsule | Brand | $12.73 per capsule | $381.98 | +6% |
| Qelbree ER 150 mg capsule | Brand | $12.73 per capsule | $381.93 | +6% |
| Qelbree ER 200 mg capsule | Brand | $12.74 per capsule | $382.14 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What else is labeled for the same conditions as viloxazine?
10 other medicines are given the same way (oral) and in the same FDA class as viloxazine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Guanfacine | ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as viloxazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to viloxazine
- 10 medicines for the same use
- Other norepinephrine reuptake inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other