Prescription medicine
Bupropion and dextromethorphan Brand names: Auvelity
Bupropion and dextromethorphan (Auvelity) is a prescription medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $19.90 per Auvelity ER 45-105 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the bupropion and dextromethorphan FDA label on DailyMed (effective August 17, 2026, Axsome Therapeutics, Inc.); the NDA 215430 record on Drugs@FDA; every bupropion and dextromethorphan label on DailyMed.
Highlights of the record
FDA label of August 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL THOUGHTS AND BEHAVIORS.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. AUVELITY is not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. AUVELITY is not approved for use in pediatric patients.
Used for
From the label: indications and usageAUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an
Forms and strengths
- 30 mg / 105 mg
- 45 mg / 105 mg
Kit; multilayer extended-release tablet.
On the market
- Earliest approval on file
- August 18, 2022 Auvelity, Axsome; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 28, 2043 Auvelity tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $19.90 per tablet Auvelity ER 45-105 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,287 through July 30, 2026
What is bupropion and dextromethorphan used for?
From the label: indications and usageAUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease (1.2). 1.1 Major Depressive Disorder AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults. 1.2 Agitation Associated with Dementia Due to Alzheimer’s Disease AUVELITY is indicated for the treatment of agitation associated with dementia due to Alzheimer’s disease. […]
Conditions named in the indications of bupropion and dextromethorphan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aminoketone, Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist.
Source: FDA drug label (AUVELITY), Axsome Therapeutics, Inc., effective August 17, 2026 (SPL set dcefda7c-9a68-278e-e053-2995a90aec79), via openFDA; the full label on DailyMed
What does the patient leaflet for bupropion and dextromethorphan 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 AUVELITY?AUVELITY may cause serious side effects, including: Increased risk of suicidal thoughts and actions. AUVELITY and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop 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 have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping (insomnia) suicide attempts new or worse anxiety panic attacks new or worse irritability acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) acting on dangerous impulses other unusual changes in behavior or mood See “What are the possible side effects of AUVELITY?” for more information about side effects.
From the patient leaflet: What should I avoid while taking AUVELITY?Limit or avoid using alcohol during treatment with AUVELITY. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures. Do not drive a car or use heavy machinery until you know how AUVELITY affects you. AUVELITY can affect your ability to do these things safely.
From the patient leaflet: How should I store AUVELITY?Store AUVELITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep AUVELITY in the bottle that it comes in. Keep AUVELITY and all medicines out of the reach of children.
Source: FDA drug label (AUVELITY), Axsome Therapeutics, Inc., effective August 17, 2026 (SPL set dcefda7c-9a68-278e-e053-2995a90aec79), via openFDA; the full label on DailyMed
Is there a generic for bupropion and dextromethorphan (Auvelity)?
No generic bupropion and dextromethorphan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 148 patents for Auvelity tablets, the last expiring on November 28, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bupropion and dextromethorphan (Auvelity)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $19.90 per Auvelity ER 45-105 mg tablet, up 6% from $18.76 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.
- Auvelity ER 45-105 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Auvelity ER 45-105 mg tablet | Brand | $19.90 per tablet | $596.93 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the bupropion and dextromethorphan label say about other medicines?
The bupropion and dextromethorphan label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amantadine | drug interactions | Dopaminergic Drugs Clinical Impact CNS toxicity was reported when bupropion was co-administered with levodopa or amantadine. Adverse reactions include restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness. |
| Cocaine | warnings and precautions | … disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); use of illicit drugs (e.g., cocaine); or abuse or misuse of prescription drugs such as CNS stimulants. |
| Digoxin | drug interactions | Digoxin Clinical Impact Coadministration of AUVELITY with digoxin may decrease plasma digoxin levels. Intervention Monitor plasma digoxin levels in patients treated concomitantly with AUVELITY and digoxin [see Clinical Pharmacology ( 12.3 )]. |
| Levodopa | drug interactions | Dopaminergic Drugs Clinical Impact CNS toxicity was reported when bupropion was co-administered with levodopa or amantadine. Adverse reactions include restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness. |
| Linezolid | contraindications | Starting AUVELITY in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated. with known hypersensitivity to bupropion, dextromethorphan, or other components of AUVELITY. |
| Methylene blue | contraindications | Starting AUVELITY in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated. with known hypersensitivity to bupropion, dextromethorphan, or other components of AUVELITY. |
| Nicotine | warnings and precautions | Monitor blood pressure in patients who receive the combination of bupropion and nicotine replacement. |
| Theophylline | warnings and precautions | CNS tumor or CNS infection; severe stroke; concomitant use of other medications that lower the seizure threshold (e.g., other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids); … |
Check bupropion and dextromethorphan against other medicines
Source: FDA drug label (AUVELITY), Axsome Therapeutics, Inc., effective August 17, 2026 (SPL set dcefda7c-9a68-278e-e053-2995a90aec79), via openFDA; the full label on DailyMed
What do FAERS reports show for bupropion and dextromethorphan?
The FDA Adverse Event Reporting System holds 3,287 reports that list bupropion and dextromethorphan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 33 are coded as a death and 179 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,091, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bupropion and dextromethorphan?
29 other medicines are given the same way (oral) and in the same FDA class as bupropion and dextromethorphan or labeled mainly for the same use (depression), the same class first. Depression lists all 37 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 |
|---|---|---|---|---|
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
| Paroxetine | Depression | 45 labelers | $0.0611 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as bupropion and dextromethorphan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bupropion and dextromethorphan
- 29 medicines for the same use
- Other aminoketones
- the pharmacologic class, with prices and generics
- Bupropion and dextromethorphan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other