Dextromethorphan hydrobromide, bupropion hydrochloride

What Dextromethorphan hydrobromide, bupropion hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

AUVELITY 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 the treatment of agitation associated with dementia due to Alzheimer’s disease Limitations of Use …

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, multilayer, extended release, oral), Auvelity, Axsome Therapeutics, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

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Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Read it on the full label →

Dextromethorphan hydrobromide, bupropion hydrochloride boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: 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)].

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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. (5.1, 8.4)

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. Read the full label on DailyMed →

Dextromethorphan hydrobromide, bupropion hydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Seizure [see Warnings and Precautions (5.2)] Increased Blood Pressure and Hypertension [see Warnings and Precautions (5.3)] Activation of Mania or Hypomania [see Warnings and Precautions (5.4)] Psychosis and Other Neuropsychiatric Reactions [see Warnings and Precautions (5.5)] …

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. This is part of the section. Read the full label on DailyMed →

Dextromethorphan hydrobromide, bupropion hydrochloride drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Strong CYP2D6 inhibitors: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, maximum recommended dosage is one tablet of 45 mg dextromethorphan hydrobromide/105 mg bupropion hydrochloride by mouth once daily in the morning. (2.5, 7.1) Strong CYP2B6 inducers: Avoid use. (7.1) CYP2D6 Substrates: Increases the exposures of drugs that are substrates of CYP2D6. (7.1) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.

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(7.1) Drugs that lower seizure threshold: Coadministration may increase risk of seizure. (7.1) Dopaminergic drugs: Central Nervous System (CNS) toxicity can occur with concomitant use. (7.1) Drug-laboratory test interactions: AUVELITY can cause false-positive urine test results for amphetamines. (7.2) 7.1 Drugs Having Clinically Important Interactions with AUVELITY Table 4: Clinically Important Drug Interactions with AUVELITY Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of AUVELITY with MAOIs increases the risk of hypertensive crisis and serotonin syndrome. Intervention AUVELITY is contraindicated in patients taking MAOIs (including MAOIs such as linezolid or intravenous methylene blue) or in patients who have taken MAOIs within the preceding 14 days. Allow at least 14 days after stopping AUVELITY before starting an MAOI [see Dosage and Administration (2.7), Contraindications (4), Warnings and Precautions (5.3, 5.8)] Serotonergic Drugs Clinical Impact Concomitant use of AUVELITY with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when AUVELITY is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of AUVELITY and/or concomitant serotonergic drug [see Dosage and Administration (2.1), Warnings and Precautions (5.8)]. Drugs that Lower Seizure Threshold Clinical Impact AUVELITY contains bupropion which can cause seizure. Co-administration with other drugs that lower seizure threshold may increase risk of seizure. Intervention Use caution when administering AUVELITY concomitantly with drugs that lower the seizure threshold [see Warnings and Precautions (5.2)]. Discontinue AUVELITY and do not restart treatment if the patient experiences a seizure. Strong Inhibitors of CYP2D6 Clinical Impact Concomitant use of AUVELITY with strong CYP2D6 inhibitors increases plasma concentrations of dextromethorphan. Intervention Dosage adjustment is necessary when AUVELITY is co-administered with strong inhibitors of CYP2D6 [see Dosage and Administration (2.5)]. Monitor patients for adverse reactions potentially attributable to dextromethorphan, such as somnolence and dizziness. Strong Inducers of CYP2B6 Clinical Impact Concomitant use of AUVELITY with strong CYP2B6 inducers decreases plasma concentrations of dextromethorphan and bupropion and may decrease efficacy of AUVELITY [see Clinical Pharmacology (12.3)]. Intervention Avoid co-administration of AUVELITY with strong inducers of CYP2B6. Consider alternatives to strong CYP2B6 inducers if needed.

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. This is part of the section. Read the full label on DailyMed →

Dextromethorphan hydrobromide, bupropion hydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Prior to initiating treatment with AUVELITY: assess blood pressure; screen patients for history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan. (2.1) For MDD, the starting dosage is AUVELITY 45 mg/105 mg once daily in the morning. On day 4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours.

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Do not exceed two doses within the same day. (2.2) For agitation associated with dementia due to Alzheimer’s disease, the starting dosage is AUVELITY 30 mg/105 mg once daily in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. On day 15, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. Do not exceed two doses within the same day. (2.3) Swallow tablets whole, do not crush, divide, or chew. (2.2, 2.3) Moderate renal impairment: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning. (2.4, 8.6) CYP2D6 poor metabolizers: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning. (2.6, 8.8, 12.3) 2.1 Important Recommendations Prior to Initiating and During Treatment with AUVELITY Prior to initiating and during treatment with AUVELITY: assess blood pressure and monitor periodically during treatment [see Warnings and Precautions (5.3)]. screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)]. screen patients to determine if they are receiving any other medications that contain bupropion or dextromethorphan [see Warnings and Precautions (5.2, 5.5, 5.8)]. 2.2 Recommended Dosage for the Treatment of Major Depressive Disorder The recommended starting dosage ofis AUVELITY (45 mg of dextromethorphan hydrobromide and /105 mg of bupropion hydrochloride) is one tablet once daily in the morning. After 3 daysOn day 4, increase to the maximum recommended dosage of one tablet twice daily, given at least 8 hours apart. Do not exceed two doses within the same day. Administer AUVELITY orally with or without food [see Clinical Pharmacology (12.3)]. Swallow tablets whole, do not crush, divide, or chew. 2.3 Recommended Dosage for Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease The recommended titration schedule is as follows: The recommended starting dose is AUVELITY 30 mg/105 mg once daily, in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability. On day 15, after starting AUVELITY, increase to the maximum recommended dosage of 45 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability. Do not exceed two doses within the same day. Administer AUVELITY orally with or without food [see Clinical Pharmacology (12.3)].

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. This is part of the section. Read the full label on DailyMed →

Dextromethorphan hydrobromide, bupropion hydrochloride in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including AUVELITY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or online at: https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

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Risk Summary Based on animal studies, AUVELITY may cause fetal harm when administered during pregnancy. AUVELITY is not recommended during pregnancy. If a female becomes pregnant while being treated with AUVELITY, discontinue treatment and counsel the patient about the potential risk to a fetus [see Warnings and Precautions (5.9)]. In oral studies conducted in rats and rabbits, a combination of dextromethorphan/quinidine demonstrated developmental toxicity, including fetal malformations (rabbits) and embryolethality, when given to pregnant animals. When bupropion alone was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 21 times the maximum recommended human dose (MRHD) of 210 mg/day. When bupropion alone was given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately 2 to 5 times the MRHD and greater. Decreased fetal weights were seen at bupropion doses approximately 5 times the MRHD and greater. Neurotoxicity findings were observed in juvenile rats treated with a combination of dextromethorphan/quinidine on postnatal day (PND) 7, which corresponds to the third trimester of gestation through the first few months of life and may extend through the first three years of life in humans. Based on these findings, AUVELITY may cause fetal harm when administered to pregnant women (see Data). The available clinical data on the use of AUVELITY during pregnancy is insufficient to evaluate for a drug-associated risk of major birth malformations, miscarriage, or other adverse maternal or fetal outcomes. However, there are available data on one of the individual components of AUVELITY, bupropion. Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data). There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy.

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. This is part of the section. Read the full label on DailyMed →

When Dextromethorphan hydrobromide, bupropion hydrochloride should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

AUVELITY is contraindicated in patients: with a seizure disorder [see Warnings and Precautions (5.2)]. with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions (5.2)]. undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome [see Dosage and Administration (2.7), Warnings and Precautions (5.8), Drug Interactions (7.1)].

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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. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with bupropion. Arthralgia, myalgia, fever with rash, and other serum sickness-like symptoms suggestive of delayed hypersensitivity have also been reported with bupropion [see Adverse Reactions (6.2)]. Seizure disorder. (4) Current or prior diagnosis of bulimia or anorexia nervosa. (4) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. (4) Use with an MAOI or within 14 days of stopping treatment with AUVELITY. Do not use AUVELITY within 14 days of discontinuing an MAOI. (4) Known hypersensitivity to bupropion, dextromethorphan, or other components of AUVELITY. (4)

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. Read the full label on DailyMed →

Dextromethorphan hydrobromide, bupropion hydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Human Experience There is limited clinical study experience regarding human overdosage with AUVELITY. Overdosage information is based on experience with the individual components, dextromethorphan and bupropion. Metabolism of the dextromethorphan component of AUVELITY is inhibited by the bupropion component, such that overdose due to AUVELITY might be more severe or more persistent compared to overdose of dextromethorphan alone.

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Dextromethorphan Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis. Other adverse effects include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes. Dextromethorphan may cause serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants. Bupropion Overdoses of up to 30 grams or more of bupropion (approximately 143 times the maximum recommended dose of AUVELITY) have been reported. Seizure was reported in approximately one-third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias, clonus, myoclonus, and hyperreflexia. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients. Overdosage Management Treatment of dextromethorphan overdosage should be directed at symptomatic and supportive measures. There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended. Consider contacting a Poison Help Line (1-800-222-1222) or a medical toxicologist for overdosage management recommendations for AUVELITY.

— FDA label: Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

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• Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide18 products
• Promethazine hydrochloride and dextromethorphan hydrobromidePromethazine Dm · 18 products
• Dextromethorphan hydrobromide and quinidine sulfateNuedexta · 6 products
• Naltrexone hydrochloride and bupropion hydrochlorideContrave Extended-Release · 1 product

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Axsome Therapeutics, Inc.2 products

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

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Recalls

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Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Auvelity, Axsome Therapeutics, Inc., effective August 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

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