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NUEDEXTA:

The first FDA-approved treatment proven to reduce PBA episodes1

Pseudobulbar Affect (PBA) is a neurologic condition characterized by sudden, frequent, and uncontrollable crying and/or laughing, and it can be mistaken for depression. Clinically proven NUEDEXTA is a medication for Pseudobulbar Affect that can make a difference1-3

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NUEDEXTA®
has been a recognized name in the treatment of PBA since 20114

Prescribed by more than 80,000 doctors to over 200,000 patients5

  • References: 1.

    Nuedexta. Package insert. Otsuka America Pharmaceutical, Inc.; 2022.

  • 2.

    Brooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE. PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS One. 2013;8(8):e72232. doi:10.1371/journal.pone.0072232

  • 3.

    Miller A, Pratt H, Schiffer RB. Pseudobulbar affect: the spectrum of clinical presentations, etiologies and treatments. Expert Rev Neurother. 2011;11(7):1077-1088. doi:10.1586/ern.11.68

  • 4.

    AVANIR Pharmaceuticals Announces U.S. Launch and Availability of NUEDEXTATM for Pseudobulbar Affect. Accessed on January 14, 2026. https://www.prnewswire.com/news-releases/avanir-pharmaceuticals-announces-us-launch-and-availability-of-nuedexta-for-pseudobulbar-affect-114928789.html

  • 5.

    Data on file. IQVIA LAAD. Otsuka America Pharmaceutical, Inc. 2025.

  • 6.

    Suavé WM. Recognizing and treating pseudobulbar affect. CNS Spectr. 2016;21(S1):34-44. doi:10.1017/S1092852916000791

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~37%* of your patients with a primary neurologic condition  
may be suffering from PBA2

46%*

OF PATIENTS WITH MULTIPLE SCLEROSIS2

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52%*

OF PATIENTS WITH TRAUMATIC BRAIN INJURY2

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29%*

OF PATIENTS WITH ALZHEIMER DISEASE2

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PBA also affects many patients with stroke, amyotrophic lateral sclerosis, and Parkinson’s disease. PBA is not limited to
these underlying conditions.2

*Based on the PRISM Registry including 5290 patients with stroke, amyotrophic lateral sclerosis, multiple sclerosis, traumatic brain injury, Alzheimer disease, and Parkinson’s disease. Patients with PBA symptoms were defined as having a CNS-LS score of ≥13.2

CNS-LS=Center for Neurologic Study-Lability Scale.

Consider NUEDEXTA: a medication proven to reduce Pseudobulbar Affect (PBA) episodes1

NUEDEXTA is a combination of dextromethorphan HBr (20 mg) and quinidine sulfate (10 mg) in a capsule.1

Explore NUEDEXTA Efficacy
Impact of PBA Impact of PBA

Impact of PBA: suffering in silence

PBA episodes can cause immense distress, embarrassment, and confusion for patients.3,6

REVEAL THE IMPACT

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Three circles with three steps: 1 - Ask 2 - Differentiate 3 - Document

The key to diagnosing PBA

Learn 3 steps to help you assess patients for PBA.

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Two NUEDEXTA capsules
Follow the recommended dosing schedule1

After starting with one tablet a day for 7 days, NUEDEXTA is dosed twice daily, starting on day 8.1 Help your patients understand the importance of following the recommended dosing schedule.

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IMPORTANT SAFETY INFORMATION and INDICATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)INDICATION and IMPORTANT SAFETY INFORMATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Quinidine and Related Drugs: NUEDEXTA contains quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.
  • Hypersensitivity: NUEDEXTA is contraindicated in patients with a history of NUEDEXTA-, quinine-, mefloquine-, or quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, lupus-like syndrome, or known hypersensitivity to dextromethorphan (e.g., rash, hives).
  • MAOIs: NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
  • Cardiovascular: NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

Thrombocytopenia and Other Hypersensitivity Reactions: Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs.

Hepatotoxicity: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue immediately if this occurs.

Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. QT prolongation can cause torsades de pointes–type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3 to 4 hours after the first dose. Some risk factors include use with CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities, bradycardia, or left ventricular hypertrophy or dysfunction. If patients taking NUEDEXTA experience symptoms that could indicate the occurrence of cardiac arrhythmias (e.g., syncope or palpitations), NUEDEXTA should be discontinued, and the patient further evaluated.

Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits CYP2D6 and may interact with other drugs metabolized by CYP2D6. Adjust dose of CYP2D6 substrates as needed.

Dizziness: NUEDEXTA may cause dizziness. Take precautions to reduce the risk of falls.

Serotonin Syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of “serotonin syndrome.”

Anticholinergic Effects of Quinidine: Monitor for worsening in myasthenia gravis.

Adverse Reactions: The most common adverse reactions (incidence of ≥3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks for use of NUEDEXTA.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

Please see FULL PRESCRIBING INFORMATION.