Safety

NUEDEXTA has a
demonstrated safety
profile

Adverse events were generally mild to moderate and consistent across studies1,2

Adverse reactions with NUEDEXTA1

STAR TRIAL
Adverse reaction with an incidence of ≥3% and ≥2x placebo in NUEDEXTA-treated patients by system organ class and preferred term.2
These are not all the risks from use of NUEDEXTA.2
Table representing adverse reactions with NUEDEXTA vs placebo in the Star trial Table representing adverse reactions with NUEDEXTA vs placebo in the Star trial Adverse reaction Diarrhea Dizziness Cough Vomiting Asthenia Peripheral edema Urinary tract infection Influenza Increased gamma-glutamyltransferase Flatulence dextromethorphan 20 mg quinidine 10 mg (n=107) NUEDEXTA 13% 10% 5% 5% 5% 5% 4% 4% 3% 3% Placebo (n=109) 6% 5% 2% 1% 2% 1% 1% 1% 0% 1%
Table representing adverse reactions with NUEDEXTA vs placebo in the Star trial Table representing adverse reactions with NUEDEXTA vs placebo in the Star trial Adverse reaction Diarrhea Dizziness Cough Vomiting Asthenia Peripheral edema Urinary tract infection Influenza Increased gamma-glutamyltransferase Flatulence NUEDEXTA dextromethorphan 20 mg 
quinidine 10 mg (n=107) 13% 10% 5% 5% 5% 5% 4% 4% 3% 3% Placebo 
(n=109) 6% 5% 2% 1% 2% 1% 1% 1% 0% 1%

Adverse events were generally mild to moderate and consistent across studies.1

Study design: The pivotal trial was a 12-week, randomized, placebo-controlled study of 326 patients with amyotrophic lateral sclerosis (n=197) or multiple sclerosis (n=129) and clinically significant Pseudobulbar Affect (PBA). Patients received NUEDEXTA dextromethorphan 20 mg/quinidine 10 mg (n=107), placebo (n=109), or dextromethorphan 30 mg/quinidine 10 mg (unapproved dose [n=110]) twice daily (once daily in week 1). The baseline daily PBA episode rates were 6.8 in the NUEDEXTA dextromethorphan 20 mg/quinidine 10 mg group and 4.5 in the placebo group.2,3

PRISM II open-label study1

Reported adverse events were generally consistent with the NUEDEXTA safety profile observed in the placebo-controlled pivotal trial.1

Table representing adverse reactions in the Prism II Open-Label Study Table representing adverse reactions in the Prism II Open-Label Study Adverse events (N=367)* Diarrhea Headache Urinary tract infection Dizziness Nausea Fall Fatigue Somnolence Dry mouth Gastroesophageal reflux disease Agitation Peripheral edema n (%) 20 (5.4) 15 (4.1) 10 (2.7) 9 (2.5) 6 (1.6) 6 (1.6) 5 (1.4) 5 (1.4) 4 (1.1) 4 (1.1) 4 (1.1) 4 (1.1)
Table representing adverse reactions in the Prism II Open-Label Study Table representing adverse reactions in the Prism II Open-Label Study Adverse events (N=367)* Diarrhea Headache Urinary tract infection Dizziness Nausea Fall Fatigue Somnolence Dry mouth Gastroesophageal reflux disease Agitation Peripheral edema n (%) 20 (5.4) 15 (4.1) 10 (2.7) 9 (2.5) 6 (1.6) 6 (1.6) 5 (1.4) 5 (1.4) 4 (1.1) 4 (1.1) 4 (1.1) 4 (1.1)

*Adverse events occurring in more than 1% of patients

Study design: A 90-day, open-label trial of 367 patients with stroke, dementia, or traumatic brain injury. Patients received 1 capsule of NUEDEXTA per day during week 1 and were titrated to 1 capsule twice a day for week 2 through day 90.1

Drug interactions for NUEDEXTA

When prescribing NUEDEXTA for patients with PBA, keep in mind that it should not be taken with monoamine oxidase inhibitors (MAOIs) or by patients who have taken MAOIs in the last 14 days. While NUEDEXTA may be taken with some selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, it increases the risk for serotonin syndrome. For dosing precautions for the SSRI paroxetine and the tricyclic antidepressant desipramine, review Section 12 of the Full Prescribing Information linked below.1

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NUEDEXTA is not an antipsychotic medication or a controlled substance.2,4

These are not all the possible risks, drug interactions, or side effects associated with NUEDEXTA. Explore more here:

Important Safety Information Full Prescribing Information

NUEDEXTA contains an ultralow dose of quinidine2,3

The daily quinidine dose (20 mg daily, 10 mg q12h) in NUEDEXTA is approximately 3% of the lowest recommended antiarrhythmic dose.5

QUINIDINE DAILY DOSAGE2,5

Graph showing levels of quinidine daily dosage. High antiarrhythmic appears at 
1600 mg, Low antiarrhythmic appears at 600 mg, NUEDEXTA appears at 20 mg

Cardiovascular contraindication

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 (eg, thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or those at high risk of complete AV block.2

Learn about dosing guidelines for NUEDEXTA on our Dosing & treatment page.

q12h=every 12 hours.

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  • References: 1.

    Hammond FM, Alexander DN, Cutler AJ, et al. PRISM II: an open-label study to assess effectiveness of dextromethorphan/‌quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury. BMC Neurol. 2016;16:89. doi:10.1186/‌s12883-016-0609-0

  • 2.

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

  • 3.

    Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68(5):693-702. doi:10.1002/‌ana.22093

  • 4.

    Drug Enforcement Administration. Controlled substances. Diversion Control Division. Accessed June 10, 2024. https://www.deadiversion.usdoj.gov/‌schedules/‌orangebook/‌c_cs_alpha.pdf

  • 5.

    Grace AA, Camm AJ. Quinidine. N Engl J Med. 1998;338:35-45. doi:10.1056/‌NEJM199801013380107

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

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.