FDA-filed SPL labeling · retrieved through openFDA

Dextromethorphan and Quinidine

Dextromethorphan and quinidine is a prescription combination used to treat pseudobulbar affect (PBA) — uncontrolled, involuntary episodes of laughing or crying caused by a neurological condition.

Brand names NuedextaDextromethorphan hydrobromide and quinidine sulfateDextromethorphan Hydrobromide and Quinidine Sulphate
Drug classes Antiarrhythmic
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 21, 2025
Clinical labels in scope 5
AvailabilityRx
Earliest approval/marketing year 2010
FDA-listed product records 10
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Dextromethorphan and Quinidine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dextromethorphan and quinidine (Nuedexta) is the only FDA-approved treatment specifically for pseudobulbar affect (PBA), a neurological condition that causes uncontrollable laughing or crying. It works by combining an active brain-acting ingredient (dextromethorphan) with a booster (quinidine) to keep drug levels effective. It comes with important warnings around heart rhythm, bleeding risk, and drug interactions, so it's important to review your full medication list with your prescriber before starting.

📖 Dextromethorphan and Quinidine: Patient Information Guide

A plain-language walkthrough of Dextromethorphan and Quinidine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Dextromethorphan and quinidine is a combination oral capsule indicated for one specific condition across all supported products.

  • Pseudobulbar affect (PBA): Nuedexta, Dextromethorphan hydrobromide and quinidine sulfate capsules, and Dextromethorphan Hydrobromide and Quinidine Sulphate capsules are all approved to treat PBA — a neurological condition marked by involuntary, sudden, and frequent episodes of laughing and/or crying that do not match a person's actual emotional state. PBA occurs as a secondary condition to underlying neurological diseases such as ALS or MS, among others, and is distinct from general emotional instability tied to neurological illness.
⚙️How it works

Dextromethorphan is the therapeutically active ingredient: it blocks NMDA receptors (a type of brain signaling receptor) and activates sigma-1 receptors, both of which are thought to play a role in PBA — though the exact mechanism isn't fully understood. Quinidine's job in this combination is purely pharmacological: it inhibits the liver enzyme CYP2D6, which would otherwise break dextromethorphan down too quickly. By slowing that breakdown, quinidine allows dextromethorphan to reach and maintain the blood levels needed for a therapeutic effect — something that couldn't be achieved with dextromethorphan alone at safe doses.

💊How it's taken

All capsule forms of dextromethorphan and quinidine are taken by mouth. The starting dose is one capsule once daily for the first 7 days; from day 8 onward, the maintenance dose is one capsule every 12 hours (twice a day). The capsules can be taken with or without food. Your prescriber will reassess periodically whether continued treatment is still needed, since PBA sometimes improves on its own over time.

🤒Side effects — in detail

The most common side effects reported in clinical trials include:

  • Diarrhea
  • Dizziness
  • Cough
  • Vomiting
  • Weakness or fatigue (asthenia)
  • Swelling in the legs or feet (peripheral edema)
  • Urinary tract infection
  • Flu-like symptoms (influenza)
  • Elevated liver enzyme (gamma-glutamyltransferase)
  • Gas (flatulence)

Serious reactions — including dangerous drops in platelet count (thrombocytopenia), liver inflammation (hepatitis), heart rhythm problems, and serotonin syndrome — require prompt medical attention. Stop the medication and call your doctor right away if you notice unusual bleeding, jaundice, fainting, irregular heartbeat, or symptoms like agitation, fever, or muscle twitching.

⚠️Warnings & precautions
  • Thrombocytopenia (dangerous drop in platelets): Quinidine can trigger an immune response that destroys platelets, potentially leading to severe or fatal bleeding. Stop the medication immediately if this occurs and do not restart it. Cross-sensitivity with quinine and mefloquine is possible.
  • Hepatitis: Liver inflammation has been reported, usually in the first few weeks. Fever and thrombocytopenia may also be present. Most cases resolve when the medication is stopped.
  • QT prolongation and heart rhythm risk: This medication can prolong the QT interval in a dose-dependent way, raising the risk of a dangerous arrhythmia called torsades de pointes. An ECG should be done at baseline and 3–4 hours after the first dose in patients at elevated risk, including those taking QT-prolonging drugs or CYP3A4 inhibitors, or those with left ventricular hypertrophy or dysfunction. Correct low potassium or magnesium before starting.
  • Serotonin syndrome: When combined with SSRIs or tricyclic antidepressants, there is a risk of serotonin syndrome — a potentially serious condition involving agitation, rapid heartbeat, high temperature, and muscle twitching. Seek immediate care if symptoms appear.
  • Dizziness and fall risk: About 10% of patients in controlled trials experienced dizziness. Take precautions, especially if you already have difficulty with balance or walking.
  • CYP2D6 drug interactions: Quinidine inhibits the CYP2D6 enzyme, which processes many other medications. This can cause other drugs to build up to higher-than-expected levels or prevent prodrugs (like codeine) from being activated. Review all medications with your prescriber.
🔀What it interacts with

This medication has several important drug interactions, mainly because quinidine blocks the CYP2D6 liver enzyme and affects heart rhythm:

  • MAOIs: Absolutely contraindicated — combining these can cause serious or fatal serotonin syndrome. Wait at least 14 days after stopping an MAOI before starting, and at least 14 days after stopping this medication before starting an MAOI.
  • Thioridazine or pimozide: Contraindicated — these drugs both prolong QT and are processed by CYP2D6, creating a compounded risk of dangerous heart arrhythmia.
  • SSRIs (e.g., fluoxetine) and tricyclic antidepressants: Increase the risk of serotonin syndrome; use with caution and monitor closely.
  • Desipramine: Levels can rise approximately 8-fold — dose reduction is required if used together.
  • Paroxetine: Levels can roughly double — consider starting at a lower dose and monitor.
  • Digoxin: Levels can nearly double because quinidine inhibits P-glycoprotein; monitor digoxin levels closely and reduce the dose as needed.
  • Other quinidine, quinine, or mefloquine products: Must not be combined with this medication.
  • CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, grapefruit juice): Can increase quinidine levels and QT-prolongation risk; an ECG may be needed.
  • Alcohol and CNS depressants: Use with caution — additive effects on the central nervous system are possible.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take if you have a prolonged QT interval, congenital long QT syndrome, a history suggesting torsades de pointes, or heart failure — these are contraindications.
  • Do not take if you have complete heart block (AV block) without a pacemaker, or if you are at high risk of developing complete AV block.
  • Do not take if you have had an immune reaction (such as thrombocytopenia, hepatitis, bone marrow suppression, or a lupus-like reaction) to quinidine, quinine, or mefloquine.
  • Do not take if you have a known allergy to dextromethorphan (e.g., rash or hives).
  • Do not use with MAOIs or within 14 days of stopping one.
  • Pregnancy: Animal studies showed developmental harm including birth defects and embryo loss. There are no adequate human studies. Discuss the risks with your doctor.
  • Breastfeeding: Quinidine passes into breast milk. The effect on nursing infants is not fully known. Talk to your doctor about the benefits and risks.
  • Children: Safety and effectiveness in patients under 18 have not been established.
  • Older adults: Use with caution; dose selection should be conservative, given the higher likelihood of reduced kidney, liver, or heart function and multiple medications.
  • Kidney or liver impairment: Dose adjustment is not required for mild-to-moderate impairment, but caution is warranted — drug levels may increase significantly in severe impairment.
  • If you are a CYP2D6 poor metabolizer (your body naturally can't process this enzyme well), talk to your doctor — quinidine's main benefit may not apply to you, but its risks still do.
🚑If you take too much

An overdose of dextromethorphan and quinidine can cause symptoms including nausea, dizziness, vomiting, confusion, blurred vision, hearing changes, and — most seriously — dangerous heart rhythm problems (including torsades de pointes) and low blood pressure from the quinidine component, as well as seizures, respiratory depression, or stupor from excess dextromethorphan. Because quinidine slows the breakdown of dextromethorphan, overdose effects may be more severe or last longer than with dextromethorphan alone. Seek emergency medical care immediately if an overdose is suspected.

📡Pharmacodynamics — effects in the body

This medication causes a measurable, dose-dependent prolongation of the QTc interval — an electrical marker of how long it takes the heart to recharge between beats. At the recommended dose, the average QTc increase is modest (around 6–7 milliseconds), but at higher-than-recommended doses, the increase is larger. QT prolongation raises the risk of a specific type of dangerous heart arrhythmia called torsades de pointes, and this risk grows as the degree of QT lengthening increases. This effect is why the medication carries important heart-related contraindications and monitoring requirements.

🔬Pharmacokinetics — how your body processes it

After taking the capsule, dextromethorphan reaches peak blood levels in approximately 3 to 4 hours, and quinidine peaks in about 1 to 2 hours. Because quinidine blocks the CYP2D6 enzyme that would otherwise break down dextromethorphan rapidly, taking both together results in roughly 20 times more dextromethorphan in the bloodstream than dextromethorphan taken alone. Dextromethorphan has an elimination half-life of approximately 13 hours (the time it takes for blood levels to fall by half), while quinidine's half-life is approximately 7 hours. Both ingredients are processed primarily by the liver, and food does not significantly affect how much of either is absorbed, so the capsules can be taken with or without meals.

📦How to store it

Store dextromethorphan hydrobromide and quinidine sulfate capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from light and moisture.

📄 Written from Dextromethorphan and Quinidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dextromethorphan and Quinidine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is pseudobulbar affect, and is this medication just for that?
Yes — this medication is specifically approved just for pseudobulbar affect, or PBA. PBA is a condition where you laugh or cry suddenly, involuntarily, and often much more intensely than how you actually feel inside. It's not a mood disorder — it's caused by neurological damage or disease (like ALS or MS) that disrupts how the brain controls emotional expression. It can be embarrassing and exhausting, but it is treatable, and that's exactly what this medication targets.
How long does it take to start working, and do I need to take it forever?
You'll start at one capsule a day for the first week, then move to one capsule every 12 hours after that. Some people notice an improvement within weeks of reaching the full dose, but everyone's response is a little different. This isn't necessarily a lifelong medication — your doctor will check in regularly to see if you still need it, since PBA can sometimes improve on its own over time.
I take an antidepressant. Is that a problem?
It can be, depending on which one. SSRIs like fluoxetine and tricyclic antidepressants like clomipramine can interact with this medication and raise the risk of a condition called serotonin syndrome — where too much serotonin builds up in the brain, causing agitation, rapid heartbeat, muscle twitching, and high temperature. Make sure your prescriber knows every medication you take. Some combinations may still be used carefully with monitoring, but others may need to be adjusted.
What side effects should I actually expect, and when should I be worried?
The most common ones are diarrhea, dizziness, cough, and vomiting — most people who get side effects find them mild and manageable. Dizziness is worth taking seriously if you have any trouble walking or a history of falls — take it slowly when standing up. You should call your doctor right away if you notice unusual bruising or bleeding, yellowing of your skin or eyes, fainting, or irregular heartbeat. These could signal rare but serious reactions involving your blood, liver, or heart rhythm.
Can I drink alcohol while taking this medication?
It's best to be cautious. This medication acts on the brain and central nervous system, and combining it with alcohol can increase the effects of both — leading to more dizziness, sedation, or impaired coordination. There's no hard 'never drink a drop' rule in the label, but your safest bet is to talk to your pharmacist or doctor about your specific situation before drinking.
Is this medication safe during pregnancy or if I'm breastfeeding?
This is an important conversation to have with your doctor. Animal studies showed this medication can cause birth defects and pregnancy loss, so there's real concern about its safety during pregnancy — though there aren't definitive human studies yet. Quinidine does pass into breast milk, and the effect on nursing babies isn't fully known. Your doctor will weigh the risks against the benefits of treating your PBA and help you make the best decision for you and your baby.
Is Dextromethorphan and Quinidine available over the counter?
Dextromethorphan and Quinidine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dextromethorphan and Quinidine first available?
Dextromethorphan and Quinidine has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dextromethorphan and Quinidine?
Dextromethorphan and Quinidine is supplied by 7 manufacturers listed in the FDA NDC Directory, including Avanir Pharmaceuticals, Inc., Otsuka America Pharmaceutical, Inc, Camber Pharmaceuticals, Inc..

💬 Answers drafted from Dextromethorphan and Quinidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Dextromethorphan and Quinidine comes

Dextromethorphan and Quinidine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Dextromethorphan hydrobromide and quinidine sulfate Dextromethorphan Hydrobromide and Quinidine Sulphate Nuedexta
How this form is used
What it may be used for
  • Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA)
  • Dextromethorphan Hydrobromide and Quinidine Sulphate capsules are indicated for the treatment of pseudobulbar affect (PBA)
  • Nuedexta is indicated for the treatment of pseudobulbar affect (PBA)
Important instructions
  • Nuedexta, Dextromethorphan hydrobromide and quinidine sulfate, and Dextromethorphan Hydrobromide and Quinidine Sulphate capsules are all taken by mouth: one capsule once daily for the first 7 days, then one capsule every 12 hours (twice daily) from day 8 onward
  • All capsule forms may be taken with or without food — food does not significantly affect how the medication is absorbed
  • Your doctor will periodically reassess whether continued treatment is needed, as PBA can improve on its own in some patients
Available strengths 1 strength
10 FDA-listed product records

📊 Dextromethorphan and Quinidine across the U.S. market

How Dextromethorphan and Quinidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
7
Manufacturers
3
Brand names
10
FDA-listed product records
2010
First marketed
Avanir Pharmaceuticals, Inc.30%
Otsuka America Pharmaceutical, Inc20%
Camber Pharmaceuticals, Inc.10%
Patheon Inc.10%
Sun Pharmaceutical Industries, Inc.10%
Golden State Medical Supply, Inc.10%
Other makers10%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Dextromethorphan and Quinidine is used

A general measure of how commonly Dextromethorphan and Quinidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dextromethorphan and Quinidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

22,121
Medicaid prescriptions filled (Q1–Q4 2025)
$28.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dextromethorphan and Quinidine prescribed? Of the 1,596 medications we measure, Dextromethorphan and Quinidine ranks #781 by Medicaid prescriptions — more than 51% of them.

Where Dextromethorphan and Quinidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Dextromethorphan and Quinidine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule

22,121 Medicaid prescriptions (Q1–Q4 2025) 100% of Dextromethorphan and Quinidine prescriptions shown $28.6M gross reimbursement (before rebates) ≈ $1,295 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1040054

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dextromethorphan and Quinidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 7 listed Dextromethorphan and Quinidine NDCs with Medicaid activity.

🔍 Compare Dextromethorphan and Quinidine products

A representative set of FDA-listed product records for Dextromethorphan and Quinidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Capsule
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Avanir Pharmaceuticals, Inc. NDA View NDC →
20; 10 mg/1; mg Oral Avanir Pharmaceuticals, Inc. × 2 listings NDA View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Golden State Medical Supply, Inc. ANDA View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Otsuka America Pharmaceutical, Inc NDA View NDC →
20; 10 mg/1; mg Oral Otsuka America Pharmaceutical, Inc NDA View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Patheon Inc. DRUG FOR FURTHER PROCESSING View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Sun Pharmaceutical Industries, Inc. ANDA View NDC →
DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; QUINIDINE SULFATE 10 mg Oral Teva Pharmaceuticals, Inc. ANDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Dextromethorphan and Quinidine NDCs →

🏷️ Sold under these brand names

Nuedexta Dextromethorphan hydrobromide and quinidine sulfate Dextromethorphan Hydrobromide and Quinidine Sulphate

🏭 Manufacturers & labelers

Avanir Pharmaceuticals, Inc. 3 Otsuka America Pharmaceutical, Inc 2 Camber Pharmaceuticals, Inc. 1 Patheon Inc. 1 Sun Pharmaceutical Industries, Inc. 1 Golden State Medical Supply, Inc. 1 Teva Pharmaceuticals, Inc. 1

RxNorm drug class

Dextromethorphan and Quinidine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 21, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dextromethorphan and Quinidine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dextromethorphan and Quinidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
NDC products indexed
10
Distinct labelers/manufacturers represented
7
Linked representative label
Avanir Pharmaceuticals, Inc.
Linked label effective
Oct 21, 2025
Composite sections available
22
Linked SPL Set ID
484e0918-3442-49dc-8ccf-177f1f3ee9f3
Linked SPL Document ID
545d121c-01b2-4375-9067-52fc8ad23d74
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Avanir Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.