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Nuedexta

Last reviewed on RxList: 5/9/2017
Nuedexta Side Effects Center

Last reviewed on RxList 02/14/2017

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) Capsules is a central nervous system (CNS) agent used to treat involuntary outbursts of crying or laughing in people with certain neurological disorders. Common side effects of Nuedexta include:

  • diarrhea,
  • gas,
  • stomach pain,
  • muscle spasm,
  • dizziness,
  • weakness,
  • cough,
  • swelling of your hands or feet and ankles,
  • drowsiness,
  • vomiting,
  • urinary tract infection,
  • feeling like you have the flu, and
  • abnormal liver tests.

Tell your doctor if you have serious side effects of Nuedexta including:

  • easy bruising or bleeding,
  • dark urine,
  • signs of infection (such as fever, persistent sore throat),
  • yellowing eyes or skin, or
  • lupus-like symptoms (joint or muscle pain, chest pain).

The recommended dose of Nuedexta is one capsule a day for 7 days, and 2 capsules a day after that. Nuedexta may interact with grapefruit and grapefruit juice, cough or cold medications that contain dextromethorphan, aprepitant, cimetidine, digoxin, narcotic cough or pain medicines, ADHD medications, antidepressants, antibiotics, antifungals, cancer medicines, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use. Tell your doctor all medications you take. Before taking Nuedexta tell your doctor if you have slow heartbeats or any other type of heart rhythm disorder, an electrolyte imbalance, bladder or bowel obstruction, myasthenia gravis, or a family history of long QT syndrome. If you are pregnant only take Nuedexta if the potential benefit outweighs the potential risk to the fetus. Exercise caution when taking Nuedexta while breastfeeding.

Our Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nuedexta Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using dextromethorphan and quinidine and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pain or burning when you urinate;
  • fever, chills, flu symptoms, nausea, vomiting, feeling light-headed;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions).

Less serious side effects may include:

  • diarrhea, gas, mild stomach pain;
  • muscle spasm;
  • dizziness, weakness;
  • cough; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules)

Nuedexta Professional Information

SIDE EFFECTS

A total of 946 patients participated in four Phase 3 controlled and uncontrolled PBA studies and received at least one dose of the combination product of dextromethorphan/quinidine in various strengths at the recommended or higher than the recommended dose. Of those patients, 393 patients were exposed for at least 180 days and 294 patients were exposed for at least one year. Median exposure was 168 days.

Controlled trials enrolled only patients with either ALS or MS. Uncontrolled studies enrolled 136 patients with PBA secondary to a wide variety of underlying neurological conditions including stroke (45 patients) and traumatic brain injury (23 patients). Consequently, patients with other underlying neurologic diseases may experience other adverse reactions not described below.

Clinical Trials Experience

A 12-week, placebo-controlled study evaluated NUEDEXTA (dextromethorphan 20 mg/quinidine 10 mg) (N=107) and a 30 mg dextromethorphan/10 mg quinidine combination (N=110) compared to placebo (N=109). Approximately 60% of patients had ALS and 40% had MS. Patients were 25 to 80 years of age, with a mean age of approximately 51 years. Three (3) ALS patients in each drug treatment arm and 1 ALS patient in the placebo arm died during the 12-week placebo-control period. All deaths were consistent with the natural progression of ALS.

Adverse Reactions Leading To Discontinuation

The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) that led to discontinuation with the 20 mg dextromethorphan/10 mg quinidine twice daily dose were muscle spasticity (3%), respiratory failure (1%), abdominal pain (2%), asthenia (2%), dizziness (2%), fall (1%), and muscle spasms (2%).

Most Common Adverse Reactions

Adverse drug reactions that occurred in ≥ 3% of patients receiving the 20 mg dextromethorphan/10 mg quinidine twice daily dose, and at an incidence of ≥ 2 times placebo in short-term clinical trials in ALS and MS are provided in Table 1.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Table 1: Adverse Drug Reactions with an Incidence of ≥ 3% of Patients and ≥ 2x Placebo in NUEDEXTA-treated Patients by System-Organ Class and Preferred Term

  NUEDEXTA
N=107
%
Placebo
N=109
%
Diarrhea 13 6
Dizziness 10 5
Cough 5 2
Vomiting 5 1
Asthenia 5 2
Peripheral edema 5 1
Urinary tract infection 4 1
Influenza 4 1
Increased gamma-
glutamyltransferase 3 0
Flatulence 3 1

Long-Term Exposure With NUEDEXTA

The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials.

Safety Experience Of Individual Components

The following adverse reactions have been reported with the use of the individual components of NUEDEXTA, dextromethorphan and quinidine, from post-marketing experience. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dextromethorphan

Drowsiness, dizziness, nervousness or restlessness, nausea, vomiting, and stomach pain.

Quinidine

Cinchonism is most often a sign of chronic quinidine toxicity, but it may appear in sensitive patients after a single moderate dose of several hundred milligrams. Cinchonism is characterized by nausea, vomiting, diarrhea, headache, tinnitus, hearing loss, vertigo, blurred vision, diplopia, photophobia, confusion, and delirium.

Convulsions, apprehension, and ataxia have been reported with quinidine therapy, but it is not clear that these were not simply the results of hypotension and consequent cerebral hypoperfusion in patients being treated for cardiovascular indications. Acute psychotic reactions have been reported to follow the first dose of quinidine, but these reactions appear to be extremely rare. Other adverse reactions occasionally reported with quinidine therapy include depression, mydriasis, disturbed color perception, night blindness, scotomata, optic neuritis, visual field loss, photosensitivity, keratopathy, and abnormalities of skin pigmentation.

Read the entire FDA prescribing information for Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules)

Related Resources for Nuedexta

Read the Nuedexta User Reviews »

© Nuedexta Patient Information is supplied by Cerner Multum, Inc. and Nuedexta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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