Nuplazid (Pimavanserin) – Oral

Warning:

The Food and Drug Administration (FDA) has issued a black box warning (its strictest warning) of a higher chance of death with Nuplazid use in older adults with dementia-related psychosis. Nuplazid is not FDA approved for dementia-related psychosis that is unrelated to Parkinson's disease psychosis.

What Is Nuplazid?

Nuplazid (pimavanserin) is a treatment option for hallucinations and delusions related to psychosis due to Parkinson's disease. Nuplazid is an atypical antipsychotic, which is also known as a second-generation antipsychotic.

Nuplazid attaches to the 5-HT2A and 5-HT2C receptors (binding sites). By attaching to these receptors, Nuplazid is thought to affect how certain brain chemicals work.

Nuplazid is available as prescription tablets and capsules. Nuplazid carries a black box warning of a higher chance of death with Nuplazid use in older adults with dementia-related psychosis. Nuplazid is not approved by the FDA for dementia-related psychosis that is unrelated to Parkinson's disease psychosis.

Drug Facts

Generic Name: Pimavanserin

Brand Name(s): Nuplazid

Drug Availability: Prescription

Therapeutic Classification: Atypical antipsychotic

Available Generically: No

Controlled Substance: N/A

Administration Route: Oral (by mouth)

Active Ingredient: Pimavanserin

Dosage Form(s): Tablets and capsules

What Is Nuplazid Used For?

Nuplazid is a medication option to treat hallucinations and delusions related to Parkinson's disease psychosis. Hallucinations are symptoms of hearing or seeing things that aren't there. Delusions are false beliefs.

Approximately 1 million people live with Parkinson's disease (PD) in the United States, and an estimated 50,000 people receive a PD diagnosis every year. Roughly 50% of people with PD may experience hallucinations or delusions.

How to Take Nuplazid

Take Nuplazid by mouth once daily with or without food.

If you have trouble swallowing pills, consider taking a capsule. You can gently pull the capsule apart and sprinkle its contents on 1 tablespoon of soft food. Examples of soft food include:

  • Applesauce
  • Pudding
  • Yogurt
  • Liquid nutritional supplement

After you sprinkle the capsule contents in one of these soft food options, take the mixture right away. Don't save it for future use.

Storage

After you pick up Nuplazid from the pharmacy, store the medication at room temperature, between 68 degrees to 77 degrees Fahrenheit (F). It's permitted to take Nuplazid with you on brief excursions in temperatures ranging from 59 degrees to 86 degrees F. Protect capsules from light to prevent color fading.

To be safe, place Nuplazid in a locked cabinet or closet to keep your medications out of the reach of children and pets.

If you plan to travel with Nuplazid, become familiar with your final destination's regulations. In general, be sure to make a copy of your Nuplazid prescription.

If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

Visit the FDA website to know where and how to discard of all unused and expired drugs. You can also locate disposal boxes in your area. If you have any questions about the best ways to dispose of your medications, ask your pharmacist or healthcare provider.

How Long Does Nuplazid Take to Work?

You might start noticing some improvement in your symptoms within two weeks. Nuplazid, however, might take a couple of months to become fully effective.

Off-Label Uses

Nuplazid doesn't have any off-label uses.

What Are the Side Effects of Nuplazid?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

A common side effect of Nuplazid is edema (swelling from fluid buildup) in your arms, hands, legs, or feet. Some people might also experience confusion.

Severe Side Effects

Serious side effects and their symptoms include:

  • Severe allergic reaction: Symptoms may include breathing difficulties, swelling, and hives.
  • Abnormal heart rhythm: Symptoms may include fast heart rate, dizziness, and feeling faint.
  • Death: There is a higher risk of death with Nuplazid use in older adults with dementia-related psychosis.

Contact your healthcare provider right away if you develop severe side effects. Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

There are no reports of risks with taking Nuplazid long term.

Report Side Effects

Nuplazid may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Nuplazid Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules, tablets):
    • For treatment of hallucinations and delusions:
      • Adults—34 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Nuplazid:

Severe allergic reaction: If you have a severe allergic reaction to Nuplazid or any of its ingredients, your healthcare provider will not recommend this drug to you.

High risk of abnormal heart rhythm: If you have an increased risk of an abnormal heart rhythm, your healthcare provider might avoid recommending Nuplazid. Some risk factors may include your medications—like heart rhythm medications (e.g., amiodarone, sold under the brand names Cordarone and Pacerone)—and medical conditions (e.g., history of abnormal heart rhythm).

Pregnancy: Animal studies suggest that Nuplazid is linked to adverse (negative) effects on the fetus. Not enough is known about about the safety and effectiveness of Nuplazid in pregnant humans. Let your healthcare provider know if you are or plan to become pregnant. They will help you weigh the benefits and risks of taking Nuplazid during your pregnancy.

Breastfeeding: In animal studies, Nuplazid lead to low birth weight in offspring. However, there is no safety and effectiveness information about Nuplazid in nursing humans. Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Nuplazid while nursing. They will also discuss the different ways available to feed your baby.

Adults over 65 years: There are no safety and effectiveness differences between older and younger adults.

Children: There is limited safety and effectiveness data of Nuplazid in children.

Kidney problems: Individuals with kidney problems may not be able to clear medication from their bodies as easily as people with healthy kidneys. So, the high amounts of Nuplazid in the body increase the likelihood of side effects. For this reason, if you have severe kidney impairment, your healthcare provider will use caution with Nuplazid. They may also closely monitor you for side effects.

Strong CYP3A4-inhibiting medications: CYP3A4 is a protein in the liver responsible for breaking down medications, such as Nuplazid. CYP3A4-inhibiting medications—like the clarithromycin antibiotic—might prevent CYP3A4 from working as well. With a build-up of Nuplazid in the body, there's also a higher chance of side effects. Therefore, your healthcare provider may lower your Nuplazid dose if you're taking potent CYP3A4 inhibitors.

Swallowing difficulties: If you have swallowing difficulties, consider using a capsule. You can gently pull the capsule apart and sprinkle its contents on 1 tablespoon of soft food.

Missed Dose

If you accidentally forgot your Nuplazid dose, take it as soon as you remember. However, if it's already close to your next scheduled dose, skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways to help yourself remember to routinely take your medication. If you miss too many doses, Nuplazid might be less effective.

Overdose: What Happens If I Take Too Much Nuplazid?

The symptoms of a suspected overdose with Nuplazid may include:

  • Abnormal heart rhythm
  • Nausea
  • Vomiting

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Nuplazid?

If you think you or someone else may have overdosed on Nuplazid, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Nuplazid, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Contact your doctor right away if you feel dizzy or faint, or have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Nuplazid?

Before taking Nuplazid, talk with your healthcare provider if any of the following applies to you:

  • Severe allergic reaction: If you have a severe allergic reaction to Nuplazid or its components (ingredients), then Nuplazid isn't a viable option.
  • High risk of abnormal heart rhythm: Certain factors—like your medical conditions—may increase your risk of having an abnormal heart rhythm. For example, Nuplazid isn't recommended for you if you have low potassium, low magnesium, symptoms from a slow heart rate, or a history of an abnormal heart rhythm.
  • Pregnant or nursing parents: There is no safety and effectiveness information about Nuplazid in pregnant or nursing parents. Talk with your healthcare provider to weigh the benefits and risks of taking Nuplazid while pregnant or nursing.
  • Children: There is limited safety and effectiveness data about Nuplazid in children.
  • Odults over 65 years: There are no safety and effectiveness differences for Nuplazid use between older and younger adults.

What Other Medications Interact With Nuplazid?

Use caution when taking Nuplazid with the following medications:

  • Medications that affect heart rhythm: Nuplazid raises the likelihood of an abnormal heart rhythm. Other medications may also increase this risk. Examples include chlorpromazine antipsychotic, moxifloxacin antibiotic, and amiodarone heart rhythm medication. Avoid combining Nuplazid with these medications.
  • Strong CYP3A4-inhibiting medications: CYP3A4-inhibiting medications—like the ketoconazole antifungal—might prevent CYP3A4 from effectively breaking down Nuplazid. As a result, there'll be a buildup of Nuplazid in the body, which increases the likelihood of side effects.
  • Moderate or strong CYP3A4-inducing medications: CYP3A4-inducing medications, on the other hand, encourage CYP3A4 to quickly break down Nuplazid. With low amounts of Nuplazid in the body, it'll be less effective. An example of a CYP3A4-inducing medication includes Dilantin (phenytoin) for seizures.

For more detailed information about medication interactions with Nuplazid, talk with your pharmacist or healthcare provider.

And be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Nuplazid is an atypical, or second-generation, antipsychotic used for hallucinations or delusions related to Parkinson's disease psychosis. Other commonly used atypical antipsychotics for PD psychosis include Clozaril (clozapine) and Seroquel (quetiapine).

Clinical trials suggest that Clozaril may benefit people with PD psychosis without worsening their ability to move. Unlike other antipsychotics, however, Clozaril is part of the FDA's Risk Evaluation and Mitigation Strategies (REMS) program. The REMS is a drug-safety program requiring patients to have frequent monitoring of their white blood cells (WBCs). As a result, Clozaril can be an inconvenient option.

Compared to other antipsychotics, Seroquel carries a lower risk of death for use in older adults with dementia-related psychosis. Also, Seroquel isn't a REMS medication. Clinical studies for Seroquel, however, show conflicting results for PD psychosis. If Seroquel is effective in treating PD psychosis, it might not be as effective as Clozaril.

Like Seroquel, Nuplazid is not a REMS medication. Like Clozaril, clinical trials for Nuplazid are also promising—suggesting a benefit for people with PD psychosis. Nuplazid also doesn't appear to have negative effects on study participants' ability to move.

Unlike Clozaril and Seroquel, Nuplazid isn't available as a generic product. Furthermore, there aren't any recent effectiveness and safety studies that compare Nuplazid to these other antipsychotics.

Since all of these medications are antipsychotics, they're not typically used together. For other mental health conditions—like resistant schizophrenia, however, Clozaril and Seroquel) may be used together.

Frequently Asked Questions

  • Where is Nuplazid available?

    Nuplazid is probably not available at your local retail pharmacy. Your healthcare provider may need to send your Nuplazid prescription to a particular pharmacy, such as a specialty pharmacy.

  • How much does Nuplazid cost?

    Nuplazid doesn't have a generic version yet. Additionally, its distribution might be limited to certain pharmacies, such as specialty pharmacies. As a result, Nuplazid is likely expensive without insurance coverage.

    If cost is a concern, Nuplazid's manufacturer does offer a support program that helps you check on your insurance coverage. The program might also help you save money. For eligibility questions, visit the website of the drug manufacturer, Acadia, or call 844-737-2223.

  • When do hallucinations or delusions usually occur?

    The hallucinations or delusions generally happen in the advanced (late) stages of Parkinson's disease.

  • What are the risk factors for hallucinations and delusions?

    There are a number of possible risk factors for hallucinations and delusions related to Parkinson's disease psychosis. A few risk factors may include dopaminergic medication use (e.g., Gocovri, the brand name of amantadine) and longer disease duration.

How Can I Stay Healthy While Taking Nuplazid?

If you're taking Nuplazid, chances are Parkinson's disease has been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with PD does have its challenges, there are ways to help improve your quality of life. Consider these general tips to support your health:

  • Take PD-related medications as recommended by your healthcare provider.
  • Let your healthcare provider know how your PD medications are affecting you. They will make any necessary adjustments to improve PD symptoms and limit side effects.
  • Try to incorporate a healthy diet. A healthy diet with plenty of fiber and water may minimize constipation and dehydration side effects from some of your medications.
  • Exercise regularly. Exercising might slow down the progressive nature of PD.
  • Let your loved ones know about your PD when you're ready. By improving their awareness, they can better support you with daily tasks, home safety, medical equipment, and more.
  • Consider participating in support groups or seeing a mental health professional to help you find coping strategies that change the way you think, feel, react, or respond to living with PD.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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