Prescription medicine
Pimavanserin Brand names: Nuplazid
Pimavanserin (Nuplazid) is a prescription medicine with an FDA approval on record since 2016. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $170.50 per Nuplazid 34 mg capsule.
- Generic approved
- Boxed warning
Check it at the source: the pimavanserin FDA label on DailyMed (effective June 18, 2026, Acadia Pharmaceuticals Inc.); the NDA 207318 record on Drugs@FDA; every pimavanserin label on DailyMed.
Highlights of the record
FDA label of June 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease.
Used for
From the label: indications and usageNUPLAZID ® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ].
Forms and strengths
- 10 mg
- 34 mg
Capsule; coated tablet.
On the market
- Earliest approval on file
- April 29, 2016 Nuplazid, Acadia Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first January 16, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 23, 2037 Nuplazid tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $170.50 per capsule Nuplazid 34 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 55,140 through July 30, 2026
What is pimavanserin used for?
From the label: indications and usageNUPLAZID ® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ]. NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (NUPLAZID), Acadia Pharmaceuticals Inc., effective June 18, 2026 (SPL set 1e6bea44-57d6-4bac-9328-46e1ee59f83b), via openFDA; the full label on DailyMed
Is there a generic for pimavanserin (Nuplazid)?
The FDA approved the first generic pimavanserin on January 16, 2024. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pimavanserin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 5 patents for Nuplazid tablets: the compound patent runs to April 29, 2030 (pediatric exclusivity to October 29, 2030), and the last listed entry to September 23, 2037; a patent listed only for Nuplazid capsules runs to February 27, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2024 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pimavanserin (Nuplazid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $170.50 per Nuplazid 34 mg capsule. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nuplazid 34 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nuplazid 34 mg capsule | Brand | $170.50 per capsule | $5,114.88 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the pimavanserin label say about other medicines?
The pimavanserin label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name pimavanserin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone … |
| Carbidopa and levodopa | drug interactions | Clinical Impact: Concomitant use of NUPLAZID with strong or moderate CYP3A4 inducers reduces pimavanserin exposure. Intervention: Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID [see Dosage and Administration (2.3) ]. Interactions with NUPLAZID Based on pharmacokinetic studies, no dosage adjustment of … |
| Chlorpromazine | warnings and precautions | … Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin) [see Drug Interactions (7.1) ]. |
| Gatifloxacin | warnings and precautions | … antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin) [see Drug Interactions (7.1) ]. |
| Moxifloxacin | warnings and precautions | … medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin) [see Drug Interactions (7.1) ]. |
| Procainamide | warnings and precautions | The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone … |
| Quinidine | warnings and precautions | The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone … |
| Sotalol | warnings and precautions | The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone … |
| Thioridazine | warnings and precautions | … antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin) [see Drug Interactions (7.1) ]. |
| Ziprasidone | warnings and precautions | … procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin) [see Drug Interactions (7.1) ]. |
Other labels that name pimavanserin
Source: FDA drug label (NUPLAZID), Acadia Pharmaceuticals Inc., effective June 18, 2026 (SPL set 1e6bea44-57d6-4bac-9328-46e1ee59f83b), via openFDA; the full label on DailyMed
What do FAERS reports show for pimavanserin?
The FDA Adverse Event Reporting System holds 55,140 reports that list pimavanserin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,158 are coded as a death and 9,077 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Pimavanserin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other