Nuplazidpimavanserin
According to the FDA label: NUPLAZID ® 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. ( 1 )
52,308 adverse event reports submitted to the FDA (2015–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nuplazid in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Hallucination 12,112 reports
Seeing, hearing, or sensing things that are not actually there. The term records what was reported and does not establish that a medication was the cause.
Full definition in the glossary →Death 10,409 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Drug Ineffective 6,061 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Product Dose Omission Issue 4,195 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Confusional State 4,110 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Fall 3,821 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →- Delusion 2,640 reports
Condition Aggravated 2,244 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →- Hallucination, Visual 2,183 reports
- Parkinson^s Disease 2,181 reports
Gait Disturbance 2,104 reports
Difficulty walking normally, such as an unsteady or altered way of walking.
Full definition in the glossary →Urinary Tract Infection 1,716 reports
An infection in the bladder, urethra, or kidneys, often called a UTI.
Full definition in the glossary → See all drugs reporting this event →Somnolence 1,667 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Peripheral Swelling 1,593 reports
Swelling in the arms, legs, hands, or feet, often from fluid buildup.
Full definition in the glossary → See all drugs reporting this event →Adverse Drug Reaction 1,585 reports
A general report of a harmful or unintended response to a medication, used when no more specific reaction is named.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 31,462 |
| Female | 19,941 |
| Unknown | 3 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 7 |
| 18-34 | 36 |
| 35-49 | 96 |
| 50-64 | 1,592 |
| 65-74 | 7,121 |
| 75+ | 15,356 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nuplazid. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 25,955 |
| Other Serious | 20,839 |
| Death | 13,637 |
| Hospitalization | 8,586 |
| Life-Threatening | 78 |
| Disability | 66 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nuplazid. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2015 | 2 |
| 2016 | 1,269 |
| 2017 | 4,548 |
| 2018 | 4,467 |
| 2019 | 2,606 |
| 2020 | 5,917 |
| 2021 | 4,703 |
| 2022 | 4,300 |
| 2023 | 4,501 |
| 2024 | 7,183 |
| 2025 | 10,484 |
| 2026 (partial) | 2,328 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nuplazid
In FDA adverse event reports that mention Nuplazid, these medications appeared most often in the same report.
- Carbidopa And Levodopa (6,784 reports)
- Quetiapine (5,141 reports)
- Aspirin (3,635 reports)
- Donepezil (3,329 reports)
- Ergocalciferol (3,111 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026