82/100 · Critical
Manufactured by Acadia Pharmaceuticals Inc.
High Safety Concerns with Pimavanserin Tartrate, Particularly for Elderly Patients
106,130 FDA adverse event reports analyzed
Last updated: 2026-05-12
PIMAVANSERIN TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Acadia Pharmaceuticals Inc.. Based on analysis of 106,130 FDA adverse event reports, PIMAVANSERIN TARTRATE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PIMAVANSERIN TARTRATE include HALLUCINATION, DEATH, DRUG INEFFECTIVE, PRODUCT DOSE OMISSION ISSUE, CONFUSIONAL STATE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PIMAVANSERIN TARTRATE.
Pimavanserin Tartrate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 106,130 adverse event reports for this medication, which is primarily manufactured by Acadia Pharmaceuticals Inc..
The most commonly reported adverse events include Hallucination, Death, Drug Ineffective. Of classified reports, 49.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Significant reports of hallucinations and confusion, especially in elderly patients.
High incidence of falls and gait disturbances, posing a risk of injury. Multiple serious adverse events, including death and pneumonia, reported frequently. Drug ineffectiveness and underdose issues are common, indicating potential dosing problems. Insomnia and somnolence are prevalent, affecting sleep patterns.
Patients taking Pimavanserin Tartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pimavanserin Tartrate can cause falls and gait disturbances, which may lead to injuries. Patients should be monitored for these symptoms, especially in elderly patients. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pimavanserin Tartrate received a safety concern score of 82/100 (high concern). This is based on a 49.7% serious event ratio across 49,722 classified reports. The score accounts for 106,130 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 29,876, Female: 18,963, Unknown: 3. The most frequently reported age groups are age 78 (1,280 reports), age 76 (1,262 reports), age 77 (1,226 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 49,722 classified reports for PIMAVANSERIN TARTRATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Pimavanserin Tartrate can cause falls and gait disturbances, which may lead to injuries. Patients should be monitored for these symptoms, especially in elderly patients.
If you are taking Pimavanserin Tartrate, here are important things to know. The most commonly reported side effects include hallucination, death, drug ineffective, product dose omission issue, confusional state. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Elderly patients should be closely monitored for falls and gait disturbances due to the increased risk of injury. Ensure proper dosing and follow the prescribed schedule to avoid underdose or overdose issues. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Pimavanserin Tartrate, and the drug has been approved for treatment of Parkinson's disease with psychosis. However, healthcare providers should be vigilant about potential serious adverse events and monitor
The FDA has received approximately 106,130 adverse event reports associated with Pimavanserin Tartrate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Pimavanserin Tartrate include Hallucination, Death, Drug Ineffective, Product Dose Omission Issue, Confusional State. By volume, the top reported reactions are: Hallucination (11,532 reports), Death (9,921 reports), Drug Ineffective (5,804 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pimavanserin Tartrate.
Out of 49,722 classified reports, 24,692 (49.7%) were classified as serious and 25,030 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Pimavanserin Tartrate break down by patient sex as follows: Male: 29,876, Female: 18,963, Unknown: 3. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Pimavanserin Tartrate adverse events are: age 78: 1,280 reports, age 76: 1,262 reports, age 77: 1,226 reports, age 79: 1,182 reports, age 75: 1,151 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Pimavanserin Tartrate adverse event reports is Acadia Pharmaceuticals Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Pimavanserin Tartrate include: Fall, Delusion, Parkinson^S Disease, Condition Aggravated, Hallucination, Visual. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Pimavanserin Tartrate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Pimavanserin Tartrate has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Significant reports of hallucinations and confusion, especially in elderly patients.
Key safety signals identified in Pimavanserin Tartrate's adverse event data include: High frequency of hallucinations and delusions, particularly visual hallucinations.. Frequent reports of falls and gait disturbances, especially in elderly patients.. Multiple serious adverse events, including death and pneumonia, are reported.. Drug ineffectiveness and underdose issues are common, indicating potential dosing problems.. Insomnia and somnolence are prevalent, affecting sleep patterns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pimavanserin Tartrate can cause falls and gait disturbances, which may lead to injuries. Patients should be monitored for these symptoms, especially in elderly patients. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pimavanserin Tartrate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Elderly patients should be closely monitored for falls and gait disturbances due to the increased risk of injury. Ensure proper dosing and follow the prescribed schedule to avoid underdose or overdose issues.
Pimavanserin Tartrate has 106,130 adverse event reports on file with the FDA. High incidence of falls and gait disturbances, posing a risk of injury. The volume of reports for Pimavanserin Tartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Pimavanserin Tartrate, and the drug has been approved for treatment of Parkinson's disease with psychosis. However, healthcare providers should be vigilant about potential serious adverse events and monitor For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with PIMAVANSERIN TARTRATE:
Drugs related to PIMAVANSERIN TARTRATE based on therapeutic use, drug class, or shared indications: