72/100 · Elevated
Manufactured by Janssen Pharmaceuticals, Inc.
Paliperidone Palmitate Adverse Events: Weight Increase and Psychiatric Symptoms Predominate
48,953 FDA adverse event reports analyzed
Last updated: 2026-05-12
PALIPERIDONE PALMITATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 48,953 FDA adverse event reports, PALIPERIDONE PALMITATE has a safety score of 72 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 PALIPERIDONE PALMITATE include OFF LABEL USE, DRUG INEFFECTIVE, HOSPITALISATION, WEIGHT INCREASED, DRUG DOSE OMISSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PALIPERIDONE PALMITATE.
Paliperidone Palmitate has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 48,953 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Hospitalisation. Of classified reports, 42.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Weight increase is a common adverse event, with 1599 reports.
Psychiatric symptoms such as hallucinations and depression are frequently reported, with 660 and 575 reports respectively. Serious adverse events account for 42.7% of all reports, indicating a notable proportion of severe incidents.
Patients taking Paliperidone Palmitate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Paliperidone Palmitate can cause weight gain and psychiatric symptoms, and should be used with caution in patients with a history of these conditions. Drug interactions are not specifically warned against, but patients should inform their healthcare This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paliperidone Palmitate received a safety concern score of 72/100 (elevated concern). This is based on a 42.7% serious event ratio across 30,702 classified reports. The score accounts for 48,953 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 14,065, Female: 9,170, Unknown: 395. The most frequently reported age groups are age 23 (388 reports), age 32 (360 reports), age 3 (358 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,702 classified reports for PALIPERIDONE PALMITATE:
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.
Paliperidone Palmitate can cause weight gain and psychiatric symptoms, and should be used with caution in patients with a history of these conditions. Drug interactions are not specifically warned against, but patients should inform their healthcare
If you are taking Paliperidone Palmitate, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, hospitalisation, weight increased, drug dose omission. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of weight gain and psychiatric symptoms, and adjust treatment as necessary. Inform patients about the potential for serious adverse events, including death and suicide attempts, and encourage them to report any concerning symptoms. 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 Paliperidone Palmitate for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should adhere to prescribed dosages and schedules, and report any side effects to their
The FDA has received approximately 48,953 adverse event reports associated with Paliperidone Palmitate. 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 Paliperidone Palmitate include Off Label Use, Drug Ineffective, Hospitalisation, Weight Increased, Drug Dose Omission. By volume, the top reported reactions are: Off Label Use (2,954 reports), Drug Ineffective (2,164 reports), Hospitalisation (1,743 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Paliperidone Palmitate.
Out of 30,702 classified reports, 13,099 (42.7%) were classified as serious and 17,603 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 Paliperidone Palmitate break down by patient sex as follows: Male: 14,065, Female: 9,170, Unknown: 395. 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 Paliperidone Palmitate adverse events are: age 23: 388 reports, age 32: 360 reports, age 3: 358 reports, age 30: 351 reports, age 26: 304 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 Paliperidone Palmitate adverse event reports is Janssen 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 Paliperidone Palmitate include: Product Dose Omission Issue, Gynaecomastia, Schizophrenia, Condition Aggravated, Treatment Noncompliance. 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 Paliperidone Palmitate 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.
Paliperidone Palmitate has a safety concern score of 72 out of 100 (elevated 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. Weight increase is a common adverse event, with 1599 reports.
Key safety signals identified in Paliperidone Palmitate's adverse event data include: Weight increase is a significant safety signal, with a high number of reports.. Psychotic symptoms and depression are also key safety signals, with multiple reports of hallucinations and depression.. Serious adverse events, including death and suicide attempts, are reported at a concerning rate.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Paliperidone Palmitate can cause weight gain and psychiatric symptoms, and should be used with caution in patients with a history of these conditions. Drug interactions are not specifically warned against, but patients should inform their healthcare Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paliperidone Palmitate.
Monitor patients for signs of weight gain and psychiatric symptoms, and adjust treatment as necessary. Inform patients about the potential for serious adverse events, including death and suicide attempts, and encourage them to report any concerning symptoms.
Paliperidone Palmitate has 48,953 adverse event reports on file with the FDA. Psychiatric symptoms such as hallucinations and depression are frequently reported, with 660 and 575 reports respectively. The volume of reports for Paliperidone Palmitate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Paliperidone Palmitate for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should adhere to prescribed dosages and schedules, and report any side effects to their For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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