paliperidone Side Effects
Also known as: Invega
Analysis of 22,775 adverse event reports submitted to the FDA from 2007 to 2025.
Total Reports
22,775
Death-Related
801
3.5% of reports
Hospitalizations
4,563
20.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 801 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 213 |
| DEATH | 153 |
| TOXICITY TO VARIOUS AGENTS | 107 |
| DRUG INEFFECTIVE | 58 |
| SCHIZOPHRENIA | 52 |
| DYSTONIA | 47 |
| BLOOD GLUCOSE INCREASED | 45 |
| DYSKINESIA | 45 |
| SEDATION | 45 |
| SUICIDE ATTEMPT | 45 |
| CONDITION AGGRAVATED | 44 |
| METABOLIC DISORDER | 43 |
| ANOSOGNOSIA | 42 |
| BLOOD PROLACTIN ABNORMAL | 42 |
| DISTURBANCE IN SOCIAL BEHAVIOUR | 42 |
| SEXUAL DYSFUNCTION | 42 |
| PERSONALITY CHANGE | 41 |
| ADVERSE DRUG REACTION | 34 |
| OFF LABEL USE | 32 |
| OVERDOSE | 32 |
Reactions in Hospitalization Reports
Top reactions in 4,563 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 503 |
| HOSPITALISATION | 492 |
| OFF LABEL USE | 307 |
| SCHIZOPHRENIA | 250 |
| TREATMENT NONCOMPLIANCE | 245 |
| PSYCHOTIC DISORDER | 236 |
| WEIGHT INCREASED | 210 |
| NEUROLEPTIC MALIGNANT SYNDROME | 196 |
| EXTRAPYRAMIDAL DISORDER | 191 |
| TACHYCARDIA | 187 |
| SOMNOLENCE | 184 |
| DRUG INTERACTION | 183 |
| TREMOR | 182 |
| SUICIDE ATTEMPT | 179 |
| CONFUSIONAL STATE | 176 |
| OVERDOSE | 163 |
| AGGRESSION | 161 |
| ANXIETY | 155 |
| CONDITION AGGRAVATED | 146 |
| SUICIDAL IDEATION | 145 |
Nearby — Related Medications
What the FAERS Data Reveals About paliperidone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 22,775 voluntary reports linked to paliperidone and its brand equivalents (Invega), spanning 2007 through 2025. Of those, 801 (3.5%) listed death as an outcome and 4,563 (20.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 31% were female and 68% male; age distribution skews toward 18-44, with 5,235 reports in that bracket. The single most reported reaction is injury with 4,331 submissions, followed by gynaecomastia and drug ineffective.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.