Paliperidone side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of ERZOFRI?

ERZOFRI may cause serious side effects, including: See " What is the most important information I should know about ERZOFRI " Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic Malignant Syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms: high fever stiff muscles confusion sweating changes in your breathing, pulse, heart rate, or blood pressure Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms: passing out or feeling like you will pass out dizziness feeling as if your heart is pounding or missing beats Uncontrolled body movements (tardive dyskinesia). […]

What does the label list?

From the label: adverse reactions

The most common adverse reactions in clinical trials in adult subjects with schizophrenia (reported in 5% or more of subjects treated with INVEGA and at least twice the placebo rate in any of the dose groups) were extrapyramidal symptoms, tachycardia, and akathisia.

Table 5. Adverse Reactions Reported by ≥ 2% of INVEGA-Treated Adolescent Subjects with Schizophrenia in a Fixed-Dose, Placebo-Controlled Clinical Trial Table includes adverse reactions that were reported in 2% or more…

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] QT prolongation [see Warnings and Precautions (5.4) ] Tardive dyskinesia [see Warnings and Precautions (5.5) ] Metabolic changes [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Potential for gastrointestinal obstruction [see Warnings and Precautions (5.8) ] Orthostatic hypotension and syncope [see Warnings and Precautions (5.9) ] Falls [see Warnings and Precautions (5.10) ] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.11) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Dysphagia [see Warnings and Precautions (5.14) ] Priapism [see Warnings and Precautions (5.15) ] Disruption of body temperature regulation [see Warnings and Precautions (5.16) ] Commonly observed adverse reactions (incidence ≥ 5% and at least twice that for placebo) were ( 6 ) Adults with schizophrenia: extrapyramidal …

What do FAERS reports show?

52,997 reports list paliperidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,941 are coded as a death and 10,748 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. Of the 16 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

• 5,851
• 6,099
• 2,927
• 2,779
• 2,536
• 2,670
• 3,742
• 3,254
• 3,021
• 3,109
• 1,545

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The 25 most reported reactions

• Off Label Use (a use or a product term, not a reaction)4,570
• Injury4,362
• Gynaecomastia (named in the label)4,232
• Drug Ineffective (a use or a product term, not a reaction)3,607
• Weight Increased (named in the label)2,843
• Hospitalisation (an outcome recorded in the report)2,188
• Abnormal Weight Gain1,828
• Galactorrhoea (named in the label)1,657
• Drug Dose Omission (a use or a product term, not a reaction)1,614
• Schizophrenia (a use or a product term, not a reaction)1,608
• Hyperprolactinaemia (named in the label)1,520
• Product Dose Omission Issue (a use or a product term, not a reaction)1,517
• Treatment Noncompliance1,481
• Condition Aggravated (a use or a product term, not a reaction)1,332
• Psychotic Disorder1,283
• Blood Prolactin Increased1,275
• Product Use In Unapproved Indication (a use or a product term, not a reaction)1,183
• Sedation (named in the label)1,072
• Insomnia (named in the label)1,025
• Somnolence (named in the label)1,014
• Tremor (named in the label)1,002
• Dyskinesia (named in the label)995
• Anxiety (named in the label)990
• Extrapyramidal Disorder (named in the label)973
• Incorrect Dose Administered (a use or a product term, not a reaction)963

What next?

Paliperidone: the full record

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