From the FDA Drug Label
The most common adverse reactions in clinical trials in adult subjects with schizophrenia (reported in 5% or more of subjects treated with paliperidone and at least twice the placebo rate in any of the dose groups) were extrapyramidal symptoms, tachycardia, and akathisia The most common adverse reactions in clinical trials in adult patients with schizoaffective disorder (reported in 5% or more of subjects treated with paliperidone and at least twice the placebo rate) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis, Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis, Neuroleptic malignant syndrome, QT prolongation, Tardive dyskinesia, Metabolic changes, Hyperprolactinemia, Potential for gastrointestinal obstruction, Orthostatic hypotension and syncope, Falls, Leukopenia, neutropenia, and agranulocytosis, Potential for cognitive and motor impairment, Seizures, Dysphagia, Priapism, Disruption of body temperature regulation
The side effects of Paliperidone (Invega) include:
- Extrapyramidal symptoms
- Tachycardia
- Akathisia
- Somnolence
- Dyspepsia
- Constipation
- Weight increased
- Nasopharyngitis
- Increased mortality in elderly patients with dementia-related psychosis
- Cerebrovascular adverse reactions
- Neuroleptic malignant syndrome
- QT prolongation
- Tardive dyskinesia
- Metabolic changes
- Hyperprolactinemia
- Potential for gastrointestinal obstruction
- Orthostatic hypotension and syncope
- Falls
- Leukopenia, neutropenia, and agranulocytosis
- Potential for cognitive and motor impairment
- Seizures
- Dysphagia
- Priapism
- Disruption of body temperature regulation 1 1
From the Research
Paliperidone can cause several side effects, including drowsiness, dizziness, weight gain, and extrapyramidal symptoms, as well as more serious effects like neuroleptic malignant syndrome and QT prolongation, as reported in studies such as 2 and 3.
Common Side Effects
- Drowsiness/lethargy (28.7%)
- Tachycardia (23.3%)
- Dystonia (14.2%)
Serious Side Effects
- Neuroleptic malignant syndrome (fever, muscle rigidity, confusion)
- Tardive dyskinesia (involuntary movements that may become permanent)
- QT prolongation (heart rhythm abnormality)
Metabolic Changes
- Elevated blood sugar
- Cholesterol and triglycerides
Hormonal Effects
- Increased prolactin levels
- Breast enlargement
- Decreased sexual desire
- Irregular menstruation in women
- Erectile dysfunction in men
Monitoring and Precautions
Patients should have regular monitoring of weight, blood sugar, lipids, and heart function while taking paliperidone, as recommended by studies such as 4 and 3. If severe side effects occur, patients should contact their healthcare provider immediately rather than stopping the medication abruptly, as severe side effects can be life-threatening, as reported in a case study 5. It is essential to be aware of the potential side effects of paliperidone, including the rare but serious conditions like pericardial effusion, as reported in a case study 6. Overall, the side effect profile of paliperidone is generally predictable and manageable, but it requires careful monitoring and precautions to minimize the risk of adverse effects, as discussed in studies such as 2 and 3.