From the Guidelines
Risperidone can have significant long-term effects with extended use, including metabolic changes, neurological effects, and hyperprolactinemia, which must be carefully monitored and managed to minimize risks while maintaining symptom control. The long-term effects of risperidone include metabolic changes such as weight gain, increased blood glucose levels, and elevated cholesterol, which may lead to diabetes and cardiovascular issues over time 1. Neurological effects can also develop, particularly tardive dyskinesia (involuntary movements) which may become permanent even after stopping the medication, with risperidone being more likely to produce extrapyramidal side effects compared to other atypical antipsychotic agents 1. Risperidone can cause hyperprolactinemia (elevated prolactin hormone), potentially resulting in sexual dysfunction, menstrual irregularities, breast enlargement, and bone density loss with prolonged exposure. Some patients experience cognitive dulling or emotional blunting with long-term use.
These risks must be balanced against the benefits of symptom control for conditions like schizophrenia, bipolar disorder, or severe behavioral problems. Regular monitoring is essential, including weight checks, metabolic panels, movement assessments, and prolactin level testing, with screening for prediabetes or diabetes at baseline, rescreened 12–16 weeks after medication initiation, and screened annually thereafter 1. The lowest effective dose should be used, and periodic attempts to reduce the dose may be appropriate for some patients to minimize long-term risks while maintaining symptom control. It is crucial to consider the potential long-term effects of risperidone and to carefully weigh the benefits against the risks for each individual patient.
Key considerations for minimizing long-term risks include:
- Regular monitoring of metabolic parameters and movement assessments
- Screening for prediabetes or diabetes at baseline and regularly thereafter
- Using the lowest effective dose and attempting to reduce the dose periodically
- Carefully weighing the benefits against the risks for each individual patient
- Being aware of the potential for hyperprolactinemia and its associated effects.
From the FDA Drug Label
The long-term effects of RISPERIDONE on growth and sexual maturation have not been fully evaluated in children and adolescents. Juvenile dogs were treated for 40 weeks with oral risperidone doses of 0.31,1. 25, or 5 mg/kg/day. Decreased bone length and density were seen, with a no-effect dose of 0. 31 mg/kg/day. In addition, a delay in sexual maturation was seen at all doses in both males and females The above effects showed little or no reversibility in females after a 12 week drug-free recovery period.
The long-term effects of Risperidone are not fully evaluated in children and adolescents, but available data from juvenile animal studies suggest potential effects on growth and sexual maturation 2 2.
- Decreased bone length and density were observed in juvenile dogs.
- Delay in sexual maturation was seen in both males and females.
- These effects showed little or no reversibility in females after a 12-week drug-free recovery period.
From the Research
Long-term Effects of Risperidone
The long-term effects of Risperidone have been studied in various populations, including patients with schizophrenia, major depressive disorder, and children with severe disruptive behaviors or autism spectrum disorders.
- In patients with schizophrenia, Risperidone has been shown to be effective and safe for long-term treatment, with significant improvement in symptoms and health-related quality of life 3, 4.
- In patients with major depressive disorder, Risperidone augmentation has been found to be effective and safe when used at low doses, with improvement in depressive symptoms and few adverse effects 5.
- In children with severe disruptive behaviors and below-average IQ, long-term Risperidone treatment has been associated with rapid and significant improvement in symptoms, with a mean weight increase of 5.5 kg and few adverse events 6.
- In children with autism spectrum disorders, Risperidone has been found to be effective in reducing disruptive behavior, with a significant difference in relapse rates between patients continuing on Risperidone and those switching to placebo 7.
Adverse Effects
The adverse effects of long-term Risperidone treatment have been reported in various studies, including:
- Dose-dependent adverse events, such as somnolence, headache, and weight gain 3, 6.
- Increased appetite, anxiety, and fatigue 7.
- Transient and asymptomatic increases in prolactin levels 6.
- Extrapyramidal symptoms, which have been found to improve from baseline following administration of Risperidone 4.
Efficacy and Safety
The efficacy and safety of long-term Risperidone treatment have been demonstrated in various studies, with significant improvement in symptoms and few adverse effects.
- In patients with schizophrenia, Risperidone has been shown to be effective and safe for long-term treatment, with significant improvement in symptoms and health-related quality of life 3, 4.
- In patients with major depressive disorder, Risperidone augmentation has been found to be effective and safe when used at low doses, with improvement in depressive symptoms and few adverse effects 5.
- In children with severe disruptive behaviors and below-average IQ, long-term Risperidone treatment has been associated with rapid and significant improvement in symptoms, with a mean weight increase of 5.5 kg and few adverse events 6.
- In children with autism spectrum disorders, Risperidone has been found to be effective in reducing disruptive behavior, with a significant difference in relapse rates between patients continuing on Risperidone and those switching to placebo 7.