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Risperdal side effects | Weight gain | Depression | Gynecomastia | Withdrawal | How long do side effects last? | Interactions | How to avoid side effects
Risperdal is a brand-name prescription medication produced by Janssen Pharmaceuticals. It may be used to treat mood disorders like schizophrenia, bipolar disorder, or irritability related to autistic disorder. Risperdal is also available as a generic version, called Risperidone. This article covers Risperdal side effects, warnings, and interactions.
RELATED: Learn more about Risperdal
Common side effects of Risperdal
Common side effects of Risperdal include the following adverse effects:
- Somnolence
- Anxiety
- Dizziness
- Headache
- Increased appetite
- Drowsiness
- Fatigue
- Insomnia
- Rhinitis
- Upper respiratory infection
- Cough
- Urinary incontinence
- Excessive salivation
- Constipation
- Fever
- Dystonia
- Abdominal pain
- Nausea
- Impaired body temperature regulation
- Vomiting
- Rash
- Akathisia
- Dyspepsia
- Tachycardia
- Xerostomia
- Tremor
- Weight gain
- Hyperprolactinemia
- Confusion
- Gynecomastia
- Photosensitivity
- Epistaxis
- Visual disturbance
- Dyslipidemia
- Chest pain
Serious side effects of Risperdal
Serious side effects of Risperdal include the following:
- Stevens-Johnson syndrome
- Hypothermia
- Hyperthermia
- Hypotension, severe
- Syncope
- Neuroleptic malignant syndrome
- Hyperglycemia
- Diabetes mellitus
- Seizures
- Transient Ischemic Attack (TIA)
- Dysphagia, severe
- Hypersensitivity reaction
- Angioedema
- Anaphylaxis
- Extrapyramidal symptoms, severe
- Tardive dyskinesia
- Erythema multiforme
- Toxic epidermal necrolysis
- Leukopenia
- Neutropenia
- Priapism
- Stroke
- Agranulocytosis
Weight gain
Research suggests that Risperdal is linked to weight gain. One study published by the manufacturer compared weight gain in a test group of schizophrenic adults taking Risperdal versus a placebo group of schizophrenic adults not taking Risperdal.
The results showed a statistically significant increase in the incidence of weight gain in the group of adults taking Risperdal, with 18% of those patients gaining substantial weight. In comparison, only 9% of the adults in the placebo group gained significant weight. For this study, significant weight gain was defined as a gain of more than 7% of the individual’s body weight over a six to eight-week period.
While weight gain in itself may not warrant immediate medical attention, obesity generally increases the risk of various diseases, including cardiovascular disease, diabetes, sleep apnea, osteoarthritis, and cancer. Affected individuals should consult with a healthcare professional regarding healthy weight management options.
Depression
According to the National Alliance on Mental Illness, Risperidone may sometimes be prescribed “off-label” as an adjunct treatment for depressive disorders (e.g., it’s prescribed in addition to an antidepressant). Off-label means that the Food and Drug Administration (FDA) has not approved the medication for the treatment of this specific condition.
A study published in the Journal of Clinical Psychiatry examined Risperidone and suicidality in individuals with major depressive disorder, MDD. The study looked at the efficacy of Risperidone as an adjunct antidepressant treatment for individuals with MDD with suicidal thoughts. The results suggest that Risperidone may be beneficial in augmenting treatment for MDD patients with high-risk suicidal ideation and may be especially useful in managing severe depressive symptoms.
A study published in PLOS ONE investigated the all-cause mortality risk of antipsychotic augmentation for adult depression. It concluded that augmentation with newer antipsychotics was associated with a greater mortality risk when compared with the alternative of adding a second antidepressant.
Although the study alone cannot prove causality, the study’s conclusions recommend healthcare providers be aware of this potential for more significant mortality associated with newer psychotic augmentation.
Depressive symptoms, in particular suicidal ideation, are a high-risk health issue. Affected individuals should report to a healthcare professional as soon as possible.
Gynecomastia
Research suggests that Risperdal is linked to gynecomastia, the technical term for enlargement of male breasts.
One study published by the Food and Drug Administration suggests that Risperdal intake may be associated with a slightly heightened risk of gynecomastia. The clinical trial studied 1885 adolescents and children. Gynecomastia was reported in 2.3% of those patients treated with Risperdal.
Gynecomastia may slightly increase an individual’s risk of developing male breast cancer (change resource?). Although the heightened risk is small, it’s advisable to consult a healthcare professional in case of complications.
Withdrawal
Research suggests that Risperdal may be habit-forming. Possible symptoms of withdrawal include dizziness, sleepiness, nausea, and returning schizophrenic symptoms.
A withdrawal study published by the manufacturer examined patients who had shown a positive response to Risperdal (defined as at least a 25% improvement according to the defined scale) over four to six months. The patients were randomly assigned into a placebo and a test group to examine withdrawal. An analysis of patients who completed the withdrawal study showed a significantly lower relapse rate in Risperdal patients versus the placebo group.
A case study published in the Psychopharmacology Bulletin examined an instance of akathisia induced by abrupt Risperidone withdrawal. Akathisia is a movement disorder that has previously been associated with withdrawal of antipsychotic treatment.
In case of withdrawal symptoms, individuals should consult a healthcare professional. Patients on Risperdal should consult their physician about making any changes to dosage or intake.
How long do Risperdal side effects last?
According to the National Alliance on Mental Health (as cited above), some Risperdal side effects may be temporary, while others may be permanent.
Common side effects are often temporary. Some more severe side effects may be more lasting. These include extrapyramidal symptoms, EPS, or tardive dyskinesia, TD. These are muscle-related issues that may result in tremors, stiffness, and restlessness. Janssen Pharmaceuticals, the manufacturer of Risperdal, reveals that in some instances, these side effects may be permanent, in particular with the use of the injectable Risperdal Consta.
Risperdal contraindications & warnings
Risperdal is not suitable for everyone. The pharmaceutical is contraindicated for patients with hypersensitivity to the drug/class/component and/or hypersensitivity to paliperidone.
Further, caution is urged for patients meeting the following criteria:
- Pregnancy 3rd trimester
- PKU (phenylalanine-containing forms)
- Elderly patients
- Dementia-related psychosis
- Dementia w/ Lewy bodies
- Parkinson disease
- Neuroleptic malignant syndrome history
- Diabetes mellitus
- Diabetes mellitus risk
- Cerebrovascular disease
- Hypotension
- Hypovolemia
- High environmental temperature
- Aspiration pneumonia risk
- Drug-induced leukopenia or neutropenia history
- Leukopenia or neutropenia
- Renal impairment
- Hepatic impairment
- Seizure history
- Seizure risk
- Cardiovascular disease
Elderly patients with dementia-related psychosis treated with antipsychotics, including Risperdal, are at an increased risk of death. This drug, in any of its forms, is not approved for use in patients with dementia-related psychosis.
An overdose of Risperdal can be fatal. One case of an overdose of 36 mg taken orally was associated with a seizure, a potentially fatal health incident.
Risperdal is available in various dosage forms and strengths. Tablets are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg doses. Oral solutions are available in a 1 mg/mL dose. Finally, orally disintegrating tablets are available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg doses.
There are also injectable forms of Risperdal. Risperdal Consta® and Perseris®. These long-acting injections contain the same medication as the tablet form, but have different FDA-approved uses than the oral formulations.
Dosage recommendations for oral Risperidone are as follows:
| Condition | Initial Dose | Titration | Target Dose | Effective Dose Range |
| Schizophrenia in adults | 2 mg/day | 1-2 mg daily | 4-8 mg daily | 4-16 mg/day |
| Schizophrenia in adolescents | 0.5 mg/day | 0.5- 1 mg daily | 3 mg daily | 1-6 mg/day |
| Bipolar mania in adults | 2-3 mg/day | 1mg daily | 1-6 mg daily | 1-6 mg/day |
| Bipolar mania in children/ adolescents | 0.5 mg/day | 0.5-1 mg daily | 2.5 mg daily | 0.5-6 mg/day |
| Irritability associated with autistic disorder | 0.25 mg/day (<20 kg) 0.5 mg /day (≥20 kg) | 0.25-0.5 mg at ≥ 2 weeks | 0.5 mg daily (if <20 kg) or 1 mg /day (≥20 kg) | 0.5-3 mg/day |
Risperdal interactions
The FDA-approved label for Risperdal notes the following drug interactions:
- It’s advised to use caution when administering Risperdal with other drugs that act on the central nervous system (CNS) due to increased CNS effects.
- Alcohol use should be avoided as it also increases CNS effects of risperidone.
- Hypotensive effects of other drugs or drugs with hypotensive potential may be enhanced due to Risperdal‘s hypotensive effects.
- Levodopa and dopamine agonists’ effects may be antagonized.
- The bioavailability of Risperidone is increased with Cimetidine and Ranitidine.
- Clearance of Risperidone may decrease with Clozapine.
- Plasma concentrations of risperidone increase with Fluoxetine and Paroxetine.
- Plasma concentrations of risperidone decrease with Carbamazepine and other enzyme inducers.
Risperidone may interact with certain drugs, with interaction characteristics including:
- Decreases central histamine effects
- Hyperglycemic effects
- CNS depression
- CYP2D6 substrate
- Extrapyramidal effects
- CYP3A4 substrate
- Hypotensive effects
- Hyperprolactinemic effects, strong
- Lowers seizure threshold
Always consult a physician for drug information and possible contraindications before taking any new medication or mixing any medicines, including over-the-counter drugs, supplements, and herbal preparations.
How to avoid Risperdal side effects
Individuals should only take Risperdal per the guidance, and prescription, of a physician. Specific steps can help reduce the likelihood or severity of side effects, including:
- Taking the appropriate dosage: Risperdal should be taken as agreed upon with the patient’s doctor. In general, coated tablets should be swallowed whole with water. Orodispersible tablets should be allowed to “melt” on the tongue and then washed down with water if needed. The oral solution can be diluted in a nonalcoholic drink or swallowed as is. However, the oral solution should not be mixed with beverages containing tannins, including tea or cola.
- Providing the prescribing physician with a detailed medical history: Patients should give all details of their full health history to their doctor before taking Risperdal. Risperdal is contraindicated for any patient with known hypersensitivity to Risperidone.
- Reviewing all possible interactions with the physician: Patients should further consult with their physicians on what drugs or foods could negatively affect them while taking Risperdal. For example, Risperdal should never be taken with alcohol.
In particular, caution should be taken in case contraindications and/or warnings apply.
FAQs
Does Risperdal need to be taken every day?
For Risperdone to work effectively, it should be taken as ordered by the prescribing healthcare provider. For individuals taking the tablet form, this may mean taking Risperdal one to two times per day.
What are other forms of Risperdal?
An injectable form of Risperdal, known as Risperdal Consta, is also available. This is generally meant to be administered by a healthcare provider every two weeks. Perseris is another type of long-acting injectable form and must generally be issued on a monthly basis.
How long is it safe to take Risperdal?
According to the Food and Drug Administration, it is unknown how long a patient with schizophrenia should continue to take Risperdal. Risperdal is approved for long-term use when treating schizophrenia or irritability associated with autistic disorder. Periodic reassessment is recommended to determine the need for maintenance treatment and adjust dosage as needed.
When used in the pediatric population, Rispderal is approved for long-term use when treating schizophrenia in children aged 13-17 years old, or irritability associated with autistic disorder in children 5-16 years old. It is approved for short-term use when treating episodes of Bipolar I Disorder in children aged 10-17 years.
