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Drowsiness, dizziness, lightheadedness, drooling, nausea, weight gain, or tiredness may occur. Drug interactions may change how your medications work or increase your risk for serious side effects. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals.
Wright & Schulte LLC is Investigating Risperdal Lawsuits on Behalf of Patients Who Used the Atypical Antipsychotic and Developed Gynecomastia, also Known as Male Breast Growth. Victims of gynecomastia associated with the use of Risperdal may be eligible to file a Risperdal lawsuit. Wright & Schulte LLC, an experienced law firm representing clients in Risperdal lawsuits, announces they have launched a new Facebook page to provide the public with the most up-to-date information regarding the ongoing litigation of Risperdal gynecomastia claims. Risperdal is an atypical antipsychotic drug used to treat a number of psychiatric disorders, including bipolar disorder and schizophrenia. According to court documents, some plaintiffs in Risperdal lawsuits that involve gynecomastia allegations claim they were forced to undergo liposuction or mastectomies to remove excess breast tissue. Victims of gynecomastia allegedly associated with the use of Risperdal may be eligible to file their own Risperdal lawsuit.
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Reach out to the author: contact and available social following information is listed in the top-right of all news releases.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperdal® is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
Risperdal® adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Risperdal® is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.
Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off Risperdal®, the initial titration schedule should be followed. There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to Risperdal®, or treating patients with concomitant antipsychotics.
There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with Risperdal®. The dosage of Risperdal® should be individualized according to the response and tolerability of the patient. Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose. Risperdal® Oral Solution can be administered directly from the calibrated pipette, or can be mixed with a beverage prior to administration. Risperdal® (risperidone) is not approved for the treatment of dementia-related psychosis [see Boxed Warning]. Antipsychotic drugs including Risperdal® can cause a potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS). If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Given these considerations, prescribe Risperdal® in a manner that is most likely to minimize the occurrence of tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear in a patient treated with Risperdal®, consider drug discontinuation. Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics including Risperdal®.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics, including Risperdal®, should be monitored regularly for worsening of glucose control. Pooled data from three double-blind, placebo-controlled schizophrenia studies and four double-blind, placebo-controlled bipolar monotherapy studies are presented in Table 2. Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Pooled data from 7 placebo-controlled, 3- to 8- week, fixed- or flexible-dose studies in adult subjects with schizophrenia or bipolar mania are presented in Table 4. Data on mean changes in body weight and the proportion of subjects meeting a weight gain criterion of 7% or greater of body weight from 7 placebo-controlled, 3- to 8- week, fixed- or flexible-dose studies in adult subjects with schizophrenia or bipolar mania are presented in Table 6.
In a long-term, open-label extension study in adolescent patients with schizophrenia, weight increase was reported as a treatment-emergent adverse event in 14% of patients. When treating pediatric patients with Risperdal® for any indication, weight gain should be assessed against that expected with normal growth.
As with other drugs that antagonize dopamine D2 receptors, Risperdal® elevates prolactin levels and the elevation persists during chronic administration.
Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer.
Risperdal® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha-adrenergic antagonistic properties. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
Somnolence was a commonly reported adverse reaction associated with Risperdal® treatment, especially when ascertained by direct questioning of patients.
The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
The data described in this section are derived from a clinical trial database consisting of 9803 adult and pediatric patients exposed to one or more doses of Risperdal® for the treatment of schizophrenia, bipolar mania, autistic disorder, and other psychiatric disorders in pediatrics and elderly patients with dementia. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Table 8 lists the adverse reactions reported in 2% or more of Risperdal®-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials. Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, parkinsonism, cogwheel rigidity, akinesia, bradykinesia, hypokinesia, masked facies, muscle rigidity, and Parkinson's disease.

Table 9 lists the adverse reactions reported in 5% or more of Risperdal®-treated pediatric patients with schizophrenia in a 6-week double-blind, placebo-controlled trial. This medication can help you to think clearly and take part in everyday life.Risperidone belongs to a class of drugs called atypical antipsychotics. This product may contain inactive ingredients, which can cause allergic reactions or other problems. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else.
The new Risperdal Side-Effects Facebook page will operate as an adjunct to Wright & Schulte’s main website, and serve as another avenue for clients, potential clients and others who may have questions about the ongoing litigation of product liability lawsuits involving Risperdal.
Court documents indicate that more than 200 Risperdal lawsuits have been filed against Johnson & Johnson in Philadelphia’s Court of Common Pleas in Pennsylvania, all of which allege use of the medication caused patients to suffer serious side effect, including gynecomastia (male breast growth).
Department of Justice in which it agreed to pay $2.2 billion to resolve criminal and civil charges involving the off-label marketing of Risperdal and other drugs. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. Risperdal® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)].
Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)]. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to a recommended dose of 3 mg per day. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode.
The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The total daily dose of Risperdal® can be administered once daily, or half the total daily dose can be administered twice daily. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day.
The physician who elects to use Risperdal® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
The Risperdal® dose should not exceed 8 mg per day in adults when co-administered with these drugs.
For single tablet removal, separate one of the four blister units by tearing apart at the perforations.
All are biconvex and etched on one side with "R0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process.
Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that: (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. However, some patients may require treatment with Risperdal® despite the presence of the syndrome.
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. The majority of that increase occurred within the first 6 months of exposure to Risperdal®.
Risperdal® is associated with higher levels of prolactin elevation than other antipsychotic agents. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.
An increase in pituitary gland, mammary gland, and pancreatic islet cell neoplasia (mammary adenocarcinomas, pituitary and pancreatic adenomas) was observed in the risperidone carcinogenicity studies conducted in mice and rats [see Nonclinical Toxicology (13.1)]. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia.
Both hyperthermia and hypothermia have been reported in association with oral Risperdal® use.
Of these 9803 patients, 2687 were patients who received Risperdal® while participating in double-blind, placebo-controlled trials. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Bloomberg News reported in October 2012 that Johnson & Johnson reached undisclosed settlements in five Risperdal gynecomastia claims filed in the Pennsylvania litigation just before the cases went to trial.
Among other thing, federal prosecutors had charged that Risperdal was improperly marketed for use in children. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events.
Patients should be periodically reassessed to determine the need for maintenance treatment. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. Risperdal® is not approved for the treatment of patients with dementia-related psychosis. Additional signs may include elevated creatine phosphokinase (CPK), myoglobinuria, rhabdomyolysis, and acute renal failure. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought.
While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Any patient treated with atypical antipsychotics, including Risperdal®, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. The average percentiles at baseline and 12 months, respectively, were 49 and 60 for weight, 48 and 53 for height, and 50 and 62 for body mass index. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Risperdal® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Caution is advised when prescribing for patients who will be exposed to temperature extremes. The conditions and duration of treatment with Risperdal® varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures.
Dystonia includes dystonia, muscle spasms, muscle contractions involuntary, muscle contracture, oculogyration, tongue paralysis.
Tell your doctor right away if you develop symptoms of high blood sugar, such as increased thirst and urination.
However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics.
Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics, including Risperdal®, should undergo fasting blood glucose testing. The average percentiles at baseline and 8 months, respectively, were 56 and 72 for weight, 55 and 58 for height, and 51 and 71 for body mass index.
Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects. Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.
Ask your pharmacist about using those products safely.Does Risperdal interact with other medications? Consult your doctor for more details.Missed DoseIf you miss a dose, take it as soon as you remember.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule.
However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended.
The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Do not double the dose to catch up.StorageStore at room temperature away from light and moisture. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. Clinically significant hypotension has been observed with concomitant use of Risperdal® and antihypertensive medication. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. The safety of doses above 16 mg per day has not been evaluated in clinical trials [see Clinical Studies (14.1)]. Consult your pharmacist if you have any questions.The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Take this medication regularly to get the most benefit from it.
For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. Do not stop taking this medication without consulting your doctor.Tell your doctor if your condition persists or worsens.What conditions does Risperdal treat? If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare.
If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.What should I know regarding pregnancy, nursing and administering Risperdal to children or the elderly?
If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects.
You may report side effects to Health Canada at 1-866-234-2345.List Risperdal side effects by likelihood and severity.

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