The most common side effects that may occur with Risperdal, in the treatment of bipolar mania either alone or in combination with a mood stabilizer (Valproate or Lithium) are: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence. Common side effects that may occur with Risperdal treatment of schizophrenia are: anxiety, sleepiness, restlessness, tremors, muscle stiffness, dizziness, constipation, nausea, indigestion, runny nose, rash, and rapid heart beat.
In addition to the less serious Risperdal side effects experts have found that Risperdal may also include serious side effects including:
Diabetes
Diabetic Coma
Hyperglycemia
Ketoacidosis
Neuroleptic Malignant Syndrome
Pancreatitis
Stroke
Tardive Diskinesia *
Weight Gain
Death
* Tardive dyskinesia is a lifelong condition with no known effective treatment that has been shown to occur among atypical antipsychotic medication users. Only if identified in early stages can tardive dyskinesia sometimes be reversed. Older patients and women are at an especially high risk for suffering Risperdal side effects like tardive dyskinesia.
2006-08-02 08:36:20
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answer #1
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answered by Anonymous
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I have a friend, Ira, who has been taking Risperdal and he's gained at least 30 lbs. He doesn't "blow up for no reason" but his moods fluctuate from energized and sociable to silent and isolated. I'll ask him if he's noticed anything else and get back to you...
2006-08-04 04:36:11
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answer #2
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answered by Janet Planet 1
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RISPERDAL®
~Orthostatic Hypotension ~
RISPERDAL® (risperidone) 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. Syncope was reported in 0.2% (6/2607) of RISPERDAL®-treated patients in Phase 2 and 3 studies. The risk of orthostatic hypotension and syncope may be minimized by limiting the initial dose to 2 mg total (either QD or 1 mg BID) in normal adults and 0.5 mg BID in the elderly and patients with renal or hepatic impairment (see DOSAGE AND ADMINISTRATION). Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. A dose reduction should be considered if hypotension occurs. RISPERDAL® should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia. Clinically significant hypotension has been observed with concomitant use of RISPERDAL® and antihypertensive medication.
~Seizures~
During premarketing testing, seizures occurred in 0.3% (9/2607) of RISPERDAL®-treated patients, two in association with hyponatremia. RISPERDAL® should be used cautiously in patients with a history of seizures. Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. RISPERDAL® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
~Hyperprolactinemia ~
As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. 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. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. As is common with compounds which increase prolactin release, an increase in pituitary gland, mammary gland, and pancreatic islet cell hyperplasia and/or neoplasia was observed in the risperidone carcinogenicity studies conducted in mice and rats (see PRECAUTIONS – Carcinogenesis, Mutagenesis, Impairment of Fertility). However, 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.
~Potential for Cognitive and Motor Impairment ~Somnolence was a commonly reported adverse event associated with RISPERDAL® treatment, especially when ascertained by direct questioning of patients. This adverse event is dose-related, and in a study utilizing a checklist to detect adverse events, 41% of the high-dose patients (RISPERDAL® 16 mg/day) reported somnolence compared to 16% of placebo patients. Direct questioning is more sensitive for detecting adverse events than spontaneous reporting, by which 8% of RISPERDAL® 16 mg/day patients and 1% of placebo patients reported somnolence as an adverse event. Since RISPERDAL® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL® therapy does not affect them adversely.
~Priapism ~
Rare cases of priapism have been reported. While the relationship of the events to RISPERDAL® use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that RISPERDAL® may share this capacity. Severe priapism may require surgical intervention.
~Thrombotic Thrombocytopenic Purpura (TTP) ~A single case of TTP was reported in a 28 year-old female patient receiving RISPERDAL® in a large, open premarketing experience (approximately 1300 patients). She experienced jaundice, fever, and bruising, but eventually recovered after receiving plasmapheresis. The relationship to RISPERDAL® therapy is unknown.
~Antiemetic Effect ~
Risperidone has an antiemetic effect in animals; this effect may also occur in humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumor.
~Body Temperature Regulation~
Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral RISPERDAL® use. Caution is advised when prescribing for patients who will be exposed to temperature extremes.
~Suicide ~
The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for RISPERDAL® should be written for the smallest quantity of tablets, consistent with good patient management, in order to reduce the risk of overdose. Use in Patients With Concomitant Illness Clinical experience with RISPERDAL® in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using RISPERDAL® in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
RISPERDAL® has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing. Increased plasma concentrations of risperidone and 9-hydroxyrisperidone occur in patients with severe renal impairment (creatinine clearance <30 mL/min/1.73 m2), and an increase in the free fraction of risperidone is seen in patients with severe hepatic impairment. A lower starting dose should be used in such patients (see DOSAGE AND ADMINISTRATION).
*~*INFORMATION FOR PATIENTS~*~
Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL®:
~Orthostatic Hypotension~
Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration.
~Interference With Cognitive and Motor Performance~Since RISPERDAL® has the potential toimpair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL® therapy does not affect them adversely.
~Pregnancy~
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
~Nursing ~
Patients should be advised not to breast-feed an infant if they are taking RISPERDAL®.
~Concomitant Medication~
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.
~Alcohol~
Patients should be advised to avoid alcohol while taking RISPERDAL®.
~Phenylketonurics~
Phenylalanine is a component of aspartame. Each 2 mg RISPERDAL® M-TAB⢠Orally Disintegrating Tablet contains 0.56 mg phenylalanine; each 1 mg RISPERDAL® M-TAB⢠Orally Disintegrating Tablet contains 0.28 mg phenylalanine; and each 0.5 mg RISPERDAL® M-TAB⢠Orally Disintegrating Tablet contains 0.14 mg phenylalanine.
2006-08-02 19:45:56
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answer #5
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answered by breezy b 3
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