Risperdal (Risperidone) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Risperdal

Bipolar Disorder »

What is bipolar disorder?

Bipolar disorder, also called manic depression, is a mental illness that is characterized by severe mood swings, repeated episodes of depression, and at least one episode of mania. Bipolar disorder is one kind of mood disorder that afflicts more than 1% of adults in the United States, up to as many as 4 million people. Here are some additional statistics about bipolar disorder:

Bipolar disorder is the fifth leading cause of disability worldwide.
Bipolar disorder is the ninth leading cause of years lost to death or disability worldwide.
The number of individuals with bipolar disorder who commit suicide is 60 times higher than that of the general population.
People who have bipolar disorder are at a higher risk of also suffering from substance abuse and other mental health problems.
Males may develop bipolar disorder earlier in life compared to females.
Blacks are sometimes dia...

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Risperdal

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RISPERDAL®
(risperidone) Tablets

RISPERDAL®
(risperidone) Oral Solution

RISPERDAL® M-TAB®
(risperidone) Orally Disintegrating Tablets

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. 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. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

RISPERDAL® contains risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-l,2-benzisoxazol-3-yl)-l-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[l,2-a]pyrimidin-4-one. Its molecular formula is C₂₃H₂₇FN₄O₂ and its molecular weight is 410.49. The structural formula is:

RISPERDAL®
(risperidone) Structural Formula Illustration

Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HC1.

RISPERDAL® Tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.

RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water.

RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.

What are the possible side effects of risperidone (Risperdal, Risperdal M-Tab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using risperidone and call your doctor at once if you have any of these serious side effects:

fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
fever, chills, body aches, flu symptoms;

Read All Potential Side Effects and See Pictures of Risperdal »

What are the precautions when taking risperidone (Risperdal)?

Before taking risperidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, low blood pressure, seizures, Parkinson's disease, memory problems (dementia), difficulty swallowing (especially in patients with dementia or Alzheimer's disease), strokes (cerebrovascular disease), dehydration, breast cancer, low white blood cell count.

(See also Side Effects section.) Also tell your doctor or pharmacist if either you or a family member has a history of the following:...

Read All Potential Precautions of Risperdal »

Last reviewed on RxList: 7/25/2011
This monograph has been modified to include the generic and brand name in many instances.