RISPERDAL® CONSTA® (risperidone) is approved for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.

FAQs – Treating With RISPERDAL® CONSTA®

FAQs: Treating With RISPERDAL® CONSTA®

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RISPERDAL® CONSTA® is given as an injection by a healthcare professional every 2 weeks. You will receive the injection in either the upper part of your buttock (gluteus) or in the upper arm (deltoid). You may be given a choice in where you receive your injection. Be sure to discuss it with your doctor.

If you cannot make it to your doctor’s office, there may be alternate locations where RISPERDAL® CONSTA® can be administered. Talk to your Treatment Team about alternate location options.

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A long-acting medicine by injection may cause some discomfort. However, the experience varies from person to person, as everyone handles pain differently. In a clinical trial, patients taking RISPERDAL® CONSTA® reported little pain at the site of injection, which decreased over time. In another study, where patients received RISPERDAL® CONSTA® in the deltoid muscle, no patient discontinued treatment due to injection site pain or reaction.

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You may be able to get your injection at a number of locations—at your doctor’s office or at select pharmacies, outpatient clinics, and urgent care centers. Ask your healthcare professional about your options.

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In a study of people taking RISPERDAL® CONSTA®, the most common side effects in the treatment of schizophrenia were headache, slow movements, with tremor, stiffness and a shuffling walk, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs and dry mouth. This is not a complete list of all possible side effects. Please see Important Safety Information for the full list. If you think you are experiencing a side effect while taking RISPERDAL® CONSTA® or have questions about your therapy, always speak with your doctor.

 

IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®

RISPERDAL® CONSTA® (risperidone) is approved for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.

Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.

Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL® CONSTA®.

RISPERDAL® CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL® CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long-lasting erections have been reported with the use of RISPERDAL® CONSTA®. Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL® CONSTA®. Caution should be used when administering RISPERDAL® CONSTA® to a nursing woman.

RISPERDAL® CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL® CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL® CONSTA®.

In a study of people taking RISPERDAL® CONSTA®, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

If you have any questions about RISPERDAL® CONSTA® or your therapy, talk with your doctor.

For more information about RISPERDAL® CONSTA®, please read the Important Product Information

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No. Taking RISPERDAL® CONSTA® does not mean that you are sicker in any way. All it means is that you have a different way to take the medicine that can help you manage your schizophrenia.

Medicines such as RISPERDAL® CONSTA® help healthcare professionals offer you more treatment choices. The decision to switch to RISPERDAL® CONSTA® means that your Treatment Team is looking for new ways to continue helping you manage your symptoms.

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If you have any questions about RISPERDAL® CONSTA®, talk with your doctor or Treatment Team. Please see the Important Product Information.

You can also call the Janssen toll-free number at 1-800-JANSSEN (1-800-526-7736) Monday-Friday, 9am-8pm, ET and Saturday-Sunday, 9am-5pm, ET, for more information about RISPERDAL® CONSTA ®.

 

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IMPORTANT SAFETY INFORMATION and INDICATION

RISPERDAL CONSTA® (risperidone) is approved for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA®

Do not receive RISPERDAL CONSTA® if you are allergic to paliperidone, risperidone, or any of the ingredients in RISPERDAL CONSTA®.

Neuroleptic, Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

High blood sugar and diabetes have been reported with RISPERDAL CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.

Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.

Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

RISPERDAL CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL CONSTA®.

RISPERDAL CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long-lasting erections have been reported with the use of RISPERDAL CONSTA®. Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL CONSTA®. Caution should be used when administering RISPERDAL CONSTA® to a nursing woman.

RISPERDAL CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL CONSTA®.

In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of schizophrenia were headache, slow movements (including tremor [shaking], stiffness, and a shuffling walk), dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and slow movements (including with tremor [shaking], stiffness, and a shuffling walk) and tremor (when used with lithium or valproate).

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about RISPERDAL CONSTA® or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information including Boxed WARNING for RISPERDAL CONSTA®.

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