Does INVEGA® have side effects?

You may experience some side effects with INVEGA®. Not all people experience the same side effects.

The most common side effects observed in clinical trials for the treatment of schizoaffective disorder were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), heartburn, constipation, sleepiness, weight increase, and sore throat.

This is not a complete list of all possible side effects. Please see full Prescribing Information. Ask your doctor or treatment team if you have any questions, if you are taking INVEGA® and think you are experiencing any side effects or feel you are not getting better, or want more information.

Tell your doctor if you are taking prescription drugs, over-the-counter medicines, or herbal or dietary supplements. Your doctor will tell you if there are concerns with taking INVEGA® with your medicines.

Common safety questions about INVEGA®

Will INVEGA® make me feel sleepy?

Each person’s experience with INVEGA® is different. INVEGA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA®, be careful driving a car, operating machines, or doing things that require you to be alert.

Will INVEGA® make me gain weight?

Everyone responds differently to medicine, but weight gain has been reported in patients taking atypical antipsychotics. You and your doctor should monitor weight gain while on treatment. Make sure to talk to your doctor if you are concerned about weight gain.

For more information on side effects, please read the IMPORTANT SAFETY INFORMATION for INVEGA®.

What additional safety information do I need to know about INVEGA®?

INVEGA® (paliperidone) is used for the treatment of schizoaffective disorder in adults and for the treatment of schizophrenia in adults and in adolescents (12-17 years of age).

INVEGA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

Neuroleptic Malignant Syndrome (NMS) is a rare but serious side effect that could be fatal and has been reported with INVEGA® and similar medicines. Call your doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.

Tardive Dyskinesia (TD) is a rare but serious and sometimes permanent side effect reported with INVEGA® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your 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 total dose received. This condition can also develop after a short period of treatment at low doses, but this is less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.

One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

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 INVEGA® 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. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA®.

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

INVEGA® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

INVEGA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

INVEGA® 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.

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

INVEGA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA®, be careful driving a car, operating machines, or doing things that require you to be alert.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

INVEGA® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

Do not drink alcohol while you are taking INVEGA®.

The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes) and fast heartbeat, and in adolescents were: drowsiness, abnormal muscle movement (including restlessness, tremor shaking, involuntary muscle contractions, stiff muscles making your movements jerky), fast heartbeat, anxiety (nervousness), and in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.

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 INVEGA® 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.

Important Safety Information

 

INVEGA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA® is not for treating dementia-related psychosis.

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

Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive INVEGA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA® 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. Symptoms may go away partially or completely if therapy is stopped.

One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your healthcare professional about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your healthcare professional IMMEDIATELYif you feel faint or feel a change in the way that your heart beats (palpitations).

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 INVEGA® 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 healthcare professional 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 healthcare professional while on treatment.
  • Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.

INVEGA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA®.

Some people taking INVEGA® 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 may be reduced.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare provider for the potential risk of falls.

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

INVEGA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA® affects you.

INVEGA® 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.

INVEGA® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

INVEGA® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

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

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if INVEGA® will harm your unborn baby. If you become pregnant while taking INVEGA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961- 2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry Infants born to women who are treated with INVEGA ® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. INVEGA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA®.

INVEGA® may impair fertility, which is reversible. Speak to your healthcare professional if you plan to become pregnant.

The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes); feeling of inner restlessness or needing to be constantly moving; and fast heartbeat.

The most common side effects that occurred with INVEGA® in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.

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

If you have any questions about INVEGA® or your therapy, talk with your healthcare professional

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

Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA® and discuss any questions you have with your healthcare professional.

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