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
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
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
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
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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