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Patient Information Sheet
Risperidone Tablets (marketed as Risperdal)
This is a summary of the most important information about Risperdal.
For details, talk to your healthcare professional.
What is Risperdal?
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Risperdal is in a class of medications called
atypical antipsychotics. Antipsychotic medicines are used to treat
symptoms of schizophrenia that may include hearing voices, seeing
things, or sensing things that are not there, mistaken beliefs or
unusual suspiciousness.
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Risperdal may be used alone or with lithium or
divalproex for short-term treatment of mixed or manic episodes in
adults who have a condition called Bipolar I disorder. Bipolar
disorder is a mental illness that causes extreme mood swings.
What are The Risks?
The following are the risks and potential side effects of
Risperdal therapy. However, this list is not complete.
- Increased chance of death in elderly persons.
Elderly patients treated with atypical antipsychotics, such as
Risperdal, for dementia had a higher chance for death than
patients who did not take the medicine. Risperdal is not approved
for dementia.
- A life-threatening nervous system problem called
neuroleptic malignant syndrome (NMS). NMS can cause a high
fever, stiff muscles, sweating, a fast or irregular heart beat,
change in blood pressure, and confusion. NMS can affect your
kidneys. NMS is a medical emergency. Call your healthcare
professional right away if you experience these symptoms.
- A movement problem called tardive dyskinesia (TD).
Call your healthcare professional right away if you get muscle
movements that cannot be stopped.
- High blood sugar and diabetes. Patients with
diabetes or who have a higher chance for diabetes should have
their blood sugar checked often.
- Strokes have happened in older patients treated
for mental illness from dementia. Risperdal is not approved for
this use.
- Other serious side effects may include low blood
pressure seen as dizziness, increased heart beat and possibly
fainting, seizures, persistent erection, thrombotic
thrombocytopenic purpura (seen as fever and bruising), increase or
decrease in body temperature, and difficulty swallowing.
- The most common side effects include anxiety,
uncontrolled movements, constipation, nausea, upset stomach, runny
nose, rash, vision changes, saliva increase, abdominal pain,
inability to control urination, weight gain.
What Should I Tell My Healthcare
Professional?
Before you start taking Risperdal, tell your
healthcare professional if you:
- have or had heart problems
- have or have had seizures.
- have or had diabetes or increased blood sugar
- have or had liver disease
- have an obstruction of your intestines
- have Reye’s syndrome
- have a brain tumor
- are trying to become pregnant, are already pregnant,
or are breast-feeding.
- drink alcohol
- have a condition called phenylketonuria
Are There Any Interactions With
Drugs or Foods?
Because certain other medications can interact with
Risperdal, review all medications that you are taking with your
healthcare professional, including those that you take without a
prescription.
Your healthcare professional may have to adjust your
dose or watch you more closely if you take the following
medications:
- blood pressure medicines
- levodopa and medicines called dopamine agonists
- clozapine
- carbamazepine
- phenytoin
- rifampin
- phenobarbital
- fluoxetine and paroxetine
Avoid drinking alcohol while taking Risperdal.
Is There Anything Else I Need to
Know?
- Dizziness, and sometimes fainting, caused by a drop
in blood pressure may happen with Risperdal, especially when you
first start taking this medicine or when the dose is increased.
- Risperdal may impair judgment, thinking, or motor
skills. You should be careful in operating machinery, including
automobiles, until you know how Risperdal affects you.
- It is important to avoid overheating and dehydration
while taking Risperdal. Risperdal may make it harder to lower your
body temperature.
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
Druginfo@fda.hhs.gov
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Date created: April 2005, updated September 6, 2006 |
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