Paliperidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may also be used alone or together with other medicines to treat patients with schizoaffective disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Swallow the extended-release tablet whole with a liquid (water or juice). Do not crush, break, or chew it.

Part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and is nothing to worry about.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty with speaking

drooling

fast, pounding, or irregular heartbeat or pulse

increase in body movements

loss of balance control

muscle trembling, jerking, or stiffness

shuffling walk

stiffness of the limbs

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

Less common

Chest pain

cold sweats

confusion

cough

difficulty with swallowing

dizziness

excessive muscle tone

fainting

inability to move the eyes

increased blinking or spasms of the eyelid

increased blood pressure

mask-like face

muscle tension or tightness

pain in the arms or legs

slow heartbeat

slowed movements

slurred speech

sticking out of the tongue when not meaning to

tic-like (jerky) movements of the head, face, mouth, and neck

trembling and shaking of the fingers and hands

tremors

trouble with breathing, speaking, or swallowing

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

unusual tiredness or weakness

Incidence not known

Decrease in the frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lip smacking or puckering

painful or prolonged erection of the penis

painful urination

puffing of cheeks

rapid or worm-like movements of the tongue

severe constipation

severe vomiting

stomach pain

uncontrolled chewing movements

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Absent, missed, or irregular menstrual periods

difficulty having a bowel movement

fear or nervousness

headache

inability to sit still

nausea

need to keep moving

sleepiness or unusual drowsiness

stopping of menstrual bleeding

vomiting

weight gain

Less common

Back pain

belching

blurred vision

changes in appetite

dry mouth

fever

heartburn

indigestion

lack or loss of strength

muscle aches

sore throat

stomach discomfort or upset

stuffy or runny nose

swelling or soreness of the breasts in both females and males

swollen tongue

unexpected or excess milk flow from breasts

upper stomach pain

Incidence not known

Sleepwalking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may raise your risk of having a stroke. This is more likely in people who already have heart or blood vessel disease. Check with your doctor right away if you are having confusion, difficulty in speaking, slow speech, inability to speak or move the arms, legs, or facial muscles, double vision, or headache.

Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you or your child have increased thirst or urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you or your child have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

Paliperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may make it more difficult for your body to cool itself down.Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are using paliperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your or your child's weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.