Lurasidone is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia. This medicine should not be used to treat behavioral problems in elderly patients who have dementia. It may be used alone or with other medicines (eg, lithium, valproate) to treat depression caused by bipolar disorder.

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

Take this medicine only as directed by your doctor even if you feel well. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You must take this medicine with food (containing at least 350 calories).

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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

Absence of or decrease in body movement

difficulty with swallowing

drooling

inability to sit still

incremental or ratchet-like movement of the muscle

loss of balance control

mask-like face

muscle discomfort

muscle trembling, jerking, or stiffness

need to keep moving

restlessness

rigid or stiff muscles

shakiness in the legs, arms, hands, or feet

shuffling walk

slow movements

slow reflexes

slurred speech

stiffness of the arms and legs

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

trembling or shaking of the hands or feet

twisting movements of the body

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

Less common

Arm, back, or jaw pain

blurred vision

burning while urinating

changes in patterns and rhythms of speech

chest pain or discomfort

chills

cold sweats

confusion

difficult or painful urination

difficulty opening the mouth

difficulty with breathing

dizziness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fixed position of the eye

headache

high fever

inability to move the eyes

inability to speak

increased blinking or spasms of the eyelid

increased sweating

lockjaw

loss of bladder control

muscle spasm, especially of the neck and back

nervousness

pale skin

pounding in the ears

seizures

severe muscle stiffness

severe or sudden headache

slow or fast heartbeat

slurred speech

sticking out of the tongue

sweating

temporary blindness

tiredness

trouble with breathing, speaking, or swallowing

troubled breathing with exertion

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

unusual bleeding or bruising

unusual facial expressions

unusual tiredness or weakness

unusually pale skin

weakness in the arm or leg on one side of the body, sudden and severe

Rare

Black, tarry stools

bloody urine

breast pain or swelling

cough

dark-colored urine

decreased frequency or amount of urine

fever

increased thirst

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

loss of appetite

lower back or side pain

muscle cramp, pain, or stiffness

nausea

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, fingers, or lower legs

swollen glands

vomiting

weight gain

Incidence not known

Decreased urine output

hives or welts, itching, skin rash

loss of consciousness

redness of the skin

swelling of the throat or tongue

tightness in the chest

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

Anxiety

belching

drowsiness

dry mouth

heartburn

hyperventilation

indigestion

irritability

relaxed and calm feeling

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

trouble sleeping

unusually deep sleep

unusually long duration of sleep

Less common

Abnormal dreams

back pain

blurred vision

burning feeling in the chest or stomach

decreased appetite

diarrhea

feeling of constant movement of self or surroundings

indigestion

sensation of spinning

sweating

tenderness in the stomach area

watering of mouth and drooling

Rare

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

unexpected or excess milk flow from the breasts

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 your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Lurasidone should not be used with certain medicines such as carbamazepine (Tegretol®), clarithromycin (Biaxin®), ketoconazole (Nizoral®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), St. John's wort, or voriconazole (Vfend®). Using these medicines together may cause serious unwanted effects. Make sure your doctor knows all of the medicines you are taking.

Lurasidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.

Check with your doctor right away if you 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 have 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 while you are using this medicine.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased 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.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Lurasidone 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 have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

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

This medicine may cause some people to become drowsy or dizzy, or to have trouble with thinking or 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.

Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.