Latuda is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Latuda is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Latuda is also used to treat episodes of depression associated with bipolar disorder (bipolar depression) in adults and children who are at least 10 years old.

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related psychosis.

Some young people have thoughts about suicide when taking Latuda. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before you take Latuda, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson's disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

Some medicines can interact with lurasidone and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

While you are taking Latuda, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Latuda may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of lurasidone. Stop using this medicine and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Take Latuda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Latuda should be taken with food (at least 350 calories).

You may need frequent blood tests.

It may take several weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using Latuda.

You should not stop using this medicine suddenly. Stopping suddenly may cause other problems.

It is easier to become dangerously overheated and dehydrated while you are taking Latuda. Drink plenty of fluids, especially in hot weather and during exercise. You may also be more sensitive to temperature extremes (hot or cold).

Store at room temperature away from moisture and heat.

You should not use Latuda if you are allergic to lurasidone.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lurasidone. Your doctor may change your treatment plan if you also use:

• antifungal medicine such as ketoconazole or voriconazole;

• an antibiotic such as clarithromycin or rifampin;

• an antiviral such as ritonavir;

• St. John's wort; or

• seizure medicine such as carbamazepine or phenytoin.

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.

Tell your doctor if you have ever had:

• heart disease or a stroke;

• high or low blood pressure;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes or high blood sugar (in you or your family);

• a seizure;

• liver or kidney disease;

• low white blood cell (WBC) counts;

• abnormal hormone function tests (thyroid, pituitary gland);

• breast cancer; or

• suicidal thoughts or actions.

Some people have thoughts about suicide while taking lurasidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking lurasidone without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lurasidone on the baby.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Latuda is not approved for schizophrenia in anyone younger than 13 years old. Latuda is not approved for depression in anyone younger than 10 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking Latuda.

Get emergency medical help if you have signs of an allergic reaction to Latuda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of Latuda can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use lurasidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• any new or unusual muscle movements you cannot control;

• a light-headed feeling, like you might pass out;

• a seizure (convulsions);

• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;

• (in men) breast swelling, impotence;

• trouble swallowing;

• manic episodes - racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;

• low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Latuda side effects may include:

• drowsiness;

• weight gain;

• tremors, muscle stiffness, slow muscle movement;

• feeling restless or being unable to sit still;

• nausea, vomiting;

• runny nose; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Latuda with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can interact with lurasidone, especially:

• depression or psychotic episodes;

• sleep problems (insomnia);

• high blood pressure or a heart rhythm disorder;

• swelling or inflammation;

• seizures; or

• Parkinson's disease.

This list is not complete and many other drugs may interact with lurasidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.