Olanzapine and samidorphan is a combination antipsychotic medicine that is used to treat schizophrenia in adults.

Olanzapine and samidorphan is also used to treat manic or mixed episodes in adults with bipolar I disorder. This medicine is sometimes used together with lithium or valproate to treat these conditions.

Olanzapine and samidorphan may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to olanzapine or samidorphan.

Do not take this medicine if you use opioid medication or you are going through withdrawal from opioid dependency. Opioids include oxycodone, morphine, hydrocodone, buprenorphine, fentanyl, and others.

Samidorphan can interact with opioid medication and cause a fatal overdose or severe opioid withdrawal that may need to be treated in a hospital.

Tell your doctor if you have used an opioid medication within the past 7 to 14 days. Be sure to tell your doctor the specific type of opioid medicine you used (such as controlled-release, extended-released, or transdermal skin patch).

Olanzapine and samidorphan may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems, a stroke, high or low blood pressure;
• low white blood cell counts;
• diabetes or high blood sugar (in you or a family member);
• high cholesterol or triglycerides;
• trouble swallowing;
• a seizure;
• an enlarged prostate and urination problems;
• breast cancer;
• high blood levels of prolactin;
• drug addiction;
• constipation, or a bowel obstruction;
• kidney disease; or
• if you have a planned surgery or medical procedure.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

It may be harder for you to get pregnant while you are using this medicine. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of olanzapine and samidorphan on the baby.

Olanzapine can pass into breast milk. If you are breastfeeding, tell your doctor if you notice severe drowsiness, irritability, feeding problems, tremors, or unusual muscle movements in the nursing baby.

Not approved for use by anyone younger than 18 years old.

Use Olanzapine And Samidorphan (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Long-term use of olanzapine and samidorphan can cause a serious movement disorder that may not be reversible. The longer you use olanzapine and samidorphan, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Samidorphan can make you more sensitive to the effects of opioid medicine, and you could have a fatal opioid overdose. If you use opioid medicine, a person caring for you should seek emergency medical attention if you have severe dizziness or drowsiness, confusion, slow breathing with long pauses, or if you are hard to wake up.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• trouble swallowing;
• a seizure;
• impotence, sexual problems, missed menstrual periods, breast swelling or discharge;
• low white blood cell counts--fever, chills, weakness, sore throat, cough, mouth sores, skin sores;
• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• high blood sugar--increased thirst, increased urination, 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 side effects may include:

• increased appetite, weight gain;
• dizziness, drowsiness, weakness;
• problems with speech or memory;
• tremor, numbness, tingling, burning pain;
• headache;
• dry mouth, upset stomach, constipation;
• back pain; or
• increased salivation.

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.

Avoid drinking alcohol.

It is easier to become dangerously overheated and dehydrated while you are taking this medicine. Avoid exercising too much, being in sunlight, or being outside in hot weather. Avoid wearing heavy clothing.

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