Generic Name: olanzapine/fluoxetine (oh-LAN-za-peen/floo-OX-e-teen)
Brand Name: Symbyax

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Symbyax outweigh the risks.

Families and caregivers must closely watch patients who take Symbyax. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Symbyax contains an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Symbyax is not approved to treat mental problems caused by dementia.

Symbyax is not approved for use in all children. If Symbyax is prescribed for your child, talk with the doctor to be sure that Symbyax is right for your child.


Symbyax is used for:

Treating depression in patients with bipolar disorder. It is also used to treat depression in patients who have not responded to 2 other medicines. It may also be used for other conditions as determined by your doctor.

Symbyax is a combination of an atypical antipsychotic and a selective serotonin reuptake inhibitor (SSRI). It works by affecting certain substances in the brain, including serotonin. This helps to improve certain mood problems.

Do NOT use Symbyax if:

  • you are allergic to any ingredient in Symbyax
  • you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or St. John's wort within the last 14 days
  • you are taking clopidogrel, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), sibutramine, another SSRI (eg, paroxetine), thioridazine, or tryptophan
  • you are taking another medicine that contains olanzapine or fluoxetine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Symbyax:

Some medical conditions may interact with Symbyax. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
  • if you have a history of seizures, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), abnormal electrocardiogram (ECG), a heart attack, stroke or "mini-stroke," blood vessel problems, high blood cholesterol or triglyceride levels, high or low blood pressure, or low white blood cell levels
  • if you have a family history of QT prolongation or sudden death due to heart problems
  • if you have a history of liver problems (eg, cirrhosis); severe kidney problems; stomach or bowel problems (eg, bleeding, blockage, paralytic ileus); bleeding problems; enlarged prostate; narrow-angle glaucoma or a risk of developing it; neuroleptic malignant syndrome (NMS); prolonged, painful erection; or metabolism problems
  • if you have diabetes or high blood sugar, are very overweight, or if a family member has had diabetes
  • if you are dehydrated or have low blood volume, low blood sodium levels, Alzheimer disease, dementia, or trouble swallowing
  • if you drink alcohol, smoke, or will be exposed to high temperatures
  • if you have a history of high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer
  • if you will be having electroconvulsive therapy (ECT)
  • if you are taking a medicine that contains methylene blue

Some MEDICINES MAY INTERACT with Symbyax. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for anxiety, other mental or mood problems, aches and pains, allergies, appetite suppression, blood thinning, cancer, cough, heart problems, heartburn, high blood pressure, high cholesterol, HIV, infections, inflammation, irregular heartbeat, migraine headaches, muscle relaxers, Parkinson disease, seizures, ulcers), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Symbyax. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Symbyax.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Symbyax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Symbyax:

Use Symbyax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Symbyax comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Symbyax refilled.
  • Take Symbyax by mouth on an empty stomach or with food.
  • Take Symbyax in the evening, unless your doctor tells you otherwise.
  • Continue to take Symbyax even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Symbyax without checking with your doctor. Side effects may occur. They may include mental or mood changes, agitation, anxiety, irritability, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Symbyax and whenever a change in dose is made.
  • If you miss a dose of Symbyax, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Symbyax.

Important safety information:

  • Symbyax may cause drowsiness, dizziness, or blurred vision. It may also cause you to not be able to make decisions, think clearly, or react quickly. Do not drive or perform other possibly unsafe tasks until you know how you react to Symbyax.
  • Do not drink alcohol while you are taking Symbyax.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Symbyax; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Symbyax may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you think you may be dehydrated.
  • Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Symbyax for longer than prescribed without checking with your doctor.
  • Children and teenagers who take Symbyax may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Symbyax closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Symbyax may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Symbyax may raise your blood sugar. High blood sugar may make you feel confused, drowsy, hungry, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Symbyax may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Symbyax may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • NMS is a possibly fatal syndrome that can be caused by Symbyax. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take Symbyax may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Symbyax in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Symbyax.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Symbyax. Your risk may be greater if you take Symbyax with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • If your doctor tells you to stop taking Symbyax, you will need to wait at least 5 weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Symbyax.
  • Low blood sodium levels may occur from treatment with Symbyax. In severe cases, this can be deadly. Call your doctor right away if you have confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, or weakness.
  • Some patients have experienced weight gain while using Symbyax. You may need to have regular weight checks while you use Symbyax.
  • Lab tests, including fasting blood glucose, cholesterol and triglyceride levels, complete blood cell counts, electrocardiograms (ECGs), and liver function, may be performed while you use Symbyax. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Symbyax with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Symbyax should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
  • Symbyax may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Symbyax.
  • PREGNANCY and BREAST-FEEDING: Symbyax may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Symbyax while you are pregnant. Symbyax is found in breast milk. Do not breast-feed while taking Symbyax.

Possible side effects of Symbyax:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased appetite; sore throat; tiredness; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, bloody, or tarry stools; chest pain; confusion; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; joint pain; memory loss; new or worsening mental, mood, or behavior changes (eg, agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well being, restlessness, inability to sit still); red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, headache, or trouble sleeping; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of dehydration (eg, decreased sweating or urination, severe or persistent dry mouth, feeling very hot or thirsty); symptoms of high prolactin levels (eg, enlarged breast size, decreased sexual ability, missed menstrual period, nipple discharge); symptoms of stroke (eg, one-sided weakness, slurred speech); tremor; trouble concentrating, speaking, swallowing, or walking; trouble urinating; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising or bleeding; unusual weakness; vision changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Symbyax:

Store Symbyax between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Symbyax out of the reach of children and away from pets.

General information:

  • If you have any questions about Symbyax, please talk with your doctor, pharmacist, or other health care provider.
  • Symbyax is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Symbyax or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Symbyax. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Symbyax. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Symbyax.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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