Olanzapine and fluoxetine combination is used to treat depression that is a part of bipolar disorder, and depression in patients who received other antidepressants that did not work well. Olanzapine and fluoxetine work by increasing the activity of certain chemicals called serotonin, norepinephrine, and dopamine in the brain. These chemicals help relieve the symptoms of depression. Olanzapine is an antipsychotic agent. Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs).

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

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

You may take this medicine with or without food.

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

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

confusion

congestion

cough

delusions

dementia

dryness or soreness of the throat

fever

hoarseness

rapid weight gain

runny nose

shakiness in the legs, arms, hands, or feet

tender, swollen glands in the neck

tingling of the hands or feet

trembling or shaking of the hands or feet

trouble with swallowing

unusual weight gain or loss

voice changes

Less common

Blurred vision

change in personality

change in vision

difficult or labored breathing

difficulty with sleeping

difficulty with speaking

dizziness

ear pain

headache

impaired vision

increase in body movements

loss of memory

nervousness

pounding in the ears

problems with memory

slow, fast, pounding, or irregular heartbeat or pulse

tightness in the chest

Rare

Inability to move the eyes

increased blinking or spasms of the eyelid

sticking out of the tongue

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

unusual facial expressions

Incidence not known

Bloody or black, tarry stools

constipation

severe stomach pain

vomiting of blood or material that looks like coffee grounds

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

Diarrhea

dry mouth

increased appetite

lack or loss of strength

weight gain

Less common

Change or problem with discharge of semen

decreased interest in sexual intercourse

difficulty with moving

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

muscle pain or stiffness

not able to have an orgasm

pain, swelling, or redness in the joints

tooth disorder

twitching

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 this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take this medicine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking this medicine during the 2 weeks after you stop a MAO inhibitor and wait 5 weeks after stopping this medicine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take thioridazine (Mellaril®) with this medicine, and wait 5 weeks after stopping this medicine before you start taking thioridazine. Do not use pimozide (Orap®) with this medicine. Using these medicines together can cause very serious heart problems.

This medicine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use this medicine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Olanzapine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Tell your doctor if you have the following symptoms: a rash, swollen, red skin, a fever, swollen, painful, or tender lymph glands in neck, armpit, or groin, trouble breathing, or yellow skin or eyes.

Check with your doctor right away if you are having convulsions, difficulty with breathing, fast heartbeat, 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 increase the amount of sugar in your blood. Check with your doctor right away if you 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.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

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

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you 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 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 immediately 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 increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

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.

Contact your doctor right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have ever had a heart rhythm problem, such as QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

This medicine may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Do not suddenly stop taking this medicine without first checking with your doctor. If you have been instructed to stop taking this medicine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

The use of alcohol is not recommended in patients who are using 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.