Olanzapine (Oral)

Olanzapine is used to treat schizophrenia. It may also be used alone or with other medicines (for example, lithium or valproate) to treat mania or mixed episodes that are part of bipolar disorder (manic-depressive illness). Olanzapine may also be used together with fluoxetine to treat depression that is part of bipolar disorder, and depression in patients who have tried other antidepressants that did not work well. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

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

It is very important that your doctor checks your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Olanzapine may cause some people to feel agitated, irritable, or show other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to feel more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

This medicine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a rash, red, swollen skin, fever, chills, cough, trouble breathing, swollen glands, or unusual bleeding, bruising, or weakness after 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 or your child 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 happens, your doctor may give you or your child 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 or your child's weight regularly while using this medicine.

Check with your doctor right away if you have trouble breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, 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 or your child 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.

Dizziness, lightheadedness, or fainting may occur, especially when getting 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 or your child 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.

Olanzapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, 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 tasks that require you to be alert, well-coordinated, or able to think or see well.

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

This medicine may make it harder for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while exercising. Avoid very hot places. Call your doctor if you are too hot and cannot cool down.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of taking the drug must be weighed against the good it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. As well inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olanzapine in children. However, safety and efficacy of olanzapine alone in children younger than 13 years of age and olanzapine and fluoxetine combination in children younger than 10 years of age have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of olanzapine in the elderly. Nevertheless, elderly patients are more likely to have dementia or age-related liver, kidney, or heart issues, which may require caution or an adjustment in the dose for patients receiving olanzapine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this drug while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially essential that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medications is not recommended. Your clinician may decide not to treat you with this medication or change some of the other medications you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levoketoconazole
• Levomethadyl
• Metoclopramide
• Pimozide
• Piperaquine
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medication with any of the following drugs is normally not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Abametapir
• Acepromazine
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amobarbital
• Anagrelide
• Anileridine
• Apalutamide
• Apomorphine
• Apomorphine Hydrochloride
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Baclofen
• Bedaquiline
• Benperidol
• Benzhydrocodone
• Bromazepam
• Bromocriptine Mesylate
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butorphanol
• Cabergoline
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Enflurane
• Enoxacin
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etrasimod
• Famotidine
• Felbamate
• Fenoldopam Mesylate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levodopa
• Levofloxacin
• Levorphanol
• Lithium
• Lofexidine
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Mefloquine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methacholine
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nelfinavir
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Norfloxacin
• Octreotide
• Ofloxacin
• Omeprazole
• Ondansetron
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Pixantrone
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Pramipexole Dihydrochloride
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Ribociclib
• Rifampin
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Ropinirole Hydrochloride
• Rotigotine
• Scopolamine
• Secobarbital
• Secretin Human
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Tetrabenazine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this drug with any of the following medications may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Betel Nut
• Fosamprenavir
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you tell your doctor if you have any other medical issues, especially:

• Blood vessel disease or circulation issues or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—May cause side effects to become worse.

• Breast cancer, prolactin-dependent or
• Glaucoma, narrow-angle or
• Hyperlipidemia (high cholesterol or fat in the blood) or
• Hyperprolactinemia (high prolactin in the blood) or
• Liver disease or
• Paralytic ileus (severe intestinal issue), or history of or
• Prostatic hypertrophy (enlarged prostate), or history of or
• Seizures, history of or
• Urinary retention (issues with passing urine), or history of—Use with caution. This medicine may make these conditions worse.

• Diabetes or
• Hyperglycemia (high blood sugar)—Use with caution. This drug may raise blood sugar levels.

• Phenylketonuria (PKU, a genetic disease of metabolism)—The orally disintegrating tablet (Zyprexa® Zydis®) contains phenylalanine, which can make this condition worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require 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
• blurred vision
• change in vision
• change in walking and balance
• clumsiness or unsteadiness
• difficulty with speaking
• difficulty with swallowing
• drooling
• impaired vision
• inability to sit still
• loss of balance control
• mask-like face
• muscle trembling, jerking, or stiffness
• need to keep moving
• rapid weight gain
• restlessness
• shuffling walk
• slowed movements
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• trembling or shaking of the fingers, hands, feet, legs, or arms
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual weight gain or loss

Less common

• Bladder pain
• bloody or cloudy urine
• bruising
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• excessive muscle tone
• frequent urge to urinate
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• itching of the vagina or genital area
• lack of coordination
• large, flat, blue, or purplish patches in the skin
• loss of bladder control
• loss of memory
• lower back or side pain
• muscle tension or tightness
• nervousness
• pain during sexual intercourse
• pounding in the ears
• problems with memory
• rhythmic movement of the muscles
• slow, fast, pounding, or irregular heartbeat or pulse
• speaking is less clear than usual
• sticking out the tongue
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• twitching
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual or incomplete body or facial movements
• weakness of the arms and legs

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. 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

• Acid or sour stomach
• back pain
• belching
• change in personality
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• fever
• heartburn
• increased appetite
• increased cough
• indigestion
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• runny nose
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• thirst
• trouble sleeping
• trouble with concentrating
• watering of the mouth

Less common

• Blemishes on the skin
• body aches or pain
• chills
• cold sweats
• congestion
• cough
• dry skin
• dryness or soreness of the throat
• false or unusual sense of well-being
• heavy menstrual bleeding (periods)
• hoarseness
• joint pain
• lack of feeling or emotion
• leg cramps
• pain in the arms or legs
• pimples
• sweating
• tender, swollen glands in the neck
• uncaring feelings
• voice change
• vomiting

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.

In the U.S.

• ZyPREXA
• ZyPREXA Zydis

Available Dosage Forms:

• Tablet, Disintegrating
• Tablet

Therapeutic Class: Antipsychotic

Chemical Class: Thienobenzodiazepine

Take this medicine exactly as directed by your doctor. 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 the instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

If you are using the orally disintegrating tablet (Zyprexa® Zydis®), make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

You may take this medicine with or without food.

Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (orally disintegrating tablets, regular tablets): For treatment of schizophrenia: Adults—At first, 5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Children 13 to 17 years of age—At first, 2.5 or 5 mg once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Children younger than 13 years of age—Use and dose must be determined by your doctor. For treatment of mania or mixed episodes with bipolar disorder (olanzapine alone): Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Children 13 to 17 years of age—At first, 2.5 or 5 mg once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Children younger than 13 years of age—Use and dose must be determined by your doctor. For treatment of mania or mixed episodes with bipolar disorder (olanzapine with lithium or valproate): Adults—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Children—Use and dose must be determined by your doctor. For treatment of depression with bipolar disorder (olanzapine with fluoxetine): Adults—At first, 5 milligrams (mg) of olanzapine and 20 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 18 mg of olanzapine and 75 mg of fluoxetine per day. Children 10 to 17 years of age—At first, 2.5 milligrams (mg) of olanzapine and 20 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 12 mg of olanzapine and 50 mg of fluoxetine per day. Children younger than 10 years of age—Use and dose must be determined by your doctor. For treatment resistant depression (olanzapine with fluoxetine): Adults—At first, 5 milligrams (mg) of olanzapine and 20 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 18 mg of olanzapine and 75 mg of fluoxetine per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What drugs cause tardive dyskinesia?