Quetiapine Fumarate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat bipolar disorder, depression, or schizophrenia. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause uncontrolled muscle movements that may not go away even after you stop taking this medicine. This medicine may also cause other unwanted side effects. Older adults with dementia are at greater risk for side effects including death. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antipsychotic

Generic and brand names: quetiapine fumarate, oral; Seroquel; Seroquel XR

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of:

• Bipolar disorder
• Major depression
• Schizophrenia

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood or bone marrow disorder, or low white blood cell count
• A stroke or transient ischemic attack (TIA)
• Alzheimer's disease or dementia
• Breast cancer
• Cataracts
• Diabetes
• Heart disease, a heart attack, or heart failure
• High or low blood pressure
• High cholesterol or high triglycerides
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with low blood levels of potassium or magnesium
• Problems with dehydration
• Seizures
• Thoughts of suicide
• Thyroid problems
• Trouble swallowing

Females of childbearing age: Tell your healthcare provider if you are pregnant or become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while you are taking this medicine. Taking this medicine during the last 3 months of pregnancy may cause problems for the baby. Symptoms the baby may have include restlessness, tight muscles, floppy muscles, shaking, trouble breathing, or trouble feeding. Talk with your provider about this.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 10.

You will start taking a low dosage. Your dose will gradually be increased until you reach one that works well and causes as few side effects as possible. Follow your healthcare provider's directions exactly.

This medicine comes in regular tablets and extended-release tablets. Do not cut, crush, or chew the extended-release tablets. Swallow them whole. Take the extended-release tablets without food or with a light meal. The extended-release tablets are usually taken once a day. Ask your pharmacist if you have the extended-release tablets.

If you have the regular tablets, you may take them with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness, fast heartbeat, lightheadedness, fainting, trouble walking, slurred speech, seizures.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions, especially in some children, teenagers, and young adults. This may happen within the first few months of treatment or when the dose changes. Call your healthcare provider right away if you notice: new or increased thoughts of suicide, or changes in mood or behavior such as becoming depressed, irritable, or anxious.

Older adults with dementia are at greater risk for side effects including death. Talk with your provider about this.

Newborn babies may have trouble breathing or feeding, or other symptoms, if the mother takes this medicine in the last 3 months of pregnancy. This medicine should be used during pregnancy only if the benefit is greater than the possible risk to your baby. Talk with your healthcare provider about this.

This medicine may increase blood pressure, especially in children. Talk with your healthcare provider about this.

When you start taking this medicine, you may feel dizzy and faint when you get up too fast from sitting or lying down. This may happen during the first 3 to 5 days you take this medicine or when your dosage is increased. Getting up slowly may help.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movement. This may happen even after you stop taking the medicine. Talk to your healthcare provider about this.

You will need blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may also cause you to gain weight. Talk with your healthcare provider about this.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or be confused. Contact your provider right away if you have these symptoms.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery until you are fully alert. Also, do not drink alcohol while you are taking this medicine because it may increase these side effects. Ask your healthcare provider about this.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

You need to have regular eye exams while on this medicine because it may cause cataracts.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of developing diabetes, especially if you are overweight or have a family history of diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Seizures, tremors, fast or irregular heartbeat, slow heartbeat, heavy sweating, high or unexplained fever, muscle stiffness or pain, confusion, feeling as if you need to be moving constantly, muscle spasms, twitching, uncontrolled movements, severe dizziness or fainting, thoughts of suicide, unusual mood or behavior changes, new or worsening depression, increased urination, increased thirst, extreme hunger, cough, sore throat, trouble swallowing, severe or ongoing trouble sleeping, severe or ongoing nausea or vomiting, vision changes.

Other: Headache, drowsiness, mild dizziness, constipation, dry mouth, nausea, weight gain, increased appetite, joint pain, lightheadedness, stuffy or runny nose, change in sexual ability or desire, breast enlargement, change in menstrual periods.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Anagrelide (Agrylin)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, diazepam (Valium), and lorazepam (Ativan)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Anticholinergic medicines such as benztropine (Cogentin), dicyclomine (Bentyl), glycopyrrolate (Cuvposa, Robinul), hyoscyamine (HyoMax, Levbid, Levsin), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Bladder control medicines such as oxybutynin (Ditropan XL, Oxytrol) and tolterodine (Detrol)
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), degarelix (Firmagon), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris), cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, quinidine, and ranolazine (Ranexa)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and famotidine (Pepcid)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and vilanterol (Breo Ellipta)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as echinacea, gotu kola, kava, SAMe, St. John's wort, tryptophan, and valerian
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Pain medicines such as buprenorphine (Buprenex, Butrans), codeine, hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as apomorphine (Apokyn), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), and ropinirole (Requip)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rivastigmine (Exelon)
• Sleeping pills such as butabarbital (Butisol), flurazepam, pentobarbital (Nembutal), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.