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What is Seroquel?

Seroquel (quetiapine) is an antipsychotic medicine. It works by changing the actions of chemicals in the brain.

Seroquel is used to treat schizophrenia in adults and children who are at least 13 years old.

Seroquel is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old. It is also used together with antidepressant medications to treat major depressive disorder in adults.

Extended-release quetiapine (Seroquel XR) is for use only in adults and should not be given to anyone younger than 18 years old.

Important information about Seroquel

Never take Seroquel in larger amounts, or for longer than recommended by your doctor. High doses or long-term use can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Seroquel is not for use in psychotic conditions related to dementia. It may cause heart failure, stroke, sudden death, or pneumonia in older adults with dementia-related conditions.

Stop using Seroquel and call your doctor at once if you have the following symptoms: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, uncontrolled muscle movements, feeling light-headed, blurred vision, eye pain, increased thirst and urination, excessive hunger, fruity breath odor, weakness, nausea and vomiting.

Some young people have thoughts about suicide when first taking Seroquel. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Before taking Seroquel

Seroquel is not for use in psychotic conditions related to dementia. Seroquel may cause heart failure, stroke, sudden death, or pneumonia in older adults with dementia-related conditions.

To make sure Seroquel is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • heart disease, heart rhythm problems, a history of heart attack or stroke;

  • high or low blood pressure;

  • a history of low white blood cell (WBC) counts;

  • abnormal thyroid tests or prolactin levels;

  • seizures or epilepsy;

  • cataracts;

  • high cholesterol or triglycerides;

  • a personal or family history of diabetes; or

  • trouble swallowing.

Some young people have thoughts about suicide when first taking Seroquel. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether Seroquel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Seroquel, do not stop taking it without your doctor's advice.

Quetiapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

Do not give Seroquel to a child without a doctor's advice. Extended-release quetiapine (Seroquel XR) is for use only in adults and should not be given to anyone younger than 18 years old.

How should I take Seroquel?

Never take Seroquel in larger amounts, or for longer than recommended by your doctor. Follow all directions on your prescription label. High doses or long-term use can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Take this medicine with a full glass of water. You may take Seroquel with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Seroquel may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking this medicine.

You should not stop using Seroquel suddenly. Stopping suddenly may make your condition worse.

Blood pressure may need to be checked often in a child or teenager taking this medicine.

This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Seroquel.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of quetiapine can be fatal.

What should I avoid while taking Seroquel?

Seroquel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke.

Avoid drinking alcohol. It can increase certain side effects of Seroquel.

Seroquel side effects

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • mask-like appearance of the face, trouble swallowing, problems with speech;

  • breast swelling or discharge (in men or women), missed menstrual periods, impotence, loss of libido;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  • sudden weakness or ill feeling, fever, chills, cold or flu symptoms, cough, sore throat, red or swollen gums, painful mouth sores, skin sores, trouble breathing.

Common Seroquel side effects may include:

  • dizziness, drowsiness, loss of energy, tired feeling;

  • increased appetite, weight gain;

  • dry mouth; or

  • nausea, vomiting, stomach pain or discomfort, constipation.

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.

What other drugs will affect Seroquel?

Taking Seroquel with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Seroquel with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with quetiapine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment, especially:

  • lumefantrine, metoclopramide, mifepristone;

  • a dye that is injected into your veins for an x-ray or CT scan;

  • cancer medicine--arsenic trioxide, bexarotene, nilotinib, toremifene, vandetanib, vemurafenib; heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, sotalol; HIV/AIDS medication--ritonavir, saquinavir; medicine to treat mental illness--iloperidone, pimozide, thioridazine, ziprasidone.

This list is not complete and many other drugs can interact with quetiapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

For the Consumer

Applies to quetiapine: oral tablet, oral tablet extended release

Along with its needed effects, quetiapine (the active ingredient contained in Seroquel) 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 while taking quetiapine:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sleepiness or unusual drowsiness
Less common
  • Black, tarry stools
  • blurred vision
  • changes in patterns and rhythms of speech
  • chest pain
  • cough
  • difficulty with swallowing
  • drooling
  • fever, muscle aches, or sore throat
  • inability to move the eyes
  • inability to sit still
  • increased blinking or spasms of the eyelid
  • lip smacking or puckering
  • loss of balance control
  • mask-like face
  • need to keep moving
  • painful or difficult urination
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • shuffling walk
  • slowed movements
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • sticking out of the tongue
  • stiffness of the arms or legs
  • sweating
  • swelling of the face, arms, hands, feet, or lower legs
  • swollen glands
  • trembling and shaking of the hands and fingers
  • trouble with breathing, speaking, or swallowing
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
Rare
  • Dry, puffy skin
  • fast, pounding, or irregular heartbeat
  • loss of appetite
  • menstrual changes
  • tiredness
  • unusual secretion of milk (in females)
  • weight gain
Incidence not known
  • Aching or discomfort in the lower legs or sensation of crawling in the legs
  • hives
  • itching
  • painful or prolonged erection of the penis
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • tightness in the chest
  • tingling of the hands or feet
  • unusual weight gain or loss
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking quetiapine:

Symptoms of overdose
  • Convulsions (seizures)
  • decreased urine
  • dry mouth
  • increased thirst
  • low blood pressure
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • weakness

Some side effects of quetiapine 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
  • Constipation
  • headache
Less common
  • Abnormal vision
  • acid or sour stomach
  • belching
  • decreased appetite
  • decreased strength and energy
  • headache
  • heartburn
  • increased appetite
  • increased muscle tone
  • increased sweating
  • increased weight
  • indigestion
  • sneezing
  • stomach discomfort, upset, or pain
  • stuffy or runny nose

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Applies to quetiapine: oral tablet, oral tablet extended release

Nervous system

Lower (worse) baseline scores predicted greater cognitive improvement. Change In cognitive performance was weakly related to change in symptom scores.

Nervous system side effects have included agitation (20%), somnolence (18%), dizziness (11%), tremor (8%), and anxiety (4%). Hypertonia, dysarthria, abnormal dreams, dyskinesia, abnormal thinking, tardive dyskinesia, vertigo, involuntary movements, confusion, amnesia, hyperkinesia, increased libido, incoordination, abnormal gait, myoclonus, apathy, ataxia, stupor, bruxism, hemiplegia, aphasia, buccoglossal syndrome, choreoathetosis, delirium, decreased libido, neuralgia, stuttering, akathisia, dystonia, parkinsonism, and subdural hematoma have also been reported; however, causality has not been established. Two cases of neuroleptic malignant syndrome that may possibly have been related to quetiapine use have also been reported. One case of quetiapine associated restless leg syndrome has been reported.

Nervous system side effects specifically associated with the extended-release tablets have included sedation (13%), somnolence (12%), and dizziness (10%).

Quetiapine has been associated with improvement on cognitive test performance in patients in the early stages of schizophrenia.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (9%), constipation (8%), vomiting (6%), dyspepsia (5%), gastroenteritis (2%), and increased gamma glutamyl transpeptidase level (1%). Anorexia, increased salivation, increased appetite, gingivitis, dysphagia, flatulence, gastroenteritis, gastritis, hemorrhoids, stomatitis, thirst, tooth caries, fecal incontinence, gastroesophageal reflux, gum hemorrhage, mouth ulceration, rectal hemorrhage tongue edema, glossitis, hematemesis, intestinal obstruction, melena, and pancreatitis have also been reported; however, causality has not been established.

Gastrointestinal side effects specifically associated with the extended-release tablets have included dry mouth (12%), constipation (6%), and dyspepsia (5%).

Cardiovascular

Cardiovascular side effects have included tachycardia (6%), postural hypotension (4%), and palpitation. Vasodilatation, QT interval prolongation, bradycardia, cerebral ischemia, irregular pulse, T wave abnormality, bundle branch block, cerebrovascular accident, venous thromboembolism, T wave inversion, anginal pectoris, atrial fibrillation, first degree atrioventricular (AV) block, congestive heart failure, elevated ST, thrombophlebitis, T wave flattening, ST abnormality, cardiomyopathy (including fatal cardiomyopathy), myocarditis, and increased QRS duration have also been reported.

Cardiovascular side effects specifically associated with the extended-release tablets have included orthostatic hypotension (7%).

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including quetiapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Similar results (i.e., increased risk of mortality with atypical antipsychotics) were reported in another meta-analysis involving elderly dementia patients that consisted of 15 randomized, placebo-controlled trials (n=3353) of 10 to 12 weeks in duration. Quetiapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

An increased risk of mortality, possibly due to heart failure or sudden death, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

The results of a large retrospective cohort study appear to indicate that atypical antipsychotic agents (i.e., risperidone, olanzapine, clozapine, quetiapine) increase the risk of venous thromboembolism in elderly patients; however, these events seem to be rare.

Endocrine

A study of U.S. military veterans with schizophrenia has reported that patients on quetiapine (the active ingredient contained in Seroquel) had 3.34 times as many cases of diabetes when compared to patients taking decades old drugs for psychosis including haloperidol, thioridazine, and others.

Additional studies have confirmed that patients receiving atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) are at an increased risk of developing hyperglycemia and/or diabetes mellitus.

Treatment with quetiapine has been shown to cause significant decreases in total serum thyroxine (T4) and triiodothyronine (T3) levels and a significant increase in thyroid-stimulating hormone (TSH) levels after 6 weeks of therapy.

Endocrine side effects have included hypothyroidism, diabetes mellitus, and hyperthyroidism. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) has also been associated with quetiapine use.

Metabolic

Treatment with quetiapine (the active ingredient contained in Seroquel) has been associated with moderate weight gain. Most of the weight gain (greater than 60%) appears to occur within the first 12 weeks of therapy with modest changes occurring after 6 months. In one study, the mean weight gain after 1 and 2 years of treatment with quetiapine was 3.19 kg (7 lbs) and 5.16 kg (11 lbs), respectively. The weight gain reported with quetiapine does not appear to be dose-related.

Metabolic side effects have included weight gain, increased SGPT, and increased SGOT in 5% of patients. Weight loss, hyperglycemia, and hypoglycemia have been reported infrequently. In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed.

Dermatologic

Dermatologic side effects have included rash (4%) and sweating. Pruritus, acne, eczema, contact dermatitis, maculopapular rash, seborrhea, skin ulcer, exfoliative dermatitis, psoriasis, and skin discoloration have also been reported; however, causality has not been established. A rare case of erythema multiforme minor, that resolved following discontinuation of quetiapine (the active ingredient contained in Seroquel) has been reported.

Respiratory

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including quetiapine (the active ingredient contained in Seroquel) for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Quetiapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

An increased risk of mortality, possibly due to an infection, such as pneumonia, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

A case of acute respiratory failure has been reported in a patient with COPD following a single oral dose of 50 mg.

Respiratory side effects have included pharyngitis (6%) and rhinitis (3%). Increased cough, dyspnea, pneumonia, epistaxis, asthma, hiccup, and hyperventilation have also been reported; however, causality has not been established. A single case of hyperventilation and respiratory alkalosis has been reported. One case of acute respiratory failure has been reported.

Other

Other side effects have included headache (21%), pain (7%), asthenia (5%), abdominal pain (4%), back pain (3%), fever (2%), and ear pain (1%). Flu syndrome, neck pain, pelvic pain, suicide attempt, malaise, photosensitivity reaction, chills, face edema, moniliasis, enlarged abdomen, migraine, peripheral edema, increased alkaline phosphatase level, hyperlipemia, alcohol intolerance, dehydration, increased creatinine, glycosuria, gout, hand edema, hypokalemia, tinnitus, deafness, and water intoxication have also been reported; however, causality has not been established. Postmarketing reports have included galactorrhea, agranulocytosis, hyponatremia, Stevens-Johnson syndrome, decreased platelets, somnambulism (and other related events) and hypothermia, however, causality has not been established.

Hematologic

Hematologic side effects have included leukopenia, leukocytosis, anemia, ecchymosis, eosinophilia, hypochromic anemia, lymphadenopathy, cyanosis, hemolysis, and thrombocytopenia; however, causality has not been established. A single case of thrombotic thrombocytopenic purpura has been reported. Decreases in hemoglobin to 13 g/dl or less in males and 12 g/dl or less in females have been reported.

Ocular

Ocular side effects have included amblyopia (2%). Conjunctivitis, abnormal vision, dry eyes, blepharitis, eye pain, abnormality of accommodation, and glaucoma have also been reported; however, causality has not been established. One case of cataracts has been reported. One case of photopsia has been reported.

One case of photopsia associated with high-dose quetiapine (1000 mg daily) has been reported. Symptoms resolved following a reduction in dose (900 mg daily).

Genitourinary

A 48 year old female with no prior history of urinary retention presented to the emergency room unable to void several months after initiating treatment with quetiapine (the active ingredient contained in Seroquel) The patient self prescribed an increase in dosage from 900 mg/day to 1800 mg/day several weeks prior to this incident. Ten days prior to the visit to the emergency department she increased dosage again to 2400 mg/day. The urinary retention resolved within 48 hours of decreasing dosage back to the prescribed 900 mg/day. Urinary hesitancy developed again two months later after the patient again increased her dosage to 1800 mg/day without medical advice. The condition again resolved following a return to a dosage of 900 mg/day.

Genitourinary side effects have included dysmenorrhea, vaginitis, urinary incontinence, metrorrhagia, impotence, dysuria, vaginal moniliasis, abnormal ejaculation, cystitis, urinary frequency, amenorrhea, female lactation, leukorrhea, vaginal hemorrhage, vulvovaginitis, orchitis, gynecomastia, nocturia, and polyuria; however, causality has not been established. Rare cases of priapism have been reported with quetiapine use.

Musculoskeletal

Two cases of rhabdomyolysis have been reported. One case occurred as a result of a quetiapine (the active ingredient contained in Seroquel) overdose and the second occurred after 14 days of quetiapine therapy (25 mg/day). In the second case, elevated serum creatinine kinase and liver enzyme levels gradually returned to normal following discontinuation of quetiapine.

Musculoskeletal side effects have included pathological fracture, myasthenia, twitching, arthralgia, arthritis, leg cramps, and bone pain; however, causality has not been established. Rare cases of rhabdomyolysis have been reported.

Psychiatric

Psychiatric side effects have included psychosis, hallucinations, paranoid reactions, delusions, manic reaction, depersonalization, catatonic reaction, emotional lability, suicide attempt, and euphoria.

Renal

Renal side effects have included acute kidney failure; however, causality has not been established.

Hepatic

A 30 year old patient experienced acute symptoms of cholestasis after 8 years of risperidone therapy. Once the drug was discontinued, the symptoms resolved completely. Eleven months later, quetiapine (the active ingredient contained in Seroquel) was introduced and the patient once again developed acute symptoms of cholestasis which later resolved after quetiapine discontinuation.

Hepatic side effects including at least one case of delayed onset cholestasis have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction have been reported.