Skip to Content

Seroquel XR Side Effects

Generic Name: quetiapine

Note: This document contains side effect information about quetiapine. Some of the dosage forms listed on this page may not apply to the brand name Seroquel XR.

In Summary

Common side effects of Seroquel XR include: dizziness, drowsiness, sedated state, and xerostomia. Other side effects include: dyspepsia, muscle rigidity, and orthostatic hypotension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to quetiapine: oral tablet, oral tablet extended release

Along with its needed effects, quetiapine (the active ingredient contained in Seroquel XR) 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
  • 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
  • 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


  • 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
  • painful or prolonged erection of the penis
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • tightness in the chest
  • tingling of the hands or feet
  • unusual weight gain or loss

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

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

For Healthcare Professionals

Applies to quetiapine: oral tablet, oral tablet extended release


The most common adverse reactions reported in adults have included somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, increased ALT, and dyspepsia. In children and adolescents, the most common adverse reactions reported have included somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and increased weight.


Very common (10% or more): Discontinuation syndrome (12.1%), agitation (up to 20%)

Common (1% to 10%): Anxiety, depression, irritability, hypersomnia, abnormal dreams, aggression, suicidal ideation and behavior

Uncommon (0.1% to 1%): Abnormal dreams, abnormal thinking, amnesia, psychosis, hallucinations, manic reaction, depersonalization, catatonic reaction

Rare (0.01% to 0.1%): Delirium, emotional lability, euphoria, somnambulism

Frequency not reported: Suicides, nightmares, drug withdrawal syndrome neonate, withdrawal symptoms[Ref]

Nervous system

Somnolence usually occurred during the first 2 weeks and resolved with continued therapy.[Ref]

Very common (10% or more): Somnolence (up to 57%), dizziness (up to 18%), headache (21%)

Common (1% to 10%): Hypertonia, incoordination, tremor, speech disorder, ataxia, lethargy, paresthesia, extrapyramidal disorder, balance disorder, hypoesthesia, restless leg syndrome, hypersomnia, tremor

Uncommon (0.1% to 1%): Seizures, akathisia, dyskinesia, tardive dyskinesia, involuntary movements, hyperkinesia, abnormal gait, myoclonus, bruxism, hemiplegia, taste perversion

Rare (less than 0.1%): Neuroleptic malignant syndrome, aphasia, buccoglossal syndrome, choreoathetosis, neuralgia, subdural hematoma

Postmarketing reports: Retrograde amnesia[Ref]


Very rare (less than 0.01%): Anaphylactic reactions

Frequency not reported: Hypersensitivity


Logistic regression analysis has shown a positive dose response for dyspepsia and abdominal pain.[Ref]

Very common (10% or more): Dry mouth (up to 44%),

Common (1% to 10%): Constipation, dyspepsia, vomiting, abdominal pain, gastroenteritis, gastroesophageal reflux disease, dysphagia

Uncommon (0.1% to 1%): Increased salivation, gingivitis, flatulence, hemorrhoids, stomatitis, mouth ulceration, tongue edema

Rare (0.01% to 0.1%): Glossitis, hematemesis, intestinal obstruction, melena

Frequency not reported: Pancreatitis[Ref]


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 XR) 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.

Blood pressure elevations described as systolic elevations of 20 mmHg or greater and diastolic elevations of 10 mmHg or greater were observed in 15.2% and 40.6% of children and adolescents, respectively. One child with a history of hypertension experienced a hypertensive crisis.

QT intervals have not been systematically evaluated. During clinical trials, persistent increases in QT intervals were not identified; however there have been postmarketing reports of QT prolongation in patients who overdosed on this drug, in patients with concomitant illness, and in patients taking drugs that are known to cause electrolyte imbalance or QT interval prolongation.[Ref]

Very common (10% or more): Systolic (15.2%) and diastolic (40.6%) blood pressure elevations in pediatric patients

Common (1% to 10%): Syncope, tachycardia, postural hypotension, peripheral edema, hypotension, hypertension, palpitations

Uncommon (0.1% to 1%): Bundle branch block

Rare (0.01% to 0.1%): Angina pectoris, atrial fibrillation, AV bloc first degree, congestive heart failure, ST elevated, T wave flattening, ST abnormality, increased QRS duration, venous thromboembolism

Very rare (less than 0.01%): Hypertensive crisis

Frequency not reported: Cardiomyopathy, myocarditis, bradycardia, peripheral edema

Postmarketing reports: QT prolongation[Ref]


Common (1% to 10%): Shifts in thyroid hormones and TSH, hyperprolactinemia, altered hormone levels, hypothyroidism

Uncommon (0.1% to 1%): Hypothyroidism

Rare (0.01% to 0.1%): Gynecomastia, hyperthyroidism

Frequency not reported: Priapism

Postmarketing reports: Syndrome of inappropriate hormone secretion (SIADH)[Ref]

In adults, dose-related decreases in thyroid hormone levels have been observed. It appears that maximal reductions in total and free thyroxine (T4) occur in the first 6 weeks of treatment and are maintained without adaptation or progression during chronic therapy. Upon therapy discontinuation, these effects mostly return to baseline values. The mechanism by which this drug affects the thyroid axis is unclear.[Ref]


Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. While these effects have been shown as a class effect, each agent has its own profile.

Hyperglycemia: Adults: In controlled clinical trials of 12 weeks or less, 2.4% of patients with normal (less than 100 mg/dL) fasting plasma glucose (FPG) had at least 1 FPG reading of 126 mg/dL or greater (vs. placebo 1.4%) during treatment. For patients with baseline borderline to high FPG (100 mg/dL or higher), 11.7% had at least 1 FPG reading of 126 mg/dL or greater (vs. placebo, 11.8%). In 2 longer-term trials, the mean change in blood glucose from baseline in patients treated with quetiapine (the active ingredient contained in Seroquel XR) (mean exposure 213 days; n=646) was 5 mg/dL (vs. placebo -0.05 mg/dL). Among patients with major depressive disorder receiving the extended-release formulation of this drug, a FBG greater than 126 mg/dL occurred in 7%, 12%, and 6% of those receiving 150 mg, 300 mg, or placebo.

Pediatrics: In a study of patients 10 to 17 years old with bipolar mania, the mean change in fasting glucose was 3.62 mg/dL (n=170). No patients with a baseline fasting glucose level lower than 126 mg/dL had a treatment-emergent blood glucose level greater than 126 mg/dL.

Dyslipidemia: Across indications, adult patients who experienced shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically significant levels occurred in up to 18%, 22%, 6%, and 14% of patients receiving this drug compared with up to 7%, 16%, 5%, and 14% receiving placebo, respectively. For pediatric patients, the shifts were up to 12%, 22%, 8%, and 15% compared to up to 3%, 13%, 5%, and 19% for this drug and placebo, respectively.

Weight gain: Logistic regression analysis has shown a positive dose response for weight gain. Five to 10% of adult patients experienced a weight gain of 7% or greater (vs. up to 5% in placebo). Among children and adolescents, a weight gain of 7% or greater occurred in 7% to 21% of patients receiving this drug compared with up to 7% in placebo patients. Mean change in body weight was 1.7 to 2 kg in 3 to 6 week trials and 4.4 kg in 26 week trials. These results were not adjusted for normal growth.[Ref]

Very common (10% or more): Hyperglycemia, increases in serum triglycerides, hyperlipidemia,

Common (1% to 10%): Weight gain, increased appetite, thirst

Uncommon (0.1% to 1%): Weight loss, alkaline phosphatase increased, hyperglycemia, hypoglycemia

Rare (0.01% to 0.1%): Glycosuria, gout, hypokalemia, water intoxication, metabolic syndrome

Postmarketing reports: Hyponatremia[Ref]


Common (1% to 10%): Rash, sweating, acne

Uncommon (0.1% to 1%): Photosensitivity reaction, pruritus, eczema, contact dermatitis, maculopapular rash, seborrhea, skin ulcer, ecchymosis

Rare (0.01% to 0.1%): Exfoliative dermatitis, psoriasis, skin discoloration

Frequency not reported: Erythema multiforme

Postmarketing reports: Steven-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)[Ref]


Common (1% to 10%): Pharyngitis, rhinitis, sinusitis, nasal congestion, cough, sinus congestion, epistaxis, upper respiratory tract infection

Uncommon (0.1% to 1%): Pneumonia, asthma

Rare (0.01% to 0.1%): Hiccup, hyperventilation

Frequency not reported: Dyspnea[Ref]


Common (1% to 10%): Pain, asthenia, fever, balance disorder,

Frequency not reported: Hypothermia, vertigo[Ref]


Very common (10% or more): Decreased hemoglobin

Common (1% to 10%): Decreased neutrophil count, leucopenia

Uncommon (0.1% to 1%): Leukocytosis, anemia, eosinophilia, lymphadenopathy, decreased platelets

Rare (0.01% to 0.1%): Agranulocytosis

Frequency not reported: Leukopenia/neutropenia, eosinophilia[Ref]


Common (1% to 10%): Amblyopia, blurred vision

Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision, dry eyes, blepharitis, eye pain

Rare (0.01% to 0.1%): Glaucoma

Frequency not reported: Lens changes[Ref]


Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Urinary retention, moniliasis, dysmenorrhea, vaginitis, urinary incontinence, metrorrhagia, dysuria, abnormal ejaculation,

Rare (0.01% to 0.1%): Nocturia, polyuria

Frequency not reported: Galactorrhea

Postmarketing reports: Nocturnal enuresis[Ref]


Common (1% to 10%): Back pain, twitching, arthralgia, dysarthria, extremity pain, muscle rigidity, musculoskeletal stiffness

Uncommon (0.1% to 1%): Pathological fracture, myasthenia, leg cramps, bone pain

Frequency not reported: Elevations in serum creatine phosphokinase (not associated with NMS)

Postmarketing reports: Rhabdomyolysis[Ref]


Rare (0.01% to 0.1%): Acute renal failure[Ref]


Common (1% to 10%): Increased ALT, increased AST

Rare (0.01% to 0.1%): Jaundice, hepatitis

Frequency not reported: Gamma GT elevations[Ref]


Common (1% to 10%): Infection, tooth abscess

Frequency not reported: Influenza


1. "Product Information. Seroquel (quetiapine)." Zeneca Pharmaceuticals, Wilmington, DE.

2. Keating GM, Robinson DM "Quetiapine : a review of its use in the treatment of bipolar depression." Drugs 67 (2007): 1077-95

3. Bharadwaj R, Grover S "Parkinsonism and akathisia with quetiapine: three case reports." J Clin Psychiatry 69 (2008): 1189-91

4. "Product Information. Seroquel XR (quetiapine)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

5. Davidson M, Galderisi S, Weiser M, et al. "Cognitive Effects of Antipsychotic Drugs in First-Episode Schizophrenia and Schizophreniform Disorder: A Randomized, Open-Label Clinical Trial (EUFEST)." Am J Psychiatry (2009):

6. Jonnalagada JR, Norton JW "Acute dystonia with quetiapine." Clin Neuropharmacol 23 (2000): 229-30

7. Pinninti NR, Mago R, Townsend J, Doghramji K "Periodic Restless Legs Syndrome Associated With Quetiapine Use: A Case Report." J Clin Psychopharmacol 25 (2005): 617-618

8. Ghelber D, Belmaker RH "Tardive dyskinesia with quetiapine." Am J Psychiat 156 (1999): 796-7

9. Ghaemi SN, Ko JY "Quetiapine-related tardive dyskinesia." Am J Psychiatry 158 (2001): 1737

10. FDA. U.S. Food and Drug Admiinistration. Center for Drug Evaluation and Research "FDA Public Health Advisory. Deaths and antipsychotics in elderly patients with behavioral disturbances. Available from: URL:" ([2005 Apr 11]):

11. Schneider LS, Dagerman KS, Insel P "Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials." JAMA 294 (2005): 1934-43

12. Liperoti R, Pedone C, Lapane KL, Mor V, Bernabei R, Gambassi G "Venous thromboembolism among elderly patients treated with atypical and conventional antipsychotic agents." Arch Intern Med 165 (2005): 2677-82

13. Bush A, Burgess C "Fatal cardiomyopathy due to quetiapine." N Z Med J 121 (2008): U2909

14. Gianfrancesco F, Pesa J, Wang RH, Nasrallah H "Assessment of antipsychotic-related risk of diabetes mellitus in a Medicaid psychosis population: Sensitivity to study design." Am J Health Syst Pharm 63 (2006): 431-41

15. Atalay A, Turhan N, Aki OE "A challenging case of syndrome of inappropriate secretion of antidiuretic hormone in an elderly patient secondary to quetiapine." South Med J 100 (2007): 832-3

16. Liappas J, Paparrigopoulos T, Mourikis I, Soldatos C "Hypothyroidism induced by quetiapine: a case report." J Clin Psychopharmacol 26 (2006): 208-9

17. Greenspan A, Gharabawi G, Kwentus J "Thyroid dysfunction during treatment with atypical antipsychotics." J Clin Psychiatry 66 (2005): 1334-5

18. Marlowe KF, Howard D, Chung A "New onset diabetes with ketoacidosis attributed to quetiapine." South Med J 100 (2007): 829-31

19. Guo JJ, Keck PE, Corey-Lisle PK, et al. "Risk of diabetes mellitus associated with atypical antipsychotic use among medicaid patients with bipolar disorder: a nested case-control study." Pharmacotherapy 27 (2007): 27-35

20. Melkersson K, Dahl ML "Adverse metabolic effects associated with atypical antipsychotics : literature review and clinical implications." Drugs 64 (2004): 701-23

21. Sernyak MJ, Gulanski B, Rosenheck R "Undiagnosed hyperglycemia in patients treated with atypical antipsychotics." J Clin Psychiatry 66 (2005): 1463-7

22. Burton, TM "New antipsychotic-drug class is tied to increase in diabetes. Available from: URL:,,SB106150445385585800,00.html." ([2003 Aug]):

23. Sobel M, Jaggers ED, Franz MA "New-onset diabetes mellitus associated with the initiation of quetiapine treatment." J Clin Psychiatry 60 (1999): 556-7

24. Brecher M, Leong RW, Stening G, Osterling-Koskinen L, Jones AM "Quetiapine and long-term weight change: a comprehensive data review of patients with schizophrenia." J Clin Psychiatry 68 (2007): 597-603

25. Lin GL, Chiu CH, Lin SK "Quetiapine-induced Erythema Multiforme Minor: A Case Report." J Clin Psychopharmacol 26 (2006): 668-669

26. Shelton PS, Barnett FL, Krick SE "Hyperventilation associated with quetiapine." Ann Pharmacother 34 (2000): 335-7

27. Jabeen S, Polli SI, Gerber DR "Acute respiratory failure with a single dose of quetiapine fumarate." Ann Pharmacother 40 (2006): 359-62

28. Clark N, Weissberg E, Noel J "Quetiapine and leukopenia." Am J Psychiat 158 (2001): 817-8

29. Valibhai F, Phan NB, Still DJ, True J "Cataracts and quetiapine." Am J Psychiat 158 (2001): 966

30. Hazra M, Culo S, Mamo D "High-dose Quetiapine and Photopsia." J Clin Psychopharmacol 26 (2006): 546-7

31. Montejo Gonzalez AL, Rico-Villademoros F, Tafalla M, Majadas S "A 6-Month Prospective Observational Study on the Effects of Quetiapine on Sexual Functioning." J Clin Psychopharmacol 25 (2005): 533-538

32. Davol P, Rukstalis D "Priapism associated with routine use of quetiapine: case report and review of the literature." Urology 66 (2005): 880

33. Sokolski KN, Brown BJ, Melden M "Urinary retention following repeated high-dose quetiapine." Ann Pharmacother 38 (2004): 899-900

34. Himmerich H, Ehrlinger M, Hackenberg M, Lohr B, Nickel T "Possible Case of Quetiapine-induced Rhabdomyolysis in a Patient With Depression Treated With Fluoxetine." J Clin Psychopharmacol 26 (2006): 676-677

35. Wright TM, Vandenberg AM "Risperidone- and quetiapine-induced cholestasis." Ann Pharmacother 41 (2007): 1518-23

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.