Seroquel XR Side Effects

Generic name: quetiapine

Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.

Note: This document provides detailed information about Seroquel XR Side Effects associated with quetiapine. Some dosage forms listed on this page may not apply specifically to the brand name Seroquel XR.

Applies to quetiapine: oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release)

Increased Mortality in Elderly Patients with Dementia-Related Psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Quetiapine fumarate is not approved for the treatment of patients with dementia-related psychosis.Suicidal Thoughts and Behaviors. Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants.Monitor for worsening and emergence of suicidal thoughts and behaviors.

Serious side effects of Seroquel XR

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 side effects

• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sleepiness or unusual drowsiness

Less common side effects

• black, tarry stools
• blurred vision
• changes in patterns and rhythms of speech
• chest pain
• cough
• drooling
• fever
• 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
• muscle aches
• 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
• sore throat
• 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 side effects

• dry, puffy skin
• fast, pounding, or irregular heartbeat
• loss of appetite
• menstrual changes
• 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
• agitation
• bed-wetting
• blistering, peeling, or loosening of the skin
• bloating
• bluish lips or skin
• chest discomfort
• constipation
• dark urine
• decreased awareness or responsiveness
• decreased urine output
• depression
• diarrhea
• difficulty breathing
• difficulty in passing urine (dribbling)
• difficulty swallowing
• dizziness
• faintness
• general feeling of tiredness or weakness
• headache
• hives, itching, skin rash
• hoarseness
• increased thirst
• indigestion
• irritability
• joint or muscle pain
• light-colored stools
• loss of consciousness
• lower back or side pain
• muscle cramps, spasms, stiffness, or twitching
• nausea
• painful or prolonged erection of the penis
• painful urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• severe constipation
• severe sleepiness
• severe vomiting
• sore throat
• stomach pain, continuing
• tightness in the chest
• tingling of the hands or feet
• unusual bleeding or bruising unusual drowsiness, dullness, or feeling of sluggishness
• unusual weight gain or loss
• upper right abdominal pain
• vomiting
• yellow eyes or skin

Other side effects of Seroquel XR

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:

Less common side effects

• abnormal vision
• belching
• decreased appetite
• decreased strength and energy
• heartburn
• increased appetite
• increased muscle tone
• increased sweating
• indigestion
• sneezing
• stomach discomfort or upset
• stuffy or runny nose

For healthcare professionals

Applies to quetiapine: oral tablet, oral tablet extended release.

General adverse events

IR Formulations: The most commonly reported side effects included somnolence, dry mouth, weight gain, elevated triglycerides, headache, and agitation.

XR/XL Tablets: The most commonly reported side effects included somnolence, dry mouth, and sedation.^[Ref]

Nervous system

IR Formulations:

• Very common (10% or more): Somnolence (up to 57%), headache (up to 21%), dizziness (up to 19%), sedation (up to 18.3%), extrapyramidal symptoms (up to 12.9%)
• Common (1% to 10%): Akathisia, ataxia, balance disorder, dysarthria, dyskinesia, dyskinetic event, dystonic event, extrapyramidal disorder, hypersomnia, hypertonia, hypoesthesia, incoordination, lethargy, other extrapyramidal event, paresthesia, parkinsonism, restless legs syndrome, seizure, speech disorder, syncope, tardive dyskinesia, tremor
• Uncommon (0.1% to 1%): Amnesia, cerebrovascular accident, hemiplegia, hyperkinesia, involuntary movements, migraine, myoclonus, stupor, taste perversion, vertigo
• Rare (0.01% to 0.1%): Aphasia, cerebral ischemia, choreoathetosis, neuralgia, neuroleptic malignant syndrome (NMS), subdural hematoma
• Frequency not reported: Stroke
• Postmarketing reports: Cerebrovascular accident, retrograde amnesia

XR/XL Tablets:

• Very common (10% or more): Somnolence (up to 53%), sedation (up to 31.9%), dizziness (up to 18%), headache (up to 17.5%), extrapyramidal symptoms (up to 11.2%)
• Common (1% to 10%): Akathisia, disturbance in attention, dysarthria, dyskinetic event, dystonic event, hypersomnia, lethargy, mental impairment, migraine, other extrapyramidal event, paresthesia, parkinsonism, restless legs syndrome, sinus headache, syncope, tremor, vertigo
• Uncommon (0.1% to 1%): Seizure, tardive dyskinesia
• Rare (0.01% to 0.1%): NMS
• Frequency not reported: Akinesia, cerebrovascular adverse reactions, choreoathetosis, cognitive impairment, cogwheel rigidity, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, motor impairment, movement disorder, parkinsonian gait, psychomotor agitation, psychomotor hyperactivity, stroke
• Postmarketing reports: Cerebrovascular accident, retrograde amnesia^[Ref]

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

Metabolic

IR Formulations:

• Very common (10% or more): Weight gain (up to 45%), elevated triglycerides (up to 23%), decreased fasting high-density lipoprotein (HDL) cholesterol (up to 18.3%), total cholesterol elevations (up to 16%), increased appetite (up to 10%)
• Common (1% to 10%): Anorexia, blood glucose increased to hyperglycemic levels, thirst
• Uncommon (0.1% to 1%): Alcohol intolerance, alkaline phosphatase increased, dehydration, diabetes mellitus, exacerbation of pre-existing diabetes, hyperglycemia, hyperlipidemia, hypoglycemia, hyponatremia, weight loss
• Rare (0.01% to 0.1%): Gout, hypokalemia, metabolic syndrome, water intoxication

XR/XL Tablets:

• Very common (10% or more): Triglyceride elevations (up to 18%), total cholesterol elevations (up to 17%), increased appetite (up to 12%)
• Common (1% to 10%): Blood glucose increased to hyperglycemic levels, decreased appetite, increased blood glucose, weight gain/weight increased
• Uncommon (0.1% to 1%): Diabetes mellitus, exacerbation of pre-existing diabetes, hyponatremia
• Rare (0.01% to 0.1%): Metabolic syndrome^[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 this drug (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. 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]

Gastrointestinal

IR Formulations:

• Very common (10% or more): Dry mouth (up to 44%), vomiting (up to 10.8%), constipation (up to 10%), nausea (up to 10%)
• Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, dysphagia, gastroenteritis, gastroesophageal reflux disease (GERD), stomach discomfort, stomatitis, tooth abscess
• Uncommon (0.1% to 1%): Fecal incontinence, flatulence, gastritis, gingivitis, gum hemorrhage, hemorrhoids, increased salivation, rectal hemorrhage, tongue edema, tooth caries, mouth ulceration
• Rare (0.01% to 0.1%): Abdomen enlarged, buccoglossal syndrome, glossitis, hematemesis, intestinal ileus, intestinal obstruction, melena, pancreatitis

XR/XL Tablets:

• Very common (10% or more): Dry mouth (up to 40%), nausea (up to 13.3%), constipation (up to 11%)
• Common (1% to 10%): Diarrhea, dyspepsia, toothache, viral gastroenteritis, vomiting
• Uncommon (0.1% to 1%): Dysphagia
• Rare (0.01% to 0.1%): Intestinal ileus, intestinal obstruction, pancreatitis^[Ref]

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

Other

IR Formulations:

• Very common (10% or more): Asthenia (up to 17.6%), fatigue (up to 14%)
• Common (1% to 10%): Accidental overdose, ear pain, fever, heaviness, mild asthenia, pain, pyrexia
• Uncommon (0.1% to 1%): Abnormal gait, chills, malaise, tinnitus
• Rare (0.01% to 0.1%): Hypothermia, deafness
• Frequency not reported: Falls, increased mortality

XR/XL Tablets:

• Very common (10% or more): Fatigue (up to 14%)
• Common (1% to 10%): Ear pain, fall, mild asthenia, pyrexia, sluggishness
• Rare (0.01% to 0.1%): Hypothermia
• Frequency not reported: Increased mortality^[Ref]

Psychiatric

IR Formulations:

• Very common (10% or more): Agitation (up to 20%), discontinuation symptoms (up to 16%)
• Common (1% to 10%): Abnormal dreams, aggression, anxiety, depression, insomnia, irritability, nightmares, suicidal behavior, suicidal ideation, suicide-related events, thinking abnormal
• Uncommon (0.1% to 1%): Apathy, bruxism, catatonic reaction, confusion, delusions, depersonalization, hallucinations, libido increased, manic reaction, paranoid reaction, psychosis, suicide attempt
• Rare (0.01% to 0.1%): Delirium, emotional lability, euphoria, libido decreased, neonatal withdrawal, sleep-related eating disorder, sleep talking, somnambulism and other related events, stuttering
• Frequency not reported: Drug withdrawal syndrome neonatal
• Postmarketing reports: Nocturnal enuresis

XR/XL Tablets:

• Common (1% to 10%): Abnormal dreams, anxiety, confusional state, depression, discontinuation/withdrawal symptoms, disorientation, insomnia, irritability, libido decreased, nightmares, restlessness, schizophrenia, suicidal behavior, suicidal ideation, suicide-related events
• Rare (0.01% to 0.1%): Sleep-related eating disorder, sleep talking, somnambulism and related reactions
• Frequency not reported: Drug withdrawal syndrome neonatal
• Postmarketing reports: Nocturnal enuresis^[Ref]

Cardiovascular

Immediate-Release (IR) Formulations:

• Very common (10% or more): Postural hypotension (up to 12.2%), tachycardia (up to 11%)
• Common (1% to 10%): Hypotension, hypertension, increased blood pressure, orthostatic hypotension, pallor, palpitations, peripheral edema, sinus tachycardia
• Uncommon (0.1% to 1%): Bradycardia, bundle branch block, cyanosis, deep thrombophlebitis, irregular pulse, QT interval prolonged, T wave abnormality, T wave inversion, vasodilation
• Rare (0.01% to 0.1%): Angina pectoris, atrial fibrillation, atrioventricular (AV) block first degree, congestive heart failure, hand edema, increased QRS duration, ST abnormality, ST elevated, thrombophlebitis, T wave flattening, venous thromboembolism
• Postmarketing reports: Cardiomyopathy, myocarditis

Extended-Release (XR)/Prolonged-release (XL) Tablets:

• Common (1% to 10%): Heart rate increased, hypotension, increases in blood pressure, orthostatic hypotension, palpitations, peripheral edema, tachycardia
• Uncommon (0.1% to 1%): Bradycardia, QT prolongation
• Rare (0.01% to 0.1%): Venous thromboembolism
• Postmarketing reports: Cardiomyopathy, myocarditis^[Ref]

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including this drug, 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. This drug should not be used to treat 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 (e.g., clozapine, olanzapine, risperidone, this drug) 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. A 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]

Hematologic

IR Formulations:

• Very common (10% or more): Decreased hemoglobin (Up to 11%)
• Common (1% to 10%): Decreased neutrophil count, eosinophils increased, leukopenia, neutropenia
• Uncommon (0.1% to 1%): Anemia, eosinophilia, hypochromic anemia, leukocytosis, lymphadenopathy, platelet count decreased, severe neutropenia, thrombocytopenia
• Rare (0.01% to 0.1%): Agranulocytosis, hemolysis

XR/XL Tablets:

• Very common (10% or more): Decreased hemoglobin (up to 11%)
• Common (1% to 10%): Decreased neutrophil count, eosinophils increased, leukopenia
• Uncommon (0.1% to 1%): Anemia, neutropenia, platelet count decreased, thrombocytopenia
• Rare (0.01% to 0.1%): Agranulocytosis^[Ref]

Respiratory

IR Formulations:

• Common (1% to 10%): Cough, cough increased, dyspnea, epistaxis, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, sinus congestion, sinusitis, upper respiratory tract infection
• Uncommon (0.1% to 1%): Asthma, pneumonia
• Rare (0.01% to 0.1%): Hiccup, hyperventilation

XR/XL Tablets:

• Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis, sinus congestion, sinusitis, upper respiratory tract infection
• Uncommon (0.1% to 1%): Rhinitis^[Ref]

Endocrine

IR Formulations:

• Common (1% to 10%): Decreased total T3, decreased free T4, decreased total T4, hormone levels altered, hyperprolactinemia, hypothyroidism, increased thyroid stimulating hormone (TSH), serum prolactin elevations
• Uncommon (0.1% to 1%): Decreased free T3
• Rare (0.01% to 0.1%): Gynecomastia, hyperthyroidism
• Postmarketing reports: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

XR/XL Tablets:

• Common (1% to 10%): Decreased free T4, decreased total T3, decreased total T4, elevations in serum prolactin, hyperprolactinemia, increased TSH
• Uncommon (0.1% to 1%): Decreased free T3, hypothyroidism
• Very rare (less than 0.01%): 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]

Musculoskeletal

IR Formulations:

• Common (1% to 10%): Arthralgia, back pain, muscle rigidity, musculoskeletal stiffness, pain in extremity, twitching
• Uncommon (0.1% to 1%): Arthritis, bone pain, leg cramps, neck pain, myasthenia, pathological fracture
• Rare (0.01% to 0.1%): Elevations in blood creatine phosphokinase
• Very rare (less than 0.01%): Rhabdomyolysis

XR/XL Tablets:

• Common (1% to 10%): Arthralgia, back pain, muscle spasms, myalgia, neck pain
• Rare (0.01% to 0.1%): Elevations in blood creatine phosphokinase
• Very rare (less than 0.01%): Rhabdomyolysis
• Frequency not reported: Muscle rigidity, neck rigidity, nuchal rigidity^[Ref]

Hepatic

IR Formulations:

• Common (1% to 10%): ALT increased, AST increased, GGT increased
• Rare (0.01% to 0.1%): Hepatitis, jaundice
• Postmarketing reports: Cholestatic liver injury, hepatic failure/fatal hepatic failure, hepatic steatosis, mixed liver injury

XR/XL Tablets:

• Common (1% to 10%): Elevations in ALT, elevations in GGT, transaminase elevations
• Uncommon (0.1% to 1%): Elevations in AST
• Rare (0.01% to 0.1%): Hepatitis, jaundice
• Postmarketing reports: Cholestatic liver injury, hepatic failure/fatal hepatic failure, hepatic steatosis, mixed liver injury^[Ref]

Dermatologic

IR Formulations:

• Common (1% to 10%): Acne, rash, sweating
• Uncommon (0.1% to 1%): Allergic skin reactions, contact dermatitis, ecchymosis, eczema, face edema, maculopapular rash, photosensitivity reaction, pruritus, seborrhea, skin ulcer
• Rare (0.01% to 0.1%): Exfoliative dermatitis, psoriasis, skin discoloration
• Very rare (less than 0.01%): Stevens-Johnson syndrome (SJS)
• Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, toxic epidermal necrolysis (TEN)

XR/XL Tablets:

• Common (1% to 10%): Hyperhidrosis
• Uncommon (0.1% to 1%): Allergic skin reactions
• Very rare (less than 0.01%): SJS
• Frequency not reported: DRESS, erythema multiforme, TEN^[Ref]

Immunologic

IR Formulations:

• Common (1% to 10%): Flu syndrome, infection
• Uncommon (0.1% to 1%): Moniliasis

XR/XL Tablets:

• Common (1% to 10%): Influenza, seasonal allergy^[Ref]

Ocular

IR Formulations:

• Common (1% to 10%): Amblyopia, vision blurred
• Uncommon (0.1% to 1%): Abnormal vision, blepharitis, conjunctivitis, dry eyes, eye pain
• Rare (0.01% to 0.1%): Abnormality of accommodation, glaucoma
• Postmarketing reports: Cataract

XR/XL Tablets:

• Common (1% to 10%): Vision blurred
• Frequency not reported: Oculogyration
• Postmarketing reports: Cataract^[Ref]

Genitourinary

IR Formulations:

• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Abnormal ejaculation, amenorrhea, cystitis, dysmenorrhea, dysuria, female lactation, impotence, leukorrhea, metrorrhagia, orchitis, pelvic pain, sexual dysfunction, urinary frequency, urinary incontinence, urinary retention, vaginal hemorrhage, vaginal moniliasis, vaginitis, vulvovaginitis
• Rare (0.01% to 0.1%): Breast swelling, galactorrhea, menstrual disorder, nocturia, polyuria, priapism

XR/XL Tablets:

• Common (1% to 10%): Pollakiuria
• Uncommon (0.1% to 1%): Sexual dysfunction, urinary retention
• Rare (0.01% to 0.1%): Breast swelling, galactorrhea, menstrual disorder, priapism^[Ref]

Hypersensitivity

IR Formulations:

• Uncommon (0.1% to 1%): Hypersensitivity
• Very rare (less than 0.01%): Anaphylactic reaction, angioedema

XR/XL Tablets:

• Uncommon (0.1% to 1%): Hypersensitivity
• Very rare (less than 0.01%): Anaphylactic reaction, angioedema^[Ref]

Renal

IR Formulations:

• Uncommon (0.1% to 1%): Creatinine increased
• Rare (0.01% to 0.1%): Acute kidney failure, glycosuria^[Ref]

Frequently asked questions

• Does Seroquel (quetiapine) help you sleep?
• What drugs cause tardive dyskinesia?

Further information

Seroquel XR side effects can vary depending on the individual. 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.

Medical Disclaimer