Summary

Commonly reported side effects of quetiapine include: asthenia, constipation, dizziness, drowsiness, headache, sedated state, increased serum cholesterol, increased serum triglycerides, increased thyroid stimulating hormone level, and xerostomia. Other side effects include: abdominal pain, dyspepsia, increased serum alanine aminotransferase, orthostatic hypotension, pharyngitis, weight gain, muscle rigidity, and tachycardia. Continue reading for a comprehensive list of adverse effects.

Applies to quetiapine: oral tablets.

Side effects include:

Somnolence, dizziness, dry mouth, constipation, increased ALT, weight gain, dyspepsia.

For Healthcare Professionals

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

General

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

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]

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]

Gastrointestinal

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

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]

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

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]

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]

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]