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Quetiapine Side Effects

In Summary

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

For the Consumer

Applies to quetiapine: oral tablet, oral tablet extended release

As well as its needed effects, quetiapine may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking quetiapine, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking quetiapine, get emergency help immediately:

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

Minor Side Effects

Some quetiapine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

For Healthcare Professionals

Applies to quetiapine: oral tablet, oral tablet extended release

General

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.

Psychiatric

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]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions
Frequency not reported: Hypersensitivity

Gastrointestinal

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]

Cardiovascular

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.

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]

Endocrine

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]

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 quetiapine (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]

Dermatologic

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]

Respiratory

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]

Other

Common (1% to 10%): Pain, asthenia, fever, balance disorder,
Frequency not reported: Hypothermia, vertigo[Ref]

Hematologic

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]

Ocular

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]

Genitourinary

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]

Musculoskeletal

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]

Renal

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

Hepatic

Common (1% to 10%): Increased ALT, increased AST
Rare (0.01% to 0.1%): Jaundice, hepatitis
Frequency not reported: Gamma GT elevations[Ref]

Immunologic

Common (1% to 10%): Infection, tooth abscess
Frequency not reported: Influenza

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It is possible that some side effects of quetiapine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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