Frequently reported side effects of quetiapine include: constipation, dizziness, sleepiness, headache, sedation, weakness, increased serum cholesterol, increased serum triglycerides, increased thyroid stimulating hormone level, and xerostomia. Opposite effects include: abdominal pain, dyspepsia, increased serum alanine aminotransferase, orthostatic hypotension, pharyngitis, weight gain, muscle rigidity, and tachycardia. See listed below for an extensive list of negative results.
For the Consumer
Uses to quetiapine: oral tablet, oral tablet extended release
In addition to its necessary impacts, quetiapine might cause unwanted side effects that need medical attention.
Major Side Effects of Quetiapine
If any of the following side effects occur while taking quetiapine, consult your doctor right away:
More common:
- chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness or uncommon drowsiness
Less typical:
- black, tarry stools
- blurred vision
- changes in patterns and rhythms of speech
- chest pain
- cough
- drooling
- fever, muscle pains, or sore throat
- inability to move the eyes
- failure to sit still
- increased blinking or convulsions of the eyelid
- lip smacking or puckering
- vertigo control
- mask-like face
- need to keep moving
- painful or hard urination
- puffing of the cheeks
- fast or worm-like movements of the tongue
- uneasyness
- 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
- standing out of the tongue
- tightness 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
- unchecked chewing movements
- uncontrolled motions of the arms and legs
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- uncommon bleeding or bruising
- uncommon facial expressions
- unusual exhaustion or weakness.
See also: Quetiapine for Sleep
Uncommon
- dry, puffy skin
- fast, pounding, or irregular heartbeat
- loss of appetite
- menstrual changes
- exhaustion
- uncommon secretion of milk (in females)
- weight gain.
Occurrence unknowned:
- 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.
Minor Side Effects of Quetiapine
Some quetiapine side effects may not need any medical attention. As your body gets used to the medicine these side effects may vanish. Your healthcare expert might have the ability to help you prevent or reduce these side effects, but do contact them if any of the following side effects continue, or if you are concerned about them:
More typical:
Less common:
- abnormal vision
- acid or sour stomach
- belching
- reduced hunger
- decreased strength and energy
- headache
- heartburn
- increased hunger
- increased muscle tone
- increased sweating
- increased weight
- indigestion
- sneezing
- stomach discomfort, upset, or pain
- stuffy or runny nose.
For Healthcare Professionals
Uses to quetiapine: oral tablet, oral tablet extended release
General
The most typical negative reactions reported in adults have included somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, sleepiness, increased ALT, and dyspepsia. In children and teenagers, the most typical unfavorable reactions reported have included somnolence, dizziness, tiredness, increased cravings, queasiness, vomiting, dry mouth, tachycardia, and increased weight.
Psychiatric
Typical (10% or more): Discontinuation syndrome (12.1%), agitation (as much as 20%).
Typical (1% to 10%): Anxiety, depression, irritation, hypersomnia, unusual dreams, aggression, self-destructive ideation and habits.
Uncommon (0.1% to 1%): Abnormal dreams, unusual thinking, amnesia, psychosis, hallucinations, manic response, depersonalization, catatonic reaction.
Uncommon (0.01% to 0.1%): Delirium, emotional lability, ecstasy, somnambulism.
Frequency not reported: Suicides, nightmares, drug withdrawal syndrome neonate, withdrawal symptoms
Nervous system
Somnolence generally happened during the first 2 weeks and solved with ongoing therapy.
Typical (10% or more): Somnolence (up to 57%), dizziness (approximately 18%), headache (21%).
Typical (1% to 10%): Hypertonia, incoordination, tremor, speech disorder, ataxia, lethargy, paresthesia, extrapyramidal disorder, balance condition, hypoesthesia, restless leg syndrome, hypersomnia, trembling.
Uncommon (0.1% to 1%): Seizures, akathisia, dyskinesia, tardive dyskinesia, uncontrolled motions, 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.
Hypersensitivity.
Very rare (less than 0.01%): Anaphylactic responses.
Frequency not reported: Hypersensitivity.
Gastrointestinal
Logistic regression analysis has actually shown a favorable dosage action for dyspepsia and abdominal pain.
Typical (10% or more): Dry mouth (approximately 44%),
Typical (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 ulcer, tongue edema.
Unusual (0.01% to 0.1%): Glossitis, hematemesis, intestinal tract obstruction, melena.
Frequency not reported: Pancreatitis.
Cardiovascular
Collective data gathered from 17 placebo-controlled clinical studies (n= 5106) including making use of atypical antipsychotic agents, consisting of quetiapine, for the treatment of behavioral disorders in the elderly patient with dementia revealed 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, abrupt death) or contagious (e.g., pneumonia) in nature. Similar results (i.e., increased risk of mortality with atypical antipsychotics) were reported in another meta-analysis including senior dementia patients that consisted of 15 randomized, placebo-controlled trials (n= 3353) of 10 to 12 weeks in period. Quetiapine is not approved by the FDA for use in the treatment of behavioral disorders in senior patients with dementia.
An increased risk of death, possibly due to heart failure or abrupt death, has been reported with using atypical antipsychotic representatives in the treatment of behavioral disorders in the senior patient with dementia.
The results of a large retrospective mate research study appear to indicate that atypical antipsychotic representatives (i.e., risperidone, olanzapine, clozapine, quetiapine) increase the risk of venous thromboembolism in senior patients; nevertheless, these occasions appear to be rare.
Blood pressure elevations referred to 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 teenagers, respectively. One child with a history of hypertension experienced a hypertensive crisis.
QT periods have not been systematically assessed. During scientific trials, persistent increases in QT periods were not recognized; however there have been postmarketing reports of QT prolongation in patients who overdosed on this drug, in patients with concomitant health problem, and in patients taking drugs that are understood to cause electrolyte imbalance or QT interval prolongation.
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.
Unusual (0.1% to 1%): Bundle branch block.
Unusual (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.
Really unusual (less than 0.01%): Hypertensive crisis.
Frequency not reported: Cardiomyopathy, myocarditis, bradycardia, peripheral edema.
Postmarketing reports: QT prolongation
Endocrine
Typical (1% to 10%): Shifts in thyroid hormones and TSH, hyperprolactinemia, modified 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)
In adults, dose-related decreases in thyroid hormone levels have been observed. It appears that optimum reductions in overall and complimentary thyroxine (T4) take place in the first 6 weeks of treatment and are kept without adaptation or progression during chronic therapy. Upon therapy discontinuation, these results mainly return to standard worths. The mechanism by which this drug impacts the thyroid axis is uncertain.
Metabolic
Irregular antipsychotic drugs have been related to metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. While these results have been shown as a class result, each representative has its own profile.
Hyperglycemia: Adults: In controlled scientific trials of 12 weeks or less, 2.4% of patients with typical (less than 100 mg/dL) fasting plasma glucose (FPG) had at least 1 FPG reading of 126 mg/dL or higher (vs. placebo 1.4%) during treatment. For patients with baseline borderline to high FPG (100 mg/dL or greater), 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 standard in patients treated with quetiapine (mean exposure 213 days; n= 646) was 5 mg/dL (vs. placebo -0.05 mg/dL). Amongst patients with major depressive condition receiving the extended-release formulation of this drug, a FBG greater than 126 mg/dL happened in 7%, 12%, and 6% of those receiving 150 mg, 300 mg, or placebo.
Pediatrics: In a research 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 standard fasting glucose level lower than 126 mg/dL had a treatment-emergent blood glucose level greater than 126 mg/dL.
Dyslipidemia: Across signs, adult patients who experienced shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically substantial levels took place in as much as 18%, 22%, 6%, and 14% of patients getting this drug compared to as much as 7%, 16%, 5%, and 14% getting placebo, respectively. For pediatric patients, the shifts were up to 12%, 22%, 8%, and 15% compared to approximately 3%, 13%, 5%, and 19% for this drug and placebo, respectively.
Weight gain: Logistic regression analysis has actually revealed a positive dose action for weight gain. 5 to 10% of adult patients experienced a weight gain of 7% or higher (vs. as much as 5% in placebo). Among children and teenagers, a weight gain of 7% or higher took place in 7% to 21% of patients getting this drug compared with approximately 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 changed for typical growth.
Very common (10% or more): Hyperglycemia, increases in serum triglycerides, hyperlipidemia,
Typical (1% to 10%): Weight gain, increased hunger, 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
Dermatologic
Common (1% to 10%): Rash, sweating, acne.
Unusual (0.1% to 1%): Photosensitivity response, 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, hazardous epidermal necrolysis, drug response with eosinophilia and systemic symptoms (DRESS).
Respiratory
Typical (1% to 10%): Pharyngitis, rhinitis, sinusitis, nasal congestion, cough, sinus blockage, epistaxis, upper respiratory tract infection.
Unusual (0.1% to 1%): Pneumonia, asthma.
Unusual (0.01% to 0.1%): Hiccup, hyperventilation.
Frequency not reported: Dyspnea.
Other
Typical (1% to 10%): Pain, asthenia, fever, balance disorder.
Frequency not reported: Hypothermia, vertigo.
Hematologic
Very common (10% or more): Decreased hemoglobin.
Typical (1% to 10%): Decreased neutrophil count, leucopenia.
Unusual (0.1% to 1%): Leukocytosis, anemia, eosinophilia, lymphadenopathy, decreased platelets.
Unusual (0.01% to 0.1%): Agranulocytosis.
Frequency not reported: Leukopenia/neutropenia, eosinophilia.
Ocular
Common (1% to 10%): Amblyopia, blurred vision.
Unusual (0.1% to 1%): Conjunctivitis, abnormal vision, dry eyes, blepharitis, eye pain.
Uncommon (0.01% to 0.1%): Glaucoma.
Frequency not reported: Lens changes.
Genitourinary
Typical (1% to 10%): Urinary tract infection.
Unusual (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.
Musculoskeletal
Common (1% to 10%): Back pain, twitching, arthralgia, dysarthria, extremity pain, muscle rigidity, musculoskeletal tightness.
Uncommon (0.1% to 1%): Pathological fracture, myasthenia, leg cramps, bone pain.
Frequency not reported: Elevations in serum creatine phosphokinase (not connected with NMS).
Postmarketing reports: Rhabdomyolysis.
Kidney
Unusual (0.01% to 0.1%): Acute kidney failure.
Hepatic
Typical (1% to 10%): Increased ALT, increased AST.
Rare (0.01% to 0.1%): Jaundice, liver disease.
Frequency not reported: Gamma GT elevations.
Immunologic
Typical (1% to 10%): Infection, tooth abscess.
Frequency not reported: Influenza.
