Quetiapine Side Effects

Brand Names: Seroquel, Seroquel XR

Please note - some side effects for Quetiapine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Quetiapine - for the Consumer

Quetiapine

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Quetiapine:

Constipation; dizziness; drowsiness; dry mouth; lightheadedness; nasal congestion; sore throat; stomach pain or upset; tiredness; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, stiffness, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, depression, exaggerated feeling of well-being, hallucination, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); numbness or tingling; persistent, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, jerking or twisting, twitching of the face or tongue); vision changes.

Quetiapine Sustained-Release Tablets

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Quetiapine Sustained-Release Tablets:

Constipation; dizziness; drowsiness; dry mouth; lightheadedness; stomach upset; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, stiffness, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, depression, exaggerated feeling of well-being, hallucination, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); numbness or tingling; persistent, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, jerking or twisting, twitching of the face or tongue); vision changes.

Side Effects by Body System

Nervous system

Nervous system side effects have included agitation (20%), somnolence (18%), dizziness (11%), tremor (8%), and anxiety (4%). Hypertonia, dysarthria, abnormal dreams, dyskinesia, abnormal thinking, tardive dyskinesia, vertigo, involuntary movements, confusion, amnesia, hyperkinesia, increased libido, incoordination, abnormal gait, myoclonus, apathy, ataxia, stupor, bruxism, hemiplegia, aphasia, buccoglossal syndrome, choreoathetosis, delirium, decreased libido, neuralgia, stuttering, akathisia, dystonia, parkinsonism, and subdural hematoma have also been reported; however, causality has not been established. Two cases of neuroleptic malignant syndrome that may possibly have been related to quetiapine use have also been reported. One case of quetiapine-associated restless leg syndrome has been reported.

Nervous system side effects specifically associated with the extended-release tablets have included sedation (13%), somnolence (12%), and dizziness (10%).

Gastrointestinal

Gastrointestinal side effects have included dry mouth (9%), constipation (8%), vomiting (6%), dyspepsia (5%), gastroenteritis (2%), and increased gamma glutamyl transpeptidase level (1%). Anorexia, increased salivation, increased appetite, gingivitis, dysphagia, flatulence, gastroenteritis, gastritis, hemorrhoids, stomatitis, thirst, tooth caries, fecal incontinence, gastroesophageal reflux, gum hemorrhage, mouth ulceration, rectal hemorrhage tongue edema, glossitis, hematemesis, intestinal obstruction, melena, and pancreatitis have also been reported; however, causality has not been established.

Gastrointestinal side effects specifically associated with the extended-release tablets have included dry mouth (12%), constipation (6%), and dyspepsia (5%).

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.

Cardiovascular side effects have included tachycardia (6%), postural hypotension (4%), and palpitation. Vasodilatation, QT interval prolongation, bradycardia, cerebral ischemia, irregular pulse, T wave abnormality, bundle branch block, cerebrovascular accident, venous thromboembolism, T wave inversion, anginal pectoris, atrial fibrillation, first degree atrioventricular (AV) block, congestive heart failure, elevated ST, thrombophlebitis, T wave flattening, ST abnormality, cardiomyopathy (including fatal cardiomyopathy), myocarditis, and increased QRS duration have also been reported.

Cardiovascular side effects specifically associated with the extended-release tablets have included orthostatic hypotension (7%).

Endocrine

Endocrine side effects have included hypothyroidism, diabetes mellitus, and hyperthyroidism. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) has also been associated with quetiapine use.

A study of U.S. military veterans with schizophrenia has reported that patients on quetiapine had 3.34 times as many cases of diabetes when compared to patients taking decades old drugs for psychosis including haloperidol, thioridazine, and others.

Additional studies have confirmed that patients receiving atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) are at an increased risk of developing hyperglycemia and/or diabetes mellitus.

Treatment with quetiapine has been shown to cause significant decreases in total serum thyroxine (T4) and triiodothyronine (T3) levels and a significant increase in thyroid-stimulating hormone (TSH) levels after 6 weeks of therapy.

Metabolic

Metabolic side effects have included weight gain, increased SGPT, and increased SGOT in 5% of patients. Weight loss, hyperglycemia, and hypoglycemia have been reported infrequently.

Treatment with quetiapine has been associated with moderate weight gain. Most of the weight gain (greater than 60%) appears to occur within the first 12 weeks of therapy with modest changes occurring after 6 months. In one study, the mean weight gain after 1 and 2 years of treatment with quetiapine was 3.19 kg (7 lbs) and 5.16 kg (11 lbs), respectively. The weight gain reported with quetiapine does not appear to be dose-related.

Dermatologic

Dermatologic side effects have included rash (4%) and sweating. Pruritus, acne, eczema, contact dermatitis, maculopapular rash, seborrhea, skin ulcer, exfoliative dermatitis, psoriasis, and skin discoloration have also been reported; however, causality has not been established. A rare case of erythema multiforme minor, that resolved following discontinuation of quetiapine, has been reported.

Respiratory

Respiratory side effects have included pharyngitis (6%) and rhinitis (3%). Increased cough, dyspnea, pneumonia, epistaxis, asthma, hiccup, and hyperventilation have also been reported; however, causality has not been established. A single case of hyperventilation and respiratory alkalosis has been reported. One case of acute respiratory failure has been reported.

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. 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 an infection, such as pneumonia, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

A case of acute respiratory failure has been reported in a patient with COPD following a single oral dose of 50 mg.

Other

Other side effects have included headache (21%), pain (7%), asthenia (5%), abdominal pain (4%), back pain (3%), fever (2%), and ear pain (1%). Flu syndrome, neck pain, pelvic pain, suicide attempt, malaise, photosensitivity reaction, chills, face edema, moniliasis, enlarged abdomen, migraine, peripheral edema, increased alkaline phosphatase level, hyperlipemia, alcohol intolerance, dehydration, increased creatinine, glycosuria, gout, hand edema, hypokalemia, tinnitus, deafness, and water intoxication have also been reported; however, causality has not been established.

Hematologic

Hematologic side effects have included leukopenia, leukocytosis, anemia, ecchymosis, eosinophilia, hypochromic anemia, lymphadenopathy, cyanosis, hemolysis, and thrombocytopenia; however, causality has not been established. In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed. A single case of thrombotic thrombocytopenic purpura has been reported.

Ocular

One case of photopsia associated with high-dose quetiapine (1000 mg daily) has been reported. Symptoms resolved following a reduction in dose (900 mg daily).

Ocular side effects have included amblyopia (2%). Conjunctivitis, abnormal vision, dry eyes, blepharitis, eye pain, abnormality of accommodation, and glaucoma have also been reported; however, causality has not been established. One case of cataracts has been reported. One case of photopsia has been reported.

Genitourinary

A 48- year- old female with no prior history of urinary retention presented to the emergency room unable to void several months after initiating treatment with quetiapine. The patient self prescribed an increase in dosage from 900 mg/day to 1800 mg/day several weeks prior to this incident. Ten days prior to the visit to the emergency department she increased dosage again to 2400 mg/day. The urinary retention resolved within 48 hours of decreasing dosage back to the prescribed 900 mg/day. Urinary hesitancy developed again two months later after the patient again increased her dosage to 1800 mg/day without medical advice. The condition again resolved following a return to a dosage of 900 mg/day.

Genitourinary side effects have included dysmenorrhea, vaginitis, urinary incontinence, metrorrhagia, impotence, dysuria, vaginal moniliasis, abnormal ejaculation, cystitis, urinary frequency, amenorrhea, female lactation, leukorrhea, vaginal hemorrhage, vulvovaginitis, orchitis, gynecomastia, nocturia, and polyuria; however, causality has not been established. Rare cases of priapism have been reported with quetiapine use.

Musculoskeletal

Musculoskeletal side effects have included pathological fracture, myasthenia, twitching, arthralgia, arthritis, leg cramps, and bone pain; however, causality has not been established. Rare cases of rhabdomyolysis have been reported.

Two cases of rhabdomyolysis have been reported. One case occurred as a result of a quetiapine overdose and the second occurred after 14 days of quetiapine therapy (25 mg/day). In the second case, elevated serum creatinine kinase and liver enzyme levels gradually returned to normal following discontinuation of quetiapine.

Psychiatric

Psychiatric side effects have included psychosis, hallucinations, paranoid reactions, delusions, manic reaction, depersonalization, catatonic reaction, emotional lability, suicide attempt, and euphoria.

Renal

Renal side effects have included acute kidney failure; however, causality has not been established.

Hepatic

A 30-year-old patient experienced acute symptoms of cholestasis after 8 years of risperidone therapy. Once the drug was discontinued, the symptoms resolved completely. Eleven months later, quetiapine was introduced and the patient once again developed acute symptoms of cholestasis which later resolved after quetiapine discontinuation.

Hepatic side effects including at least one case of delayed-onset cholestasis have been reported.

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