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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: May 15, 2018.



Quetiapine is an atypical antipsychotic used in the treatment of schizophrenia and bipolar disorder. Use of quetiapine has been associated with serum aminotransferase elevations and in rare instances with clinically apparent acute liver injury.


Quetiapine (kwe tye' a peen) is an atypical antipsychotic and dibenzodiazepine derivative which appears to act as a dopamine (D1-4) and serotonin (5-HT2) receptor antagonist. It also may have activity against histamine and alpha adrenergic receptors. Quetiapine is indicated for the treatment of schizophrenia and as either monotherapy or adjunctive therapy for acute manic episodes or as maintenance therapy in bipolar I disorder. It is also used in treatment of depressive episodes associated with bipolar I or II disorde and for major depressive disorders in combination with antidepressants. Quetiapine was approved for use in the United States in 1997 and is still widely used. Quetiapine is available as tablets of 25, 50, 100, 200, 300 and 400 mg under the brand name Seroquel. Typical doses vary from 300 to 800 mg daily given in two divided doses. Extended release forms are also available for once daily dosing. Common side effects include dizziness, sedation, somnolence, dry mouth, constipation, weakness, postural hypotension, increased appetite and weight gain. Rare, but potentially severe adverse events include neuroleptic malignant syndrome, tardive dyskinesia, severe dyslipidemia, diabetes, weight gain, hypotension, bone marrow suppression and cataracts.


Liver test abnormalities may occur in up to 30% of patients on long term therapy with quetiapine, but elevations are uncommonly above 3 times the upper limit of normal. The aminotransferase abnormalities are usually mild, asymptomatic and transient, reversing even with continuation of medication. Instances of clinically apparent acute liver injury have been reported due to quetiapine, but they are rare. The onset of jaundice is within 1 to 4 weeks of starting the drug, and the pattern of serum enzyme elevations is typically hepatocellular. Signs of immunoallergic manifestations (fever, rash and eosinophilia) are rare, as are autoantibodies. Most cases are mild to moderate in severity and self-limited in course. Instances of acute liver failure have been reported but not vanishing bile duct syndrome or chronic liver injury.

Likelihood score: B (likely but rare cause of clinically apparent liver injury).

Mechanism of Injury

The mechanism by which quetiapine causes serum aminotransferase elevations is not known, but is likely due to production of a toxic intermediate by its metabolism. Quetiapine is extensively metabolized by the liver via sulfoxidation and oxidation, partially via CYP 3A4. Some instances of serum aminotransferase elevations occurring on quetiapine therapy may be due to nonalcoholic fatty liver disease caused by weight gain that occurs in at least one-quarter of treated patients, generally during the first 1 to 2 years of therapy.

Outcome and Management

The serum aminotransferase elevations that occur on quetiapine therapy are usually self-limited and usually do not require dose modification or discontinuation of therapy. Cases of clinically apparent liver injury are usually mild to moderate in severity and self-limited course. Rare instances of acute liver failure due to quetiapine have been reported, but it has not been implicated in cases of chronic liver disease or vanishing bile duct syndrome. Patients with quetiapine induced liver injury may have cross sensitivity to other atypical antipsychotics (risperidone) but may tolerate others.

Drug Class: Antipsychotic Agents, Atypicals



Quetiapine – Seroquel®


Antipsychotic Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Quetiapine Chemical Structure


References updated: 15 May 2018

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    (58 year old woman developed jaundice 1 month after starting quetiapine [bilirubin 17.3 mg/dL, ALT 1245 U/L, Alk P 265 U/L, ANA 1:2560], progressing to liver failure and death within 21 days; autopsy showed massive necrosis).
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    (Three cases of overdose with quetiapine, 39-56 year olds, found dead at home soon after overdose; respiratory arrest; no information on hepatic injury).
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    (30 year old man developed jaundice after being on risperidone and lithium for 8 years [bilirubin 4.7 mg/dL, ALT 99 U/L, Alk P 267 U/L], resolving with change of risperidone to ziprasidone, but 1 year later developed recurrent jaundice 3 weeks after starting quetiapine, having tolerated olanzapine).
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    (Retrospective analysis on 194 patients; ALT levels were >3 times ULN in 27% often in first month; among 48 receiving quetiapine, 27% had ALT elevations, 23% at 6 months, but they were modest and none had elevations greater than 3 fold).
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    (Review of frequency of weight gain in patients treated for bipolar disorders, most weight gain occurred with clozapine and olanzapine, but some weight gain also with quetiapine, risperidone, lithium, valproate and gabapentin; not with aripiprazole, ziprasidone, carbamazepine or lamotrigine).
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    (21 year old man developed jaundice 10 days after starting quetiapine [bilirubin 14.7 mg/dL, ALT 2582 U/L, Alk P 167 U/L, ANA negative, prolonged INR], resolving completely with stopping).
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    (59 year old woman developed weakness 3 weeks and jaundice 6 weeks after starting quetiapine [bilirubin 14.3 mg/dL, ALT 711 U/L, Alk P 196 U/L, INR 2.7], with signs of hepatic failure, but ultimate slow recovery after stopping).
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    (Among 39,728 patients treated with psychiatric medications in Swiss hospitals between 2001 and 2010 who were monitored in a drug surveillance program, rates of severe adverse events were similar in those above and below the age of 60 [1.6% vs 1.8%], although weight gain and ALT elevations were less frequent in the elderly [details not provided]).
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    (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, but none were attributed to quetiapine or other atypical antipsychotic agents).
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    (Among 90 patients with bipolar disorder with depression and alcohol dependence who were treated with quetiapine or placebo for 12 weeks, alcohol use was similar in the two groups; ALT levels were not mentioned, but there were no liver related serious adverse events).
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    (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, none of which were attributed to quetiapine or other atypical antipsychotic medications).
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    (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 3 of which were attributed to quetiapine).
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    (Among 218 adults with alcohol dependence treated with quetiapine or placebo for 12 weeks, there was a moderate increase in the likelihood of having ALT elevations in quetiapine treated subjects with and without preexisting elevations, although the differences [not provided] were judged to be "not clinically significant in that they required no medical management").
  • Morlán-Coarasa MJ, Arias-Loste MT, Ortiz-García de la Foz V, Martínez-García O, Alonso-Martín C, Crespo J, Romero-Gómez M, et al. Incidence of non-alcoholic fatty liver disease and metabolic dysfunction in first episode schizophrenia and related psychotic disorders: a 3-year prospective randomized interventional study. Psychopharmacology (Berl) 2016; 233: 3947-52. [PubMed: 27620899]
    (Among 191 schizophrenic patients treated with an atypical antipsychotic agent for at least 3 years, surrogate markers for steatosis arose in 48 [25%], most of whom had a 7% increase in body weight [n=44: 92%], increase in trigylercides [54%], total cholesterol [52%], and waist circumference [68%]; changes in regard to fatty liver did not vary by specific antipsychotic agent [46 received quetiapine]).
  • Hayes JF, Marston L, Walters K, Geddes JR, King M, Osborn DP. Adverse renal, endocrine, hepatic, and metabolic events during maintenance mood stabilizer treatment for bipolar disorder. PLoS Med 2016; 13: e1002058. [PMC free article: PMC4970809] [PubMed: 27483368]
    (Analysis of UK electronic health data on patients with bipolar disorder between 1995 and 2013, found greater than 15% weight gain to be higher with valproate [Hazard Ratio: HR=1.6], olanzapine [HR=1.8], quetiapine [HR=1.7] compared to lithium alone).
  • Das A, Guarda LA, Allen LG. Liver injury associated with quetiapine: an illustrative case report. J Clin Psychopharmacol 2017; 37: 623-5. [PubMed: 28786826]
    (45 year old woman developed jaundice a year after starting and 3 weeks after increasing the dose of quetiapine [bilirubin 18.2 mg/dL, ALT 95 U/L, Alk P 267 U/L, INR 1.45], which improved on stopping, but documentation not provided).


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