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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: June 5, 2023.



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 disorder 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 with more than 10 million prescriptions filled yearly in the United States. Quetiapine is available as tablets of 25, 50, 100, 200, 300 and 400 mg generically and 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. Quetiapine like most atypical antipsychotic agents has a boxed warning for increased risk of death in patients with dementia-related psychosis, and like most potent antidepressants it has a boxed warning for suicidal thoughts and behaviors.


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 DRESS syndrome and 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 usually tolerate switching to others.

Drug Class: Antipsychotic Agents, Atypicals



Quetiapine – Generic, Seroquel®


Antipsychotic Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Quetiapine 111974-69-7 C21-H25-N3-O2-S image 135017541 in the ncbi pubchem database


References updated: June 6, 2023

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    (Review on efficacy and safety of quetiapine; “Mild, transient, reversible and asymptomatic elevations in the liver enzymes were seen in a small number of patients”).
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    (Editorial; quetiapine discovered in 1985 at AstraZeneca, approved in US for schizophrenia in 1997).
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    (Review of 9 clinical trials of quetiapine in patients with schizophrenia; ALT elevations occurred but were mild and reversible; ALT levels were >3 times ULN in 6% of quetiapine- vs 1% of placebo-recipients, usually within the first 3 weeks of treatment and without hepatitis or jaundice).
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    (Review of the interactions of the atypical antipsychotics with the P450 system; clozapine metabolized by CYP1A2 and 3A4 and possibly 2C9 and 2D6; risperidone by CYP2D6 and possibly 3A4; olanzapine by CYP1A2 and possibly 2D6; quetiapine and ziprasidone by CYP3A4).
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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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    (Prospective study of 67 patients started on atypical antipsychotics [9 on quetiapine]; ALT elevations were more frequent in 14 who gained >7% of body weight than in the 53 who did not [50% vs 19%] and mean changes in ALT, AST and GGT were greater in those who gained weight; all abnormalities were transient, asymptomatic and not associated with bilirubin elevations).
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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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    (Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008; several antidepressants [duloxetine, sertaline, fluoxetine, amitryptilline], but none of the atypical antipsychotic agents were implicated).
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    (77 year old woman developed fatigue and jaundice 9 days after starting quetiapine [bilirubin 4.8 mg/dL, ALT 1565 U/L, Alk P 178 U/L, INR 4.1], with subsequent multiorgan failure and death, despite improvement in liver tests).
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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 triglycerides [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).
  • Drugs for psychotic disorders. Med Lett Drugs Ther. 2016;58(1510):160–4. [PubMed: 27960194]
    (Concise review of medications available in the US for therapy of psychotic disorders; mentions that olanzapine can cause aminotransferase elevations, and that olanzapine and ziprasidone can cause DRESS syndrome, but does not mention ALT elevations or hepatotoxicity for any of agents discussed, including aripiprazole, brexpiprazole, cariprazine, clozapine, quetiapine, risperidone, asenapine, iloperidone, paliperidone and lurasidone).
  • 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).
  • Baeza I, de la Serna E, Calvo-Escalona R, Merchán-Naranjo J, Rodríguez-Latorre P, Martínez-Cantarero MC, Andrés P, et al. One-year prospective study of liver function tests in children and adolescents on second-generation antipsychotics: is there a link with metabolic syndrome? J Child Adolesc Psychopharmacol. 2018;28:463–73. [PubMed: 29975563]
    (Among 216 children and adolescents starting atypical antipsychotics, mean weight gain at 6 months was 6.5 kg and mean ALT levels increased by 8.6 U/L, while among 19 taking quetiapine for 6 months mean weight gain was 10.3 kg and ALT increase 42.5 U/L; increases in ALT associated most closely with development of the metabolic syndrome, mean ALT increasing by 27.8 U/L at 6 months).
  • Druschky K, Toto S, Bleich S, Baumgärtner J, Engel RR, Grohmann R, Maier HB, et al. Severe drug-induced liver injury in patients under treatment with antipsychotic drugs: data from the AMSP study. World J Biol Psychiatry. 2021;22:373–386. [PubMed: 32892689]
    (Among 246 cases of severe liver injury due to antipsychotic medications identified in a prospective registry of German psychiatric hospitals between 1993 and 2016, 46 arose in 38,349 patients [0.12%] who received clozapine [34 as a single antipsychotic agent]; other commonly implicated agents being olanzapine [n=90 of 54,822: 0.16%], quetiapine [34 of 66,209: 0.05%] and risperidone [27 of 51,683: 0.05%]; two fatal cases occurred in olanzapine-treated patients).
  • Zeiss R, Hafner S, Schönfeldt-Lecuona C, Connemann BJ, Gahr M. Drug-associated liver injury related to antipsychotics: exploratory analysis of pharmacovigilance data. J Clin Psychopharmacol. 2022;42:440–444. [PubMed: 35730552]
    (Review of the VigiBase data base of individual case safety reports on antipsychotics and liver injury found positive hepatic safety signals for olanzapine and clozapine, but none for risperidone, quetiapine, ziprasidone, asenapine, aripiprazole, brexpiprazole, and cariprazine).
  • Gunther M, Dopheide JA. Antipsychotic safety in liver disease: a narrative review and practical guide for the clinician. J Acad Consult Liaison Psychiatry. 2023;64:73–82. [PubMed: 36180017]
    (Review of the literature on hepatotoxicity of antipsychotic medications and guidance on their use in patients with liver disease characterizes chlorpromazine, clozapine, and olanzapine as having the greatest risk for causing liver injury, quetiapine and risperidone as having moderate risk, haloperidol as having low risk and paliperidone, aripiprazole, lurasidone, and loxapine as having low risk).


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