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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 4, 2018.



Risperidone is an atypical antipsychotic that is used widely in the treatment of mania and schizophrenia. Risperidone therapy is associated with serum aminotransferase elevations and in rare instances has been linked to clinically apparent acute liver injury.


Risperidone (ris per' i done) is a benzisoxazole derivative which appears to act as a dopamine type 2 (D2) and serotonin (5-HT2) receptor antagonist. Risperidone is indicated for treatment of schizophrenia and as monotherapy or combination therapy for acute manic or mixed episodes of bipolar I disorder in adults. Risperidone is also used for management of irritability with autistic disorder in children and adolescents. Risperidone was approved for use in the United States in 1993 and it is still widely used. Risperidone is available as tablets of 0.25, 0.5, 1, 2, 3 and 4 mg generically and under the brand name of Risperdal. Oral solutions for pediatric use are available as are orally disintegrating tablets and formulations for parenteral administration. The typical initial dose in adults is 1 mg once or twice daily, with increase in dose to as high as 8 mg daily based upon indications, efficacy and tolerance. Common side effects include somnolence, fatigue, restlessness, dizziness, dry mouth, increased saliva, constipation, increased appetite and weight gain. Rare, but potentially severe adverse events include cerebrovascular events, tardive dyskinesia, neuroleptic malignant syndrome, orthostatic hypotension, suicidal ideation and behavior, seizures, diabetes and agranulocytosis.


Liver test abnormalities may occur in up to 30% of patients on long term therapy with risperidone, usually arising within the first 8 weeks of treatment. The ALT elevations are usually mild, transient and may resolve even with continuation of medication. Instances of more marked ALT and alkaline phosphatase elevations, with or without symptoms and with or without jaundice, have also been reported. The onset of injury typically occurs within a few days of starting risperidone and resolves rapidly with stopping. Instances of acute liver injury with jaundice arising several months and even years after starting risperidone have also been reported. The pattern of serum enzyme elevations is typically cholestatic, but cases with hepatocellular and mixed patterns have also been described. Immunoallergic manifestations (rash, fever, eosinophilia) are rare; a case of autoimmune hepatitis apparently triggered by risperidone therapy was been published, but most cases do not have autoimmune features.

Likelihood score: C (probable rare cause of clinically apparent liver injury).

Mechanism of Injury

The mechanism by which risperidone causes serum ALT elevations is not known. Risperidone is extensively metabolized by the cytochrome P450 system (CYP 2D6) to its active metabolite. Some instances of liver injury may be due to nonalcoholic fatty liver disease caused by weight gain that occurs in at least one-quarter of treated patients and can be as much as 30 kg, generally during the first 1 to 2 years of therapy. In large series, however, the minor ALT elevations that occur on therapy have not correlated well with weight gain.

Outcome and Management

The serum aminotransferase elevations that occur on risperidone therapy are usually self-limited and often do not require dose modification or discontinuation of therapy. No instances of acute liver failure or vanishing bile duct syndrome have been attributed to risperidone. A single case of autoimmune hepatitis due to risperidone has been published. There may be some cross reactivity to liver injury between risperidone and quetiapine, but usually not with clozapine and olanzapine.

Drug Class: Antipsychotic Agents, Atypicals



Risperidone – Generic, Risperdal®


Antipsychotic Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Risperidone Chemical Structure


References updated: 04 June 2018

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    (37 year old man developed rises in ALT [140 U/L] and GGT [260 U/L] within days of starting risperidone, that continued on haloperidol [ALT 100 U/L] and olanzapine [ALT 160 U/L]; peak bilirubin 1.6 mg/dL; biopsy showed “cholestatic hepatitis”; tests fell to normal ~1 month after discontinuation).
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    (32 year old man developed abdominal pain and jaundice 1 week after starting risperidone [bilirubin 2.8 mg/dL, ALT 366 U/L, Alk P 367 U/L, amylase 1617 U/L], resolving rapidly with stopping).
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    (23 hospitalized patients on atypical antipsychotics, 6 had ALT or AST elevations by day 14, ALT 48-158 U/L, 2 on risperidone, 2 on olanzapine and one on amisulpride; 1 on risperidone required discontinuation).
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    (51 year old man developed jaundice after 4 years of risperidone therapy [bilirubin 2.5 mg/dL, AST 49 U/L, normal Alk P and GGT], possibly representing Gilbert syndrome and minor AST elevations from risperidone; unclear whether abnormalities resolved on stopping).
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    (28 year old man developed enzyme elevations 7 weeks and symptoms 8 weeks after starting risperidone [bilirubin normal, ALT 522 U/L], resolving within 3 weeks of stopping; smooth muscle antibody positive).
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    (36 year old woman developed jaundice 10 days after starting risperidone [bilirubin rising from 15 to 29 mg/dL, ALT 818 U/L, Alk P 627 U/L, ANA of 1:320]; ALT continued to rise for 3 weeks [peak 1185 U/L] and prednisone was started with rapid response, but relapse [ALT 843 U/L, ANA 1:1280] when corticosteroids stopped, biopsy showing features of autoimmune hepatitis which was again controlled by prednisone and later with azathioprine alone).
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    (Trial of 3 weeks of olanzapine [n=165] vs risperidone [n=164] for bipolar illness; greater weight gain [16% vs 4%] and ALT elevations [mean increase 15.7 U/L vs 1 U/L] with olanzapine).
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    (Prospective study of 67 patients started on atypical antipsychotics [10 on risperidone]; ALT elevations were more frequent in 14 patients who gained >7% of body weight than in 53 who did not [50% vs 19%] and mean changes in ALT, AST and GGT were greater; all were transient, asymptomatic and not associated with bilirubin elevations).
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    (30 year old man developed jaundice after 8 years of therapy with risperidone and lithium [bilirubin 4.7 mg/dL, ALT 99 U/L, Alk P 267 U/L], resolving with change of risperidone to ziprasidone, but recurring 3 weeks after starting quetiapine, after tolerating olanzapine).
  • Atasoy N, Erdogan A, Yalug I, Ozturk U, Konuk N, Atik L, Ustundag Y. A review of liver function tests during treatment with atypical antipsychotic drugs: a chart review study. Prog Neuropsychopharmacol Biol Psychiatry 2007; 31: 1255-60. [PubMed: 17600607]
    (Retrospective analysis on 194 patients on atypical antipsychotics; ALT >3 times ULN occurred in 27%, often in first month; among 29 receiving risperidone, 28% had ALT elevations, but elevations were modest and none >3 times ULN).
  • Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, et al. Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-affective disorder: findings from the treatment of early-onset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry 2008; 165: 1420-31. [PubMed: 18794207]
    (Prospective trial of molindone [1st generation antipsychotic agent] vs olanzapine or risperidone [2nd generation agents] for schizophrenia in 199 youths found similar rates of efficacy [34-50%], but more weight gain [mean 6.1 kg] and ALT elevations with olanzapine).
  • Erdogan A, Atasoy N, Akkurt H, Ozturk D, Karaahmet E, Yalug I, Yalug K, et al. Risperidone and liver function tests in children and adolescents: a short-term prospective study. Prog Neuropsychopharmacol Biol Psychiatry 2008; 32: 849-57. [PubMed: 18258348]
    (Among 120 children and adolescents prospectively followed for one month on risperidone therapy, 52.5% had mild ALT elevations, but only 1 subject had ALT >3 times ULN [ALT 225 U/L, Alk P 641 U/L, bilirubin 0.4 mg/dL], resolving with discontinuation; no correlation with weight gain, which occurred in 57%).
  • Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34. [PMC free article: PMC3654244] [PubMed: 18955056]
    (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).
  • Torrent C, Amann B, Sanchez-Moreno J, Colom F, Feinares M, Comes M, Rosa AR, et al. Weight gain in bipolar disorder: pharmacological treatment as a contributing factor. Acta Psychiatr Scand 2008; 118: 4-18. [PubMed: 18498432]
    (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).
  • Parsons B, Allison DB, Loebel A, Williams K, Giller E, Romano S, Siu C. Weight effects associated with antipsychotics: a comprehensive database analysis. Schizophr Res 2009; 110: 103-10. [PubMed: 19321312]
    (Analysis of weight gain in 21 placebo controlled trials [~3300 patients]; average monthly weight gain in pounds was +0.1 with placebo, +0.8 olanzapine, 0.6 risperidone, -0.3 ziprasidone; a 5% increase in weight occurred after one year in 13% of placebo, 39% haloperidol, 20% ziprasidone, 45% risperidone and 60% olanzapine treated subjects).
  • Paulzen M, Orfanos S, Gründer G. Remission of drug-induced hepatitis after switching from risperidone to paliperidone. Am J Psychiatry 2010; 167: 351-2. [PubMed: 20194492]
    (43 year old woman with schizophrenia developed jaundice on risperidone and clozapine therapy [bilirubin not given, ALT 75 U/L, Alk P 6 times ULN], improving on switching from risperidone to paliperidone and lowering clozapine dosage).
  • Lin CH, Kuo CC, Chou LS, Chen YH, Chen CC, Huang KH, Lane HY. A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in treating schizophrenia. J Clin Psychopharmacol 2010; 30: 518-25. [PubMed: 20814315]
    (Controlled trial of 6 weeks of risperidone alone vs lower dose risperidone and haloperidol in 88 patients with schizophrenia; no change in mean ALT or AST levels in either group and no mention of hepatotoxicity).
  • Erdogan A, Karaman MG, Ozdemir E, Yurteri N, Tufan AE, Kurcer MA. Six months of treatment with risperidone may be associated with nonsignificant abnormalities of liver function tests in children and adolescents: a longitudinal, observational study from Turkey. J Child Adolesc Psychopharmacol 2010; 20: 407-13. [PubMed: 20973711]
    (Among 102 children or adolescents [ages 2-18 years] treated with risperidone for more than 6 months, serum enzyme elevations occurred in 38%, but were usually transient and mild and isolated Alk P elevations only; only one child had ALT rise above twice normal [ALT 225 U/L, GGT 27 U/L, bilirubin 0.5 mg/dL], which resolved within one month of stopping; weight gain averaged 5.5 kg at 6 months).
  • Karaman MG, Erdoğan A, Tufan E, Yurteri N, Ozdemir E, Ankarali H. Liver function tests in children and adolescents receiving risperidone treatment for a year: a longitudinal, observational study from Turkey. Int J Psychiatry Clin Pract 2011; 15: 204-8. [PubMed: 22121930]
    (Among 100 children or adolescents treated with risperidone for more than 6 months, liver tests were abnormal in 21%, but none had symptoms and only one child had an ALT level above 3 times ULN, which resolved rapidly upon stopping).
  • Copur M, Erdogan A. Risperidone rechallenge for marked liver function test abnormalities in an autistic child. Recent Pat Endocr Metab Immune Drug Discov 2011; 5: 237-9. [PubMed: 21913889]
    (5 year old boy with autism was found to have elevations in serum enzymes during risperidone therapy, which resolved on stopping, but did not recur when risperidone was restarted).
  • Greil W, Häberle A, Schuhmann T, Grohmann R, Baumann P. Age and adverse drug reactions from psychopharmacological treatment: data from the AMSP drug surveillance programme in Switzerland. Swiss Med Wkly 2013; 143: w13772. (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]).
  • López-Torres E, Süveges A, Peñas-LLedó EM, Doña A, Dorado P, LLerena A, Berecz R. Liver enzyme abnormalities during antipsychotic treatment: a case report of risperidone-associated hepatotoxicity. Drug Metabol Drug Interact 2014; 29: 123-6. [PubMed: 24598833]
    (19 year old man with schizophrenia developed fatigue and weight loss 3 weeks after starting risperidone [bilirubin normal, ALT 778, Alk P normal], resolving within 2 months of stopping).
  • Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol 2014; 13: 231-9. [PubMed: 24552865]
    (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, but none were attributed to risperidone or other atypical antipsychotic medications).
  • Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52.e7. [PMC free article: PMC4446235] [PubMed: 25754159]
    (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, five were attributed to atypical antipsychotics [3 quetiapine, 2 olanzapine], but none to risperidone).
  • 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 and ziprasidone can cause DRESS syndrome, but does not mention ALT elevations or hepatotoxicity for any of the agents discussed).
  • 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 [12 received risperidone]).
  • Saglam O, Bahsi R, Akkoca Y, Filik L. Risperidone-induced hepatotoxicity in a patient addicted to synthetic cannabinoid. Eur J Gastroenterol Hepatol 2016; 28: 360-1. [PubMed: 26825144]
    (31 year old man developed fatigue 3 months after starting risperidone to treat cannabinoid addiction [bilirubin 2.3 mg/dL, ALT 890 U/L, Alk P 736 U/L], resolving within 2 weeks of stopping).


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