risperidone (Risperdal)

the boxed warning: deaths among older people with dementia-related psychosis

the boxed warning says that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, and that risperidone is not approved for them [label, boxed warning and 5.1]. the number behind it is a pooled analysis of 17 placebo-controlled trials, mostly of atypical antipsychotics and mostly about 10 weeks long: about 4.5% died on drug against about 2.6% on placebo, 1.6 to 1.7 times the rate, mostly from cardiovascular causes such as heart failure or sudden death, or infectious ones such as pneumonia [label 5.1; fda-dementia]. the library row that explains this warning was written from the risperdal label itself, because the fda first applied it to risperidone and the other newer antipsychotics in 2005 and extended it to the older drugs in 2008 [fda-dementia].

two risperidone-specific facts sit beside the class number. in two of four placebo-controlled trials in elderly people with dementia, death was more common in people taking risperidone with the diuretic furosemide than on risperidone alone or on placebo with furosemide; the label says no mechanism has been identified and no consistent cause of death was seen [label 5.1]. and in the risperidone trials in that group (mean age 85), strokes and transient ischaemic attacks, including fatal ones, were significantly more common than on placebo [label 5.2]. the label also notes that people with parkinson’s disease or dementia with lewy bodies are unusually sensitive to it, with confusion, falls and features resembling neuroleptic malignant syndrome [label 8.8].

risperidone does not carry the antidepressant suicidality boxed warning, because it is not approved for depression. its label has no section on suicidality at all; the quetiapine and lurasidone explainers on this site explain that warning for the antipsychotics that do carry it [quetiapine-explainer].

prolactin, gynecomastia and lactation, with the label’s numbers

warning 5.6 says that, like other drugs that block dopamine d2 receptors, risperidone raises prolactin, that the elevation persists during chronic use, and that risperidone "is associated with higher levels of prolactin elevation than other antipsychotic agents" [label 5.6]. high prolactin can suppress the hormones that run the reproductive system, and the label lists what has been reported with prolactin-raising drugs: milk production (galactorrhea), missed periods (amenorrhea), breast enlargement in males (gynecomastia) and impotence. long-standing high prolactin with low sex hormones may lower bone density in women and men. the label adds that about a third of human breast cancers are prolactin-dependent in laboratory culture, that risperidone caused pituitary, mammary and pancreatic tumours in mice and rats, and that published studies of a link between high prolactin and breast cancer in people "have shown inconsistent results" [label 5.6]. it says the rise may reversibly reduce fertility in women [label 8.3].

the numbers are in the pediatric section. in placebo-controlled trials of up to 8 weeks in children aged 5 to 17 with autism or other psychiatric disorders, 49% on risperidone had a raised prolactin level against 2% on placebo; in children and adolescents with bipolar disorder or schizophrenia, 82% to 87% against 3% to 7%. the rise was dose-dependent and generally larger in girls [label 8.4]. across 1,885 children and adolescents in the trials, galactorrhea was reported in 0.8% and gynecomastia in 2.3% [label 8.4]. the label states that "the long-term effects of risperidone on growth and sexual maturation have not been fully evaluated in children and adolescents", and reports that in young dogs bone length and density fell and sexual maturation was delayed at every dose, with little or no reversal in females after 12 weeks off the drug [label 8.4]. the adult sections give no prolactin percentage; the patient counselling section tells prescribers to counsel every patient on the signs and to seek attention for amenorrhea or galactorrhea in women and erectile dysfunction or gynecomastia in men [label 17]. the label adds no rate for how often gynecomastia reverses, and neither does this page.

the court record on this warning is on the legal and safety record page linked in the sources, not here [legal-record].

the metabolic warning, with the label’s tables

warning 5.5 is the class warning that atypical antipsychotics cause hyperglycemia and diabetes, undesirable lipid changes and weight gain, that each drug has its own profile, and that fasting glucose should be tested at the start and periodically in anyone with diabetes risk factors, with regular weight monitoring [label 5.5]. risperidone’s tables are in the middle of the class: more than lurasidone’s, far less than olanzapine’s, and the label’s own one-year figures are the ones that matter.

• weight, adults [5.5, table 6]: in 7 placebo-controlled trials of 3 to 8 weeks, mean change was +0.7 kg at 1 to 8 mg and +2.2 kg above 8 mg against -0.3 kg on placebo; 8.7% and 20.9% gained 7% or more of body weight against 2.9%. in longer studies, mean gain was 4.3 kg at 24 weeks (395 people) and 5.3 kg at 48 weeks (203).
• weight, children and adolescents [5.5, table 7; 8.4]: in 9 placebo-controlled trials of 3 to 8 weeks, +2.0 kg against +0.6 kg, with 32.6% gaining 7% or more against 6.9%. in the open-label extensions, mean gain was 5.5 kg at 24 weeks (748 children) and 8.0 kg at 48 weeks (242). in 103 adolescents with schizophrenia the mean gain was 9.0 kg over 8 months, moving the average from the 56th to the 72nd weight percentile; in children with autism and other disorders, 7.5 kg over 12 months against an expected 3 to 3.5 kg of normal growth, with most of the gain in the first 6 months. the label says pediatric weight gain "should be assessed against that expected with normal growth".
• blood sugar [5.5, tables 2 and 3]: in adults, mean random glucose changed by +0.8 and +0.6 mg/dl against -1.4, and shifts from under 140 to 200 mg/dl or more were 0.4% and 0% against 0.6%; at 48 weeks the mean change was +4.1 mg/dl (50 people). in children, +2.6 against -1.3 mg/dl over 3 to 6 weeks, one child in 120 crossing 126 mg/dl, and +5.2 mg/dl at 24 weeks. the label reports extreme hyperglycemia with ketoacidosis, coma or death across the class, including risperidone, and diabetic ketoacidosis and hypoglycemia among post-marketing reports [label 5.5; 6.2].
• lipids [5.5, tables 4 and 5]: in adults, cholesterol changed by +6.9 and +1.8 mg/dl against +0.6, and 4.3% and 6.3% crossed 240 mg/dl against 2.7%; triglycerides fell on every arm. at 24 and 48 weeks, non-fasting cholesterol was up 4.4 and 5.5 mg/dl, and triglycerides up 19.9 at 24 weeks. in children, 7.1% crossed 200 mg/dl triglycerides against 1.5%, and 10% shifted to a low hdl against 0%, from small numbers.

movement side effects, dose, and the other warnings in plain words

the label is unusually direct about dose. for adults with schizophrenia, "doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended" [label 2.1]. for adolescents, no additional benefit above 3 mg; for children with mania, none above 2.5 mg, with more adverse events at higher doses [label 2.1, 2.2]. the dose-response tables say the same: in an 8-week trial of 2, 6, 10 and 16 mg, extrapyramidal symptoms were reported by 17%, 21%, 21% and 35% against 13% on placebo; in a trial of 1 to 16 mg, by 7% rising to 20% [label 6.1, tables 16 and 17]. in the adult schizophrenia trials, parkinsonism (stiffness, slowness, tremor) was 14% at 2 to 8 mg and 17% above 8 mg against 8%, akathisia (inner restlessness) 10% against 3%, dystonia (muscle spasms, often of the neck or eyes) 3% to 4% against 2% [label 6.1, table 8]. in adult mania, parkinsonism 25% against 9%, akathisia 9% against 3%, dystonia 5% against 1% [label 6.1, table 10]. in adolescents with schizophrenia, parkinsonism 16% to 28% against 11% [label 6.1, table 9]. the label notes that the risk of acute dystonia is higher in young men, and that a change in dose of methylphenidate taken alongside risperidone has produced dystonia and dyskinesia in post-marketing reports [label 6.1; 7.2].

tardive dyskinesia [5.4] is the potentially irreversible movement disorder that can follow long treatment; the label says whether antipsychotics differ in causing it is unknown, that chronic treatment should be reserved for chronic illness with no equally effective, less harmful alternative at the lowest dose and shortest duration that works, and that in 1,885 children in the trials 2 (0.1%) developed it, both resolving when the drug stopped [label 5.4; 8.4]. a meta-analysis of 41 studies in 11,493 people put the prevalence at 20.7% on the newer antipsychotics as a class against 30.0% on the older ones, and 7.2% in people who had never taken an older drug [carbon-2017].

• neuroleptic malignant syndrome [5.3]: a rare, potentially fatal reaction with very high temperature, rigid muscles, confusion or delirium and unstable pulse or blood pressure. the label says stop at once and treat.
• low blood pressure, fainting and falls [5.7, 5.8]: fainting in 0.2% of 2,607 adults in the schizophrenia trials; the label limits the first dose to 2 mg in adults and 0.5 mg twice daily in older people and in kidney or liver disease to reduce the risk, and notes clinically significant hypotension with blood-pressure medicines. a fall-risk assessment is asked for in anyone whose other conditions or medicines add to drowsiness or unsteadiness.
• low white cells [5.9]: leukopenia and neutropenia have been reported with antipsychotics including risperidone, with frequent blood counts asked for in anyone with a low count or a history of drug-induced neutropenia.
• drowsiness [5.10]: the label makes a point most labels do not: when patients were asked with a checklist, 41% on 16 mg reported somnolence against 16% on placebo; when they were left to volunteer it, 8% against 1%. "direct questioning is more sensitive for detecting adverse events than spontaneous reporting." the label says not to drive or operate machinery until the effect is known.
• seizures [5.11]: 0.3% of 2,607 adults in the schizophrenia trials, two of them with low sodium.
• swallowing [5.12], priapism [5.13], temperature [5.14]: aspiration pneumonia is a class caution; prolonged painful erection has been reported since marketing and can need surgery; both overheating and hypothermia have been reported.
• interactions [2.5, 7.1, table 18]: carbamazepine roughly halves risperidone levels and the label says to raise the dose up to double, then lower it again if carbamazepine stops; phenytoin, rifampin and phenobarbital are expected to act the same way. fluoxetine and paroxetine raise the active level by 1.3 to 1.8 times, and the label caps the dose at 8 mg a day with either of them. cimetidine, ranitidine, erythromycin and amitriptyline need no adjustment, and risperidone does not change lithium or digoxin levels. torsade de pointes, a dangerous heart rhythm, has been reported after combined overdose of risperidone and paroxetine [10.1].
• heart rhythm [6.1]: no significant difference from placebo in qt, qtc or pr intervals in the pooled adult trials, and a mean heart-rate rise of about 1 beat per minute (4 to 6 at 8 to 16 mg). qt prolongation is nonetheless among the post-marketing reports [6.2].
• pregnancy and breastfeeding [8.1, 8.2]: babies exposed to any antipsychotic in the third trimester are at risk of movement and withdrawal symptoms after birth. the label says published studies "have not established a drug-associated risk of major birth defects", and then reports the detail: in a medicaid cohort of 9,258 women exposed to antipsychotics there was no overall increase, but in the 1,566 exposed to risperidone in the first trimester there was a small increase in major birth defects (relative risk 1.26, confidence interval 1.02 to 1.56) and a non-significant one in heart defects, with "no mechanism of action to explain the difference". risperidone passes into breast milk at 2.3% to 4.7% of the mother’s weight-adjusted dose, with reports of sedation, failure to thrive, jitteriness and tremor in breastfed infants.

what the approval trials measured, and for how long

schizophrenia in adults rests on four trials of 4 to 8 weeks in psychotic inpatients: a 6-week trial of 160 people titrated up to 10 mg, which was "marginally superior" to placebo on negative symptoms; an 8-week trial of 513 at fixed doses of 2, 6, 10 and 16 mg, in which all doses beat placebo and "the most consistently positive responses on all measures were seen for the 6 mg dose group, and there was no suggestion of increased benefit from larger doses"; an 8-week trial of 1,356 at 1 to 16 mg with no placebo arm, where 4 mg did best; and a 4-week trial of 246 at 4 and 8 mg once daily [label 14.1]. the maintenance claim rests on 365 stable outpatients randomised to risperidone or an active comparator for 1 to 2 years, with a longer time to relapse on risperidone; the label does not name the comparator [label 14.1]. two adolescent trials of 6 and 8 weeks (417 people in all) found 1 to 3 mg worked as well as 4 to 6, and "doses higher than 3 mg/day did not reveal any trend towards greater efficacy" [label 14.1; 8.4].

mania rests on two 3-week trials of 246 and 286 adults, and one 3-week trial of 169 children aged 10 to 17 in which 0.5 to 2.5 mg worked as well as 3 to 6 [label 14.2]. the add-on indication rests on one positive 3-week trial of 148 people on lithium or valproate; a second trial of 142, which also allowed carbamazepine, "was not superior", and the label attributes the failure to carbamazepine lowering risperidone levels [label 14.3]. the label is candid that for mania "there are no systematically obtained data to support the use of risperidone in such longer-term treatment (i.e., beyond 3 weeks)" [label 2.2].

the autism indication rests on two 8-week trials of 101 and 55 children aged 5 to 16, more than 90% under 12, using the irritability subscale of the aberrant behavior checklist, which covers aggression, self-injury, tantrums and rapid mood change; a third 6-week trial of 96 found a weight-based high dose worked and a dose one tenth of it did not [label 14.4]. a randomised-withdrawal extension in 39 children found fewer relapses on risperidone than placebo and was stopped early at an interim analysis of 32 completers [label 14.4]. the arithmetic that matters: the efficacy trials were 3 to 8 weeks, the one controlled long-term measurement in adults was against another antipsychotic rather than placebo, and the pediatric weight and prolactin figures above come from open-label extensions of up to a year.

side effects, with the label’s numbers

the label’s own summary of the most common reactions at 5% or more and twice placebo, across every indication: parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory infection, nasopharyngitis and sore throat [label 6]. the database behind it is 9,803 adults and children, 2,687 of them in placebo-controlled trials, with exposures up to 3 years [label 6.1].

in the 4- to 8-week adult schizophrenia trials (366 at 2 to 8 mg, 198 above 8 mg, 225 on placebo): parkinsonism 14% and 17% against 8%, akathisia 10% against 3%, sedation 10% and 5% against 2%, nausea 9% and 4% against 4%, constipation 8% and 9% against 6%, dizziness 7% and 4% against 2%, anxiety 16% and 11% against 11%, orthostatic hypotension 2% against 0% [label 6.1, table 8]. about 7% stopped for side effects against 4% [label 6.1]. in adult mania (448 against 424): parkinsonism 25% against 9%, sedation 11% against 4%, akathisia 9% against 3%, tremor 6% against 3%, dystonia 5% against 1%, nausea 5% against 2% [label 6.1, table 10].

in children the numbers run higher. adolescents with schizophrenia: sedation 24% at 1 to 3 mg against 4%, parkinsonism 16% and 28% against 11%, tremor 11% against 6%, dizziness up to 14% against 2%, salivary hypersecretion 10% at 4 to 6 mg against 2% [label 6.1, table 9]. children with mania: sedation 42% and 56% against 19%, fatigue 18% and 30% against 3%, upper abdominal pain 16% against 5%, nausea 16% against 7%, dizziness 16% against 5%, parkinsonism up to 12% against 3%; 12% stopped for side effects against 7% [label 6.1, table 12]. children with autism (107 against 115): sedation 63% against 15%, increased appetite 44% against 15%, fatigue 31% against 9%, constipation 17% against 6%, enuresis 16% against 10%, drooling 12% against 4%, tremor 8% against 1%, weight increased 8% against 2% [label 6.1, table 13]. the label notes the sedation in children was usually early and transient, with a median duration of 16 days [label 8.4].

in overdose, eight premarketing cases of 20 to 300 mg had no deaths, and post-marketing reports run to 360 mg, with drowsiness, fast heart rate, low blood pressure, movement symptoms, qt prolongation and seizures [label 10.1]. the label says risperidone "has not been systematically studied in animals or humans for its potential for abuse", and the same for tolerance or dependence [label 9.2, 9.3].

what the research says, in both directions

in favour. in a network meta-analysis of 402 randomised trials covering 53,463 adults with schizophrenia, all 32 antipsychotics reduced symptoms more than placebo and the drugs differed more in side effects than in effectiveness [huhn-2019]. in a finnish register study of 18,018 people with bipolar disorder, each compared with themselves on and off treatment, risperidone long-acting injection had the lowest risk of psychiatric rehospitalisation of any drug studied (hazard ratio 0.58), alongside lithium; the oral form was not singled out, and several authors had industry ties [lahteenvuo-2018]. in the swedish schizophrenia cohort of 29,823 people, long-acting injections as a class carried about a 22% lower rehospitalisation risk than the same drugs by mouth [tiihonen-2017]. a metabolic network meta-analysis of 18 antipsychotics placed olanzapine and clozapine at the worst end and lurasidone, aripiprazole and ziprasidone at the best; risperidone was in neither group, which matches the label’s mid-range tables [pillinger-2020].

against, or larger than it sounds. the label’s own sentence that risperidone raises prolactin more than other antipsychotics is the drug’s defining liability, and the same network meta-analysis found the prolactin range across 32 drugs ran from a fall of 77 ng/ml on clozapine to a rise of 48.5 ng/ml on paliperidone, which is risperidone’s active metabolite [huhn-2019, abstract]. the label counts gynecomastia in 2.3% of 1,885 children and says the long-term effects on growth and sexual maturation are not fully evaluated [label 8.4]. its movement side effects rise with dose from 6 mg [label 6.1, tables 16 and 17], and tardive dyskinesia remains at about one in five on the newer antipsychotics as a class [carbon-2017]. in 256 people after a first episode of psychosis in south london, continued daily use of high-potency cannabis roughly tripled the odds of relapse regardless of which antipsychotic they took, and the people who stopped did best [schoeler-2016].

how long to stay on an antipsychotic, in both directions. none of this is risperidone-specific. a finnish register study of 8,719 people after a first schizophrenia admission found the lowest risk of rehospitalisation or death in those who stayed on an antipsychotic continuously, and death 174% to 214% higher among non-users and early stoppers; people who stop are not a random sample [tiihonen-2018]. a dutch randomised trial of 128 people in remission after a first episode found, seven years on, twice the recovery rate (40.4% against 17.6%) in those assigned to guided dose reduction, with more early relapses along the way; it was small and open-label [wunderink-2013]. the label asks for the need for continued treatment to be reassessed periodically, and says for mania there is no controlled evidence beyond 3 weeks [label 5.4; 2.2].

questions people ask

what does the risperdal (risperidone) black box warning mean?

it has one part: in 17 placebo-controlled trials of antipsychotics in elderly people with dementia-related psychosis, about 4.5% died over roughly ten weeks against about 2.6% on placebo, 1.6 to 1.7 times the rate, mostly from heart or infectious causes. risperidone is not approved for that group, and its label adds that in two of four trials death was more common still when risperidone was combined with the diuretic furosemide, and that strokes were more common than on placebo. risperidone does not carry the antidepressant suicidality boxed warning because it is not approved for depression. the warning describes who should not be given the drug and who should be watched; it is not an instruction to anyone else to stop.

does risperidone cause breast growth in boys and men?

the label says risperidone raises prolactin more than other antipsychotics, that the rise persists during treatment, and that gynecomastia (male breast enlargement), milk production, missed periods and impotence have been reported with prolactin-raising drugs. its own count is in the pediatric section: across 1,885 children and adolescents in the trials, gynecomastia was reported in 2.3% and galactorrhea in 0.8%, and 49% to 87% of children had a raised prolactin level against 2% to 7% on placebo. the adult sections give no percentage. the label does not say how often it reverses, and this page does not either; the counselling section tells prescribers to advise men to seek attention for gynecomastia or erectile dysfunction. the court record on this warning is on the separate legal-record page.

how much weight do people gain on risperidone?

on the label’s numbers, adults gained a mean 0.7 kg at 1 to 8 mg and 2.2 kg above 8 mg over 3 to 8 weeks against a 0.3 kg loss on placebo, with 8.7% and 20.9% gaining 7% or more of their body weight against 2.9%; in longer studies the mean gain was 4.3 kg at 24 weeks and 5.3 kg at 48. children gained 2.0 kg against 0.6 kg in the short trials, with about a third gaining 7% or more, and 5.5 kg at 24 weeks and 8.0 kg at 48 in the extensions; adolescents with schizophrenia gained 9.0 kg over 8 months. a network meta-analysis of 18 antipsychotics placed risperidone between the lightest group (lurasidone, aripiprazole, ziprasidone) and the heaviest (olanzapine, clozapine).

what are the most common risperidone side effects?

in the adult schizophrenia trials: parkinsonism (stiffness, slowness, tremor) 14% to 17% vs 8% on placebo, akathisia (inner restlessness) 10% vs 3%, sedation up to 10% vs 2%, nausea 9% vs 4%, dizziness 7% vs 2%. in adult mania: parkinsonism 25% vs 9%, sedation 11% vs 4%, akathisia 9% vs 3%, dystonia 5% vs 1%. in children with autism: sedation 63% vs 15%, increased appetite 44% vs 15%, fatigue 31% vs 9%. movement side effects rose with dose from 6 mg. there was no qt signal in the pooled trials.

what is the maximum useful dose of risperidone?

the label says that for adults with schizophrenia "doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended"; in the fixed-dose trial the 6 mg group did best and 16 mg had twice the movement side effects. for adolescents with schizophrenia no additional benefit was seen above 3 mg, and for children with mania none above 2.5 mg. the dose is capped at 8 mg a day with fluoxetine or paroxetine, which raise risperidone levels, and may need doubling with carbamazepine, which lowers them. what dose fits a given person is a prescriber question.

is risperidone safe in pregnancy?

the label says published studies "have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes", and that untreated schizophrenia or bipolar disorder carries its own risks to the mother. it then reports a medicaid cohort of 9,258 women exposed to antipsychotics with no overall increase in major birth defects, but a small increase (relative risk 1.26) in the 1,566 exposed to risperidone in the first trimester, with no known mechanism. babies exposed to any antipsychotic in the third trimester can have movement and withdrawal symptoms after birth. a pregnancy registry exists. this is a conversation to have with a prescriber before, not after, a change.

is risperidone a controlled substance or addictive?

it is not a controlled substance. the label says risperidone "has not been systematically studied in animals or humans for its potential for abuse", nor for tolerance or physical dependence, that the trials showed no drug-seeking behaviour, and that this is not enough to predict misuse once marketed. "drug withdrawal syndrome" appears in the label’s list of reactions observed across its trials without a rate. a plan for reducing or stopping belongs with a prescriber.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

1. risperidone tablets, oral solution and orally disintegrating tablets prescribing information, fda label on dailymed (set id 701e1cd8-2868-4d29-85a9-a2212c88165f, version 35, effective august 20, 2026; janssen pharmaceuticals, nda 020588): boxed warning; sections 1, 2.1 to 2.5, 5.1 to 5.15 with tables 2 to 7, 6, 6.1 tables 8 to 17, 6.2, 7.1 table 18, 7.2, 8.1 to 8.8, 9.1 to 9.3, 10.1, 14.1 to 14.4, 17, recent major changes
2. drugs@fda, nda 020272 (risperdal), approved december 29, 1993
3. ahrq medical expenditure panel survey, prescribed medicines public-use files 2014 (hc-168a) to 2024 (hc-254a): people with at least one risperidone purchase, weighted; 2021 is the latest year meeting ahrq’s reliability rule (34 respondents in 2024, under the 60 required); computed by veisund, method on the usage section of this page
4. the antipsychotic dementia-mortality warning as a library row, written from the risperdal label: the 17-trial pooled analysis, the 2005 and 2008 fda actions, and the questions it raises (library row)
5. huhn m, et al. comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. lancet 2019 (library row written up for aripiprazole; the prolactin range is from the abstract, pubmed 31303314) (library row)
6. pillinger t, et al. comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis. lancet psychiatry 2020 (library row written up for aripiprazole; the ranking is from the abstract, pubmed 31860457) (library row)
7. lähteenvuo m, et al. real-world effectiveness of pharmacologic treatments for the prevention of rehospitalization in a finnish nationwide cohort of patients with bipolar disorder. jama psychiatry 2018 (register study; industry ties recorded on the row) (library row)
8. tiihonen j, et al. real-world effectiveness of antipsychotic treatments in a nationwide cohort of 29,823 patients with schizophrenia. jama psychiatry 2017, written up for readers; the long-acting-injection finding and the authorship cautions are on the row (library row)
9. carbon m, hsieh ch, kane jm, correll cu. tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. journal of clinical psychiatry 2017 (library row)
10. schoeler t, et al. effects of continuation, frequency, and type of cannabis use on relapse in the first 2 years after onset of psychosis: an observational study. lancet psychiatry 2016 (256 patients) (library row)
11. tiihonen j, tanskanen a, taipale h. 20-year nationwide follow-up study on discontinuation of antipsychotic treatment in first-episode schizophrenia. american journal of psychiatry 2018 (register study; the row records the selection caution) (library row)
12. wunderink l, et al. recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial. jama psychiatry 2013 (randomised, open-label, 128 people) (library row)
13. what the quetiapine (seroquel) warnings mean, the companion explainer on this site, which explains the antidepressant suicidality boxed warning that risperidone does not carry
14. the risperidone legal and safety record, a separate page on this site: court and regulator records, kept apart from the label and trial facts here

Akathisia on the risperidone label

The risperidone FDA label names akathisia in its Adverse Reactions section, in the list below.

Most-reported reactions

• Gynaecomastia10,051
• Off label use6,221
• Drug ineffective5,743
• Weight increased4,867
• Drug interaction3,313
• Abnormal weight gain3,122
• Product use in unapproved indication3,040
• Emotional disorder3,006
• Condition aggravated2,565
• Somnolence2,421