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Two medicines, side by side

Risperidone vs haloperidol

Risperidone and haloperidol are both labeled for schizophrenia. Drugs@FDA records approvals of risperidone since 1993 and of haloperidol since 1967. Pharmacies paid $0.0368 per risperidone 0.25 mg tablet and $15.60 per mL (Haloperidol dec 100 mg/mL vial) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, risperidone is an atypical antipsychotic and haloperidol a typical antipsychotic.

Check it at the source: the risperidone FDA label on DailyMed (effective May 28, 2026); the haloperidol FDA label on DailyMed (effective April 23, 2026).

Highlights of the risperidone record

Risperidone (Risperdal) · label of May 28, 2026

Boxed warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.

Used for

From the label: indications

RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. […]

On the market

Earliest approval on file
December 29, 1993
Generic labelers
37 labelers
Pharmacy cost
$0.0368 per tablet

Supply and safety

Shortage
No current entry
Recalls
5

Highlights of the haloperidol record

Haloperidol (Haldol) · label of April 23, 2026

Boxed warning

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.

Used for

From the label: indications

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). […]

On the market

Earliest approval on file
April 12, 1967
Generic labelers
41 labelers
Pharmacy cost
$15.60 per mL

Supply and safety

Shortage
A presentation being discontinued
Recalls
18

Source: FDA drug labels via openFDA (Risperidone label of May 28, 2026, Haloperidol label of April 23, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do risperidone and haloperidol differ on the record?

In FDA's classes, risperidone is an atypical antipsychotic and haloperidol a typical antipsychotic.

Both labels carry a boxed warning; the records quote them.

Generics: risperidone since 2008; haloperidol since 1986 (Drugs@FDA).

RisperidoneHaloperidol
Labeled forBipolar disorder, SchizophreniaSchizophrenia
Pharmacologic classAtypical AntipsychoticTypical Antipsychotic
How it works (label)The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism.n/a
Half-life (label)The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers.n/a
Earliest approval on file (Drugs@FDA)December 29, 1993April 12, 1967
First generic approvedJune 30, 2008June 10, 1986
Generic labelers (NDC)37 labelers41 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0368 per tablet (Risperidone 0.25 mg tablet)$15.60 per mL (Haloperidol dec 100 mg/mL vial)
12-month price change-13%no change
Boxed warningYesYes
Shortage nowNo current entryA presentation being discontinued
Recalls recorded518
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)131,09526,054
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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