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Two medicines, side by side

Haloperidol vs quetiapine

Haloperidol and quetiapine are both labeled for schizophrenia. Drugs@FDA records approvals of haloperidol since 1967 and of quetiapine since 1997. Pharmacies paid $15.60 per mL (Haloperidol dec 100 mg/mL vial) and $0.127 per quetiapine fumarate 300 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, haloperidol is a typical antipsychotic and quetiapine an atypical antipsychotic.

Check it at the source: the haloperidol FDA label on DailyMed (effective April 23, 2026); the quetiapine FDA label on DailyMed (effective April 10, 2026).

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

Highlights of the quetiapine record

Quetiapine (Seroquel) · label of April 10, 2026

Boxed warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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 [see Warnings and Precautions (5.1) ]. SEROQUEL is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ].

Used for

From the label: indications

SEROQUEL is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes (1.2) • Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). […]

On the market

Earliest approval on file
September 26, 1997
Generic labelers
48 labelers
Pharmacy cost
$0.127 per tablet

Supply and safety

Shortage
No current entry
Recalls
10

Source: FDA drug labels via openFDA (Haloperidol label of April 23, 2026, Quetiapine label of April 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do haloperidol and quetiapine differ on the record?

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

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

Generics: haloperidol since 1986; quetiapine since 2012 (Drugs@FDA).

HaloperidolQuetiapine
Labeled forSchizophreniaSchizophrenia, Bipolar disorder, Depression
Pharmacologic classTypical AntipsychoticAtypical Antipsychotic
How it works (label)n/aThe mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.
Half-life (label)n/aElimination of quetiapine is mainly via hepatic metabolism with a mean terminal half-life of about 6 hours within the proposed clinical dose range.
Earliest approval on file (Drugs@FDA)April 12, 1967September 26, 1997
First generic approvedJune 10, 1986March 27, 2012
Generic labelers (NDC)41 labelers48 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$15.60 per mL (Haloperidol dec 100 mg/mL vial)$0.127 per tablet (Quetiapine fumarate 300 mg tablet)
12-month price changeno change-9%
Boxed warningYesYes
Shortage nowA presentation being discontinuedNo current entry
Recalls recorded1810
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)26,054191,480
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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