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Two medicines, side by side

Clozapine vs loxapine

Clozapine and loxapine are both labeled for schizophrenia. Drugs@FDA records approvals of clozapine since 1989 and of loxapine since 1975. Pharmacies paid $0.610 per clozapine 100 mg tablet and $0.468 per loxapine 10 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the clozapine FDA label on DailyMed (effective June 6, 2025); the loxapine FDA label on DailyMed (effective February 26, 2025).

Highlights of the clozapine record

Clozapine (Clozaril) · label of June 6, 2025

Boxed warning

SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia CLOZARIL has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating CLOZARIL treatment, obtain baseline ANC(s).

Used for

From the label: indications

CLOZARIL is an atypical antipsychotic indicated for: • Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. […]

On the market

Earliest approval on file
September 26, 1989
Generic labelers
11 labelers
Pharmacy cost
$0.610 per tablet

Supply and safety

Shortage
No current entry
Recalls
4

Highlights of the loxapine record

Loxapine (Loxitane) · label of February 26, 2025

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

Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.

On the market

Earliest approval on file
February 25, 1975
Generic labelers
7 labelers
Pharmacy cost
$0.468 per capsule

Supply and safety

Shortage
No current entry
Recalls
8

Source: FDA drug labels via openFDA (Clozapine label of June 6, 2025, Loxapine label of February 26, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do clozapine and loxapine differ on the record?

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

Generics: clozapine since 1996; loxapine since 1988 (Drugs@FDA).

ClozapineLoxapine
Labeled forSchizophreniaSchizophrenia
Pharmacologic classAtypical Antipsychoticn/a
How it works (label)The mechanism of action of clozapine is unknown.n/a
Half-life (label)The mean elimination half-life of clozapine after a single 75 mg dose was 8 hours (range: 4 to 12 hours), compared to a mean elimination half-life of 12 hours (range: 4 to 66 hours), after achieving steady state with …n/a
Earliest approval on file (Drugs@FDA)September 26, 1989February 25, 1975
First generic approvedAugust 30, 1996June 15, 1988
Generic labelers (NDC)11 labelers7 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.610 per tablet (Clozapine 100 mg tablet)$0.468 per capsule (Loxapine 10 mg capsule)
12-month price change+5%+1%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded48
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)124,8293,837
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 do the labels say about using others of their kind?

Clozapine label, warnings and precautions

When possible, avoid use with other anticholinergic drugs and use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions.

Loxapine label, warnings

Therefore, ambulatory patients should be warned about activities requiring alertness (e.g., operating vehicles or machinery) and about concomitant use of alcohol and other CNS depressants.

Source: FDA drug labels via openFDA

What next?

Alternatives to clozapine
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