Two medicines, side by side
Clozapine vs haloperidol
Clozapine and haloperidol are both labeled for schizophrenia. Drugs@FDA records approvals of clozapine since 1989 and of haloperidol since 1967. Pharmacies paid $0.610 per clozapine 100 mg tablet and $15.60 per mL (Haloperidol dec 100 mg/mL vial) (NADAC, October 7, 2026). In FDA's classes, clozapine is an atypical antipsychotic and haloperidol a typical antipsychotic.
Check it at the source: the clozapine FDA label on DailyMed (effective June 6, 2025); the haloperidol FDA label on DailyMed (effective April 23, 2026).
Highlights of the clozapine record
Clozapine (Clozaril) · label of June 6, 2025
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: indicationsCLOZARIL 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 haloperidol record
Haloperidol (Haldol) · label of April 23, 2026
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: indicationsHaloperidol 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 (Clozapine label of June 6, 2025, Haloperidol label of April 23, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do clozapine and haloperidol differ on the record?
In FDA's classes, clozapine is an atypical antipsychotic and haloperidol a typical antipsychotic.
Both labels carry a boxed warning; the records quote them.
Generics: clozapine since 1996; haloperidol since 1986 (Drugs@FDA).
| Clozapine | Haloperidol | |
|---|---|---|
| Labeled for | Schizophrenia | Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Typical Antipsychotic |
| 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, 1989 | April 12, 1967 |
| First generic approved | August 30, 1996 | June 10, 1986 |
| Generic labelers (NDC) | 11 labelers | 41 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.610 per tablet (Clozapine 100 mg tablet) | $15.60 per mL (Haloperidol dec 100 mg/mL vial) |
| 12-month price change | +5% | no change |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 4 | 18 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 124,829 | 26,054 |
| DEA schedule | none | none |
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 precautionsWhen 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.
Source: FDA drug labels via openFDA
What next?
- Alternatives to clozapine
- every medicine labeled for the same conditions