Prescription medicine
Chlorpromazine First approved as Thorazine
Chlorpromazine (Thorazine) is a prescription medicine with an FDA approval on record since 1957. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $0.552 per chlorpromazine 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the chlorpromazine FDA label on DailyMed (effective May 12, 2026, Amneal Pharmaceuticals NY LLC); the NDA 11120 record on Drugs@FDA; every chlorpromazine label on DailyMed.
Highlights of the record
FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageFor the management of manifestations of psychotic disorders.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 100 mg
- 200 mg
- 25 mg/ml
- 30 mg/ml
- 100 mg/ml
Film-coated tablet; sugar-coated tablet; injection; tablet; coated tablet.
On the market
- Earliest approval on file
- September 18, 1957 Thorazine, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 64 first March 16, 1972; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 33 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.552 per tablet Chlorpromazine 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 25 since 2013 0 Class I among all firms' recalls; latest September 3, 2025; 3 more by firms not listed as its makers
- FAERS reports
- 7,098 through July 30, 2026
What is chlorpromazine used for?
From the label: indications and usageFor the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. […]
Conditions named in the indications of chlorpromazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Phenothiazine.
Source: FDA drug label (CHLORPROMAZINE HYDROCHLORIDE), Amneal Pharmaceuticals NY LLC, effective May 12, 2026 (SPL set aa086a21-de85-4b03-af58-49b70acf8cf0), via openFDA; the full label on DailyMed
Is there a generic for chlorpromazine (Thorazine)?
The FDA approved the first generic chlorpromazine on March 16, 1972. 64 generic applications are approved; 28 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists chlorpromazine from 33 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1957 earliest approval on file
- 1972 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for chlorpromazine (Thorazine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.552 per Chlorpromazine 100 mg tablet, down 27% from $0.754 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Chlorpromazine 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chlorpromazine 10 mg tablet | Generic | $0.242 per tablet | $7.25 | -10% |
| Chlorpromazine 100 mg tablet | Generic | $0.552 per tablet | $16.57 | -27% |
| Chlorpromazine 200 mg tablet | Generic | $0.664 per tablet | $19.91 | -48% |
| Chlorpromazine 25 mg tablet | Generic | $0.324 per tablet | $9.73 | -16% |
| Chlorpromazine 50 mg tablet | Generic | $0.414 per tablet | $12.43 | -24% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has chlorpromazine been recalled?
The FDA's Enforcement Report lists 28 recalls naming chlorpromazine since 2013: 0 Class I (the most serious), 28 Class II, 0 Class III; 26 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of chlorpromazine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 3, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit |
| August 27, 2025 | Class II | Amerisource Health Services LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of … |
| August 25, 2025 | Class II | AvKARE | Presence of a foreign substance. |
| August 18, 2025 | Class II | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. … |
| April 14, 2025 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit |
| April 3, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit |
| March 11, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. |
| December 11, 2024 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlorpromazine label say about other medicines?
The chlorpromazine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 36 other medicines name chlorpromazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | warnings | An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus an antipsychotic. |
Other labels that name chlorpromazine
- Amphetamine
- Anhydrous citric acid and magnesium oxide and sodium picosulfate
- Apomorphine
- Asenapine
- Citalopram
- Clorazepate
- Clozapine
- Desmopressin
- Dextroamphetamine
- Fingolimod
- Iloperidone
- Macimorelin
- Magnesium sulfate and potassium chloride and sodium sulfate
- Magnesium sulfate and potassium sulfate and sodium sulfate
- Magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients
- Meperidine
- Milsaperidone
- Paliperidone
- Pimavanserin
- Pimozide
- Propranolol
- Tetrabenazine
- Tranexamic acid
- Trazodone
- Valproic acid
- Ziprasidone
- Zolpidem
Source: FDA drug label (CHLORPROMAZINE HYDROCHLORIDE), Amneal Pharmaceuticals NY LLC, effective May 12, 2026 (SPL set aa086a21-de85-4b03-af58-49b70acf8cf0), via openFDA; the full label on DailyMed
What do FAERS reports show for chlorpromazine?
The FDA Adverse Event Reporting System holds 7,098 reports that list chlorpromazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,324 are coded as a death and 3,306 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as chlorpromazine?
17 other medicines are given the same way (oral) and in the same FDA class as chlorpromazine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Perphenazine | Schizophrenia, Nausea and vomiting | 16 labelers | $0.161 per tablet 4 mg tablet | No current entry |
| Prochlorperazine | Schizophrenia, Nausea and vomiting | 29 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Trifluoperazine | Schizophrenia | 6 labelers | $0.579 per tablet 2 mg tablet | No current entry |
| Quetiapine | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Haloperidol | Schizophrenia | 28 labelers | $0.181 per tablet 5 mg tablet | A presentation being discontinued |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
Every medicine labeled for the same conditions as chlorpromazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does chlorpromazine compare with medicines for the same use?
7 side-by-side pages set chlorpromazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to chlorpromazine
- 17 medicines for the same use
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Chlorpromazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other