Prescription medicine
Loxapine Brand names: Adasuve; first approved as Loxitane
Loxapine (Loxitane) is a prescription medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.468 per loxapine 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the loxapine FDA label on DailyMed (effective February 26, 2025, Elite Laboratories, Inc.); the NDA 17525 record on Drugs@FDA; every loxapine label on DailyMed.
Highlights of the record
FDA label of February 26, 2025; 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 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. Loxapine is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageLoxapine capsules are indicated for the treatment of schizophrenia.
Forms and strengths
- 5 mg
- 10 mg
- 25 mg
- 50 mg
Capsule; aerosol (powder).
On the market
- Earliest approval on file
- February 25, 1975 Loxitane, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first June 15, 1988; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 23, 2026 Adasuve powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.468 per capsule Loxapine 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest May 1, 2018; 1 more by firms not listed as its makers
- FAERS reports
- 3,837 through July 30, 2026
What is loxapine used for?
From the label: indications and usageLoxapine 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.
Conditions named in the indications of loxapine's FDA labels, with every medicine labeled for each:
From other loxapine labelsSchizophrenia: INDICATIONS AND USAGE Loxapine capsules are indicated for the treatment of schizophrenia.
Source: FDA drug label (Loxapine), Elite Laboratories, Inc., effective February 26, 2025 (SPL set a0cc7bb6-075f-47d1-8935-eb77a29d8c45), via openFDA; the full label on DailyMed
What does the patient leaflet for loxapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ADASUVE?ADASUVE is available only through the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program. The healthcare setting must be certified in the ADASUVE REMS Program before you can be given ADASUVE. ADASUVE may cause serious side effects, including: Narrowing of the airways (bronchospasm) that can cause you to have problems breathing or to stop breathing. People who have asthma or other airway or lung problems, such as chronic obstructive pulmonary disease (COPD), have a higher risk of bronchospasm when taking ADASUVE. Symptoms of bronchospasm may include: wheezing coughing chest tightness shortness of breath Tell your healthcare provider right away if you have any of these symptoms of bronchospasm after taking ADASUVE. Your healthcare provider should check you for breathing problems before and after you take ADASUVE. Increased risk of death in elderly patients with dementia-related psychosis. Medicines like ADASUVE can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
From the patient leaflet: What should I avoid while taking ADASUVE?Do not drive, operate heavy machinery, or do other dangerous activities until you know how ADASUVE affects you. Do not drink alcohol while taking ADASUVE. It can increase your chances of getting serious side effects.
Source: FDA drug label (Adasuve), Alexza Pharmaceuticals, Inc., effective July 6, 2026 (SPL set 50e11732-7387-452d-b3e6-db3a431d5c4a), via openFDA; the full label on DailyMed
Is there a generic for loxapine (Loxitane)?
The FDA approved the first generic loxapine on June 15, 1988. 7 generic applications are approved; 6 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 loxapine from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Loxitane capsules; a patent listed only for Adasuve powder runs to October 23, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1975 earliest approval on file
- 1988 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for loxapine (Loxitane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.468 per Loxapine 10 mg capsule, up 1% from $0.463 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.
- Loxapine 5 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Loxapine 10 mg capsule | Generic | $0.468 per capsule | $14.05 | +1% |
| Loxapine 25 mg capsule | Generic | $0.695 per capsule | $20.84 | +13% |
| Loxapine 5 mg capsule | Generic | $0.309 per capsule | $9.28 | -21% |
| Loxapine 50 mg capsule | Generic | $0.952 per capsule | $28.56 | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has loxapine been recalled?
The FDA's Enforcement Report lists 9 recalls naming loxapine since 2012: 0 Class I (the most serious), 5 Class II, 4 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of loxapine and that holds 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 |
|---|---|---|---|
| May 1, 2018 | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination |
| April 24, 2018 | Class II | Mylan Pharmaceuticals Inc. | CGMP Deviations |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204 … |
| April 17, 2012 | Class III | Watson Laboratories Inc | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the loxapine label say about other medicines?
The loxapine label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name loxapine. 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 |
|---|---|---|
| Albuterol | boxed warning | Certified healthcare settings must have a short-acting bronchodilator (e.g. albuterol) available for the immediate treatment of bronchospasm; this short-acting bronchodilator can be delivered by inhaler (with spacer) or nebulizer. |
| Amoxapine | contraindications | … bronchospasm following ADASUVE treatment [see Warnings and Precautions (5.1) ] Known hypersensitivity to loxapine or amoxapine. |
| Epinephrine | warnings and precautions | Epinephrine should not be used, because beta stimulation may worsen hypotension in the setting of ADASUVE-induced partial alpha blockade. |
| Lorazepam | drug interactions | Drug Interactions There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam. |
| Phenylephrine | warnings and precautions | In the presence of severe hypotension requiring vasopressor therapy, the preferred drugs may be norepinephrine or phenylephrine. |
Other labels that name loxapine
Source: FDA drug label (Loxapine), Elite Laboratories, Inc., effective February 26, 2025 (SPL set a0cc7bb6-075f-47d1-8935-eb77a29d8c45), via openFDA; the full label on DailyMed
What do FAERS reports show for loxapine?
The FDA Adverse Event Reporting System holds 3,837 reports that list loxapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 602 are coded as a death and 2,066 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 loxapine?
16 other medicines are given the same way (oral) and in the same FDA class as loxapine 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 |
|---|---|---|---|---|
| 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 |
| Chlorpromazine | Schizophrenia | 22 labelers | $0.552 per tablet 100 mg tablet | No current entry |
| Perphenazine | Schizophrenia | 16 labelers | $0.161 per tablet 4 mg tablet | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does loxapine compare with medicines for the same use?
3 side-by-side pages set loxapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to loxapine
- 16 medicines for the same use
- Loxapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other