Prescription medicine
Iloperidone Brand names: Fanapt
Iloperidone (Fanapt) is a prescription medicine with an FDA approval on record since 2009. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $60.01 per Fanapt 12 mg tablet.
- Generic approved
- Boxed warning
Check it at the source: the iloperidone FDA label on DailyMed (effective May 6, 2026, Vanda Pharmaceuticals Inc.); the NDA 22192 record on Drugs@FDA; every iloperidone label on DailyMed.
Highlights of the record
FDA label of May 6, 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. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis.
Used for
From the label: indications and usageFANAPT ® is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ].
Forms and strengths
- 1 mg
- 2 mg
- 4 mg
- 6 mg
- 8 mg
- 10 mg
- 12 mg
Tablet; kit.
On the market
- Earliest approval on file
- May 6, 2009 Fanapt, Vanda Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first November 28, 2016; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 28, 2031 Fanapt tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $60.01 per tablet Fanapt 12 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,470 through July 30, 2026
What is iloperidone used for?
From the label: indications and usageFANAPT ® is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ]. FANAPT is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Conditions named in the indications of iloperidone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (FANAPT), Vanda Pharmaceuticals Inc., effective May 6, 2026 (SPL set 33f60b40-3fca-11de-8f56-0002a5d5c51b), via openFDA; the full label on DailyMed
Is there a generic for iloperidone (Fanapt)?
The FDA approved the first generic iloperidone on November 28, 2016. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists iloperidone from 1 labeler 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. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 11 patents for Fanapt tablets, the last expiring on December 28, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2016 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for iloperidone (Fanapt)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $60.01 per Fanapt 12 mg tablet, up 4% from $57.84 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.
- Fanapt 1 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fanapt 1 mg tablet | Brand | $30.50 per tablet | $914.95 | +4% |
| Fanapt 10 mg tablet | Brand | $60.29 per tablet | $1,808.60 | +4% |
| Fanapt 12 mg tablet | Brand | $60.01 per tablet | $1,800.30 | +4% |
| Fanapt 2 mg tablet | Brand | $30.74 per tablet | $922.13 | +4% |
| Fanapt 4 mg tablet | Brand | $30.53 per tablet | $915.91 | +4% |
| Fanapt 6 mg tablet | Brand | $37.61 per tablet | $1,128.43 | +4% |
| Fanapt 8 mg tablet | Brand | $37.48 per tablet | $1,124.47 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the iloperidone label say about other medicines?
The iloperidone label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name iloperidone. 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 |
|---|---|---|
| Amiodarone | warnings and precautions | The use of FANAPT should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin … |
| Aripiprazole | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Chlorpromazine | warnings and precautions | The use of FANAPT should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin … |
| Fluoxetine | drug interactions | Clinical Impact; Coadministration of fluoxetine with iloperidone increased exposure (area under curve, [AUC]) of iloperidone and its metabolite P88, by about 2- to 3- fold, and decreased the AUC of its metabolite P95 by one-half [see, ]. … |
| Gatifloxacin | warnings and precautions | … antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). |
| Ketoconazole | drug interactions | Clinical Impact; Co-administration of ketoconazole with iloperidone, increased the AUC of iloperidone and its metabolites P88 and P95 by 57%, 55%, and 35%, respectively [see ]. |
| Methadone | warnings and precautions | … any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). |
| Moxifloxacin | warnings and precautions | … medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). |
| Olanzapine | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Paroxetine | drug interactions | Clinical Impact; Coadministration of fluoxetine with iloperidone increased exposure (area under curve, [AUC]) of iloperidone and its metabolite P88, by about 2- to 3- fold, and decreased the AUC of its metabolite P95 by one-half [see, ]. … |
| Procainamide | warnings and precautions | The use of FANAPT should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin … |
| Quinidine | warnings and precautions | The use of FANAPT should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin … |
| Risperidone | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Sotalol | warnings and precautions | The use of FANAPT should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin … |
Every other medicine the iloperidone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Thioridazine | warnings and precautions | … antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc … |
Other labels that name iloperidone
Source: FDA drug label (FANAPT), Vanda Pharmaceuticals Inc., effective May 6, 2026 (SPL set 33f60b40-3fca-11de-8f56-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show for iloperidone?
The FDA Adverse Event Reporting System holds 1,470 reports that list iloperidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 60 are coded as a death and 221 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 iloperidone?
21 other medicines are given the same way (oral) and in the same FDA class as iloperidone 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 | Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | 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 |
Every medicine labeled for the same conditions as iloperidone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does iloperidone compare with medicines for the same use?
3 side-by-side pages set iloperidone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to iloperidone
- 21 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Iloperidone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other