Iloperidone is an atypical antipsychotic indicated for treatment of schizophrenia in adults. It is available as tablets and kits for oral use. MedsAcross supplies Iloperidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FANAPT ® is indicated for: Treatment of schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. FANAPT is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults.
Source: US FDA prescribing information
The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.
Source: US FDA prescribing information
Administer FANAPT orally twice daily without regard to meals. Titrate the dosage of FANAPT to avoid orthostatic hypotension. See Full Prescribing Information for titration schedule. Recommended Dosage: Indication Starting Dosage Recommended Dosage Schizophrenia 1 mg twice daily 6 mg to 12 mg twice daily Bipolar Mania 1 mg twice daily 12 mg twice daily CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage.
Source: US FDA prescribing information
FANAPT is contraindicated in individuals with a known hypersensitivity reaction to the product. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported. Known hypersensitivity to FANAPT or to any components in the formulation.
Source: US FDA prescribing information
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. FANAPT is not approved for the treatment of patients with dementia-related psychosis. FANAPT is not approved for use in patients with dementia-related psychosis. Cerebrovascular Adverse Reactions in Elderly Patients with Dementia- Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). QT prolongation: Prolongs QT interval and may be associated with arrhythmia and sudden death. Avoid use of FANAPT in combination with other drugs that are known to prolong QTc, use caution and consider dose modification when prescribing FANAPT with other drugs that inhibit FANAPT metabolism.
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis QT Prolongation Neuroleptic Malignant Syndrome (NMS) Tardive Dyskinesia Metabolic Changes Orthostatic Hypotension and Syncope Falls Seizures Leukopenia, Neutropenia and Agranulocytosis Hyperprolactinemia Body Temperature Regulation Dysphagia Priapism Potential for Cognitive and Motor Impairment Intraoperative Floppy Iris Syndrome Commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) were: Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
Source: US FDA prescribing information
The dose of FANAPT should be reduced in patients co-administered a strong CYP2D6 or CYP3A4 inhibitor. Clinically Important Drug Interactions with FANAPT Table 7 presents clinically important drug interactions with FANAPT. Table 7: Clinically Important Drug Interactions with FANAPT Strong CYP2D6 Inhibitors 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. Coadministration of paroxetine with iloperidone resulted in increased mean steady-state peak concentrations of iloperidone and its metabolite P88, by about 1.6- fold, and decreased mean steady-state peak concentrations of its metabolite P95 by one-half. Intervention Reduce the dose of FANAPT by one-half when administered with strong CYP2D6 inhibitors.
Source: US FDA prescribing information
Storage Store FANAPT tablets at controlled room temperature, 25℃ (77℉), excursions permitted to 15° to 30 ℃ (59° to 86℉).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
15 presentations of Iloperidone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fanapt kitOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Iloperidone 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 12 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 4 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 6 mg tabletOralGeneric name | — | US FDA | Available on request |
| Iloperidone 8 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fanapt 1 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 10 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 12 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 2 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 4 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 6 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Fanapt 8 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 6 May 2009 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Iloperidone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 15 presentations of Iloperidone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Iloperidone, including Fanapt.
Yes. The US FDA first approved Iloperidone on 6 May 2009, according to Drugs@FDA.
No listed presentation of Iloperidone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Iloperidone is classified under ATC code N05AX14 (Iloperidone).
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