FDA-filed SPL labeling · retrieved through openFDA

Iloperidone

Iloperidone is an atypical antipsychotic used to treat schizophrenia in adults, and Fanapt is also approved for acute manic or mixed episodes associated with bipolar I disorder in adults.

Brand name Fanapt
Drug class ⓘ Atypical Antipsychotic
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 6, 2026
Clinical labels in scope ⓘ2
AvailabilityRx
Earliest approval/marketing year ⓘ2009
FDA-listed product records ⓘ62
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Iloperidone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Iloperidone is an atypical antipsychotic that treats schizophrenia in adults, and Fanapt is additionally approved for acute manic or mixed episodes in bipolar I disorder. It requires careful dose titration at the start to minimize dizziness and blood pressure drops, and its effects on heart rhythm mean it must be used cautiously alongside many other medications. Work closely with your prescriber and pharmacist to manage monitoring, dosing adjustments, and any drug interactions.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Iloperidone must NOT be used to treat psychosis related to dementia in elderly patients. Older adults with dementia who are treated with antipsychotic medications — including iloperidone — have a significantly higher risk of death compared to those taking a placebo. In clinical studies, the death rate in drug-treated patients was roughly 4.5%, compared to about 2.6% with placebo. Deaths were most often due to cardiovascular causes (such as heart failure or sudden death) or infections such as pneumonia. This risk applies to all antipsychotics in this class. Iloperidone is approved only for schizophrenia (and, for Fanapt, bipolar I mania) in adults — it is not approved for dementia-related psychosis under any circumstances.

Read the full warning on DailyMed →

📖 Iloperidone: Patient Information Guide

A plain-language walkthrough of Iloperidone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Iloperidone is an atypical antipsychotic approved for the following uses in adults:

  • Schizophrenia — both iloperidone tablets (generic) and Fanapt are approved to treat schizophrenia in adults.
  • Acute manic or mixed episodes associated with bipolar I disorder — this use is specific to Fanapt (the brand-name oral tablet) and is not an approved use of the generic iloperidone tablet.
⚙️How it works▾

Iloperidone works by blocking dopamine D2 and serotonin 5-HT2A receptors in the brain. Dopamine and serotonin are chemical messengers that influence thinking, mood, and perception. By reducing their signaling at these specific receptors, iloperidone helps ease the hallucinations, disorganized thinking, and mood instability associated with schizophrenia and bipolar mania. It also blocks norepinephrine receptors, which contributes to some of its effects — and its side effects, such as blood pressure changes.

Iloperidone is broken down by the liver into two main active byproducts (P88 and P95). Some people naturally process the drug more slowly based on their genetics (called CYP2D6 poor metabolizers), which means the drug builds up more in their system — and their dose needs to be adjusted accordingly.

💊How it's taken▾

Iloperidone tablets are taken twice daily by mouth, and can be taken with or without food. Because it can cause a significant drop in blood pressure — especially when first starting — the dose must be increased gradually over about one week following a specific titration schedule provided by your prescriber. If you stop taking iloperidone for more than 3 days for any reason, that gradual titration needs to be restarted from the beginning.

  • Can be taken with or without food — food does not meaningfully change how much of the drug is absorbed.
  • People who are CYP2D6 poor metabolizers (a genetic variation affecting drug processing) or who take certain interacting medications may need a lower dose.
  • People with severe liver impairment should not use iloperidone; those with moderate liver impairment may need a dose reduction.
🤒Side effects — in detail▾

The most commonly reported side effects — those occurring in at least 5% of patients and at least twice as often as with placebo — include:

  • Dizziness (especially when standing up)
  • Drowsiness or somnolence
  • Dry mouth
  • Fast heartbeat (tachycardia)
  • Nasal congestion
  • Weight gain
  • Fatigue
  • Low blood pressure when standing (orthostatic hypotension)

Serious reactions that require immediate medical attention include signs of heart rhythm problems (palpitations, fainting), high fever with muscle rigidity (which could indicate Neuroleptic Malignant Syndrome), and uncontrolled repetitive movements (tardive dyskinesia). A painful prolonged erection (priapism) is a rare but urgent emergency — seek care immediately.

⚠️Warnings & precautions▾
  • QT prolongation and heart rhythm risk: Iloperidone lengthens the QT interval in the heart. This can rarely trigger a dangerous arrhythmia. The risk increases with other QT-prolonging drugs, low potassium or magnesium, and in people who process the drug slowly. Avoid combining it with drugs known to prolong QT, and tell your doctor about all medications you take.
  • Neuroleptic Malignant Syndrome (NMS): A rare but potentially fatal reaction involving high fever, severe muscle rigidity, altered consciousness, and unstable blood pressure or heart rate. Stop the medication immediately and seek emergency care if these symptoms occur.
  • Tardive dyskinesia: Long-term use can cause potentially irreversible, involuntary muscle movements, particularly in older adults. Use the lowest effective dose for the shortest necessary time.
  • Metabolic changes: Can raise blood sugar, increase blood fats, and cause significant weight gain — all of which can raise cardiovascular risk over time. Blood sugar should be monitored.
  • Orthostatic hypotension: A sudden drop in blood pressure when standing can cause dizziness or fainting, especially early in treatment. Dose titration helps reduce this risk.
  • Elderly patients with dementia-related psychosis: Iloperidone is NOT approved for this use and carries a significantly increased risk of death in this group.
  • Low white blood cell count: Iloperidone can reduce infection-fighting white blood cells. Patients with a history of low white counts need monitoring.
🔀What it interacts with▾

Iloperidone interacts with several important drug categories — always tell your pharmacist and prescriber everything you take:

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) — these slow how your body breaks down iloperidone, raising its blood levels significantly; your dose should be cut in half while taking them.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) — similarly raise iloperidone levels; dose reduction by half is required.
  • Other QT-prolonging drugs (e.g., certain antiarrhythmics such as quinidine, amiodarone, or sotalol; some antibiotics such as moxifloxacin or gatifloxacin; other antipsychotics such as thioridazine or chlorpromazine; methadone) — combining these with iloperidone increases the risk of a dangerous heart rhythm and should be avoided.
  • Blood-pressure-lowering medications and alpha-blockers — can intensify iloperidone's blood-pressure-lowering effect, potentially causing dangerous hypotension; avoid or adjust carefully.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy: Do not take iloperidone if you have had a hypersensitivity reaction (such as anaphylaxis or severe swelling) to it or any of its ingredients.
  • Heart conditions: Use with caution — and discuss with your doctor — if you have a history of QT prolongation, cardiac arrhythmias, recent heart attack, or uncompensated heart failure.
  • Liver problems: No dose adjustment is needed for mild liver impairment. Moderate liver impairment may require a lower dose. Severe liver impairment: iloperidone is not recommended.
  • Genetics / slow drug metabolizers: If you are a CYP2D6 poor metabolizer, you will need a lower dose — your doctor may order genetic testing.
  • Seizure history: Use cautiously; iloperidone can lower the seizure threshold.
  • Pregnancy: Babies born to mothers who took antipsychotics in the third trimester can experience withdrawal symptoms or movement problems after delivery. A pregnancy registry exists — ask your doctor about it.
  • Breastfeeding: Do not breastfeed while taking iloperidone; it may pass into breast milk and could harm a nursing infant.
  • Children and adolescents: Safety and effectiveness have not been established in patients under 18.
  • Older adults with dementia: Iloperidone must NOT be used for dementia-related psychosis — the risk of death is significantly elevated in this population.
  • Cataract surgery: Tell your eye surgeon you take iloperidone — it can cause Intraoperative Floppy Iris Syndrome (IFIS), which requires changes to surgical technique.
🚑If you take too much▾

Taking too much iloperidone can cause drowsiness, sedation, fast heartbeat, and low blood pressure. At very high amounts, it can also affect the heart's rhythm (QT prolongation) and cause extrapyramidal symptoms (muscle stiffness or spasms). There is no specific antidote.

If an overdose is suspected, call Poison Control at 1-800-222-1222 or go to the nearest emergency room immediately. Medical staff will focus on monitoring heart rhythm continuously and providing supportive care — do not induce vomiting, as iloperidone can affect swallowing reflexes.

📡Pharmacodynamics — effects in the body▾

Iloperidone blocks several receptor types in the brain and body. It has the strongest blocking effect at serotonin 5-HT2A, dopamine D2 and D3, and norepinephrine alpha-1 (NEα1) receptors. It also has moderate activity at dopamine D4 and serotonin 5-HT6 and 5-HT7 receptors. Notably, iloperidone has very little effect on histamine H1 receptors and almost no effect on muscarinic (acetylcholine) receptors, which may explain why it causes less sedation and fewer dry-mouth-type effects than some older antipsychotics. One of its breakdown products, P95, mainly affects serotonin and norepinephrine receptors and contributes to the drug's overall activity profile.

🔬Pharmacokinetics — how your body processes it▾

After swallowing an iloperidone tablet, the drug is well absorbed and reaches peak blood levels within 2 to 4 hours. Food does not meaningfully change the total amount absorbed, so it can be taken with or without meals. Iloperidone is broken down mainly by the liver — through enzymes called CYP2D6 and CYP3A4 — into two main active metabolites (P88 and P95). Steady drug levels in the blood are generally reached within 3 to 4 days of twice-daily dosing.

How long the drug stays in the body depends on your genetics: people who process it at a normal rate (extensive metabolizers) have a half-life of about 18 hours for the parent drug, while those who process it more slowly (poor metabolizers — about 7–10% of Caucasians) have a half-life closer to 33 hours, meaning the drug lingers longer and can build up to higher levels. Most of the drug is eliminated through the urine, with a smaller portion leaving through stool.

📦How to store it▾

Store FANAPT tablets at controlled room temperature, 25℃ (77℉); excursions permitted to 15° to 30 ℃ (59° to 86℉) .

📄 Written from Iloperidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Iloperidone — the kind of thing our pharmacy team would talk through with you at the counter.

What is iloperidone actually used for? ▾
Iloperidone tablets are approved to treat schizophrenia in adults. If you've been prescribed the brand Fanapt, it has one additional approved use: treating acute manic or mixed episodes in adults with bipolar I disorder. So the specific condition it's targeting for you depends on what your doctor prescribed it for — and which product you have.
Why do I have to start on such a small dose and increase it slowly? ▾
Iloperidone can cause a significant drop in blood pressure when you first start it — especially when you stand up quickly — which can make you dizzy or even faint. That's called orthostatic hypotension. Starting low and gradually stepping up the dose over about a week gives your body time to adjust and keeps that risk manageable. If you've been off the medication for more than 3 days for any reason, you'll need to do that slow ramp-up again from the beginning.
What side effects should I expect, and which ones should make me call my doctor? ▾
The most common side effects include dizziness (especially when standing), drowsiness, dry mouth, a fast heartbeat, nasal congestion, fatigue, and some weight gain. Most of these ease as your body adjusts. But call your doctor right away — or call 911 — if you experience chest pain, fainting, palpitations, or a very fast or irregular heartbeat, as these could signal a heart rhythm problem. Also contact your doctor immediately if you develop a high fever with severe muscle stiffness or confusion, or if you notice uncontrolled, repetitive movements in your face, tongue, or limbs.
Are there medications I need to avoid while taking iloperidone? ▾
Yes — this is important. Several drugs can raise iloperidone's levels in your blood or add to its effects on your heart. Antidepressants like fluoxetine (Prozac) and paroxetine (Paxil), and antifungals like ketoconazole, can raise iloperidone levels enough that your dose needs to be cut in half. A long list of other medications — including certain antibiotics, heart rhythm drugs, and other antipsychotics — can also affect your heart rhythm when combined with iloperidone. Always tell every prescriber and your pharmacist that you're taking iloperidone before starting anything new.
Is it safe to take iloperidone if I'm pregnant or breastfeeding? ▾
If you take iloperidone in the third trimester of pregnancy, your newborn could experience withdrawal symptoms or temporary movement problems after birth — so close monitoring of the baby is important. There's a national pregnancy registry you can join for tracking and support; ask your doctor about it. As for breastfeeding, you should not breastfeed while taking this medication, because iloperidone may pass into breast milk and could affect your baby. Talk to your doctor about the safest options for you.
I'm an older adult taking care of a parent with dementia — can iloperidone help with their behavioral symptoms? ▾
No — iloperidone must not be used for dementia-related behavioral problems or psychosis. This is a serious safety issue: antipsychotic medications, including iloperidone, have been shown to significantly increase the risk of death in elderly people with dementia. It is not approved for that use. If you're managing behavioral symptoms in a loved one with dementia, please talk to their doctor about safer, evidence-based alternatives.
Is Iloperidone available over the counter? ▾
Iloperidone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Iloperidone first available? ▾
Iloperidone has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Iloperidone? ▾
Iloperidone is supplied by 10 manufacturers listed in the FDA NDC Directory, including Vanda Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Taro Pharmaceuticals U.S.A., Inc..

💬 Answers drafted from Iloperidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerIloperidone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Iloperidone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Iloperidone comes

Iloperidone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Fanapt
How this form is used
What it may be used for
  • Iloperidone tablets are used to treat schizophrenia in adults.
  • Fanapt tablets are also approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Important instructions
  • Fanapt and iloperidone tablets are both taken by mouth twice daily, with or without food.
  • Fanapt and iloperidone tablets must be started at a low dose and increased gradually over about one week to reduce the risk of dizziness from a blood-pressure drop — follow your prescriber's titration schedule exactly.
  • Fanapt: if you've been off the medication for more than 3 days, the full titration schedule should be restarted — do not jump back to your previous dose.
  • Iloperidone tablets: if you've been off the medication for more than 3 days, the initiation titration schedule should be followed again before resuming your maintenance dose.
Available strengths 7 strengths
1 mg 2 mg 4 mg 6 mg 8 mg 10 mg
Show 1 more strength Show fewer strengths
12 mg
41 FDA-listed product records ⓘ

📊 Iloperidone across the U.S. market

How Iloperidone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
10
Manufacturers
2
Brand names
62
FDA-listed product records ⓘ
2009
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Kit (13) · Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Vanda Pharmaceuticals Inc.45%
Mylan Pharmaceuticals Inc.23%
Taro Pharmaceuticals U.S.A., Inc.13%
Patheon Inc.6%
Formosa Laboratories, Inc.3%
PROCOS SpA3%
Other makers6%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Iloperidone is used

A general measure of how commonly Iloperidone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Iloperidone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

31,677
Medicaid prescriptions filled (Q1–Q4 2025)
$63.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Iloperidone prescribed? Of the 1,596 medications we measure, Iloperidone ranks #728 by Medicaid prescriptions — more than 54% of them.

Where Iloperidone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #728 of 1,596
#723 Penicillin G Benzathin... 31,924 Rx #724 Filgrastim Injection 31,849 Rx #725 Guselkumab Injection 31,774 Rx #726 Loxapine 31,747 Rx #727 Econazole Topical 31,736 Rx #728 Iloperidone 31,677 Rx #729 Tapinarof Topical 31,509 Rx #730 Halcinonide Topical 31,482 Rx #731 Tazarotene Topical 31,374 Rx #732 Atovaquone and Proguan... 31,273 Rx #733 Meropenem Injection 31,115 Rx

Utilization by Iloperidone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 6 mg oral tablet is the most-dispensed Iloperidone product — about 22% of these Medicaid prescriptions.

iloperidone 6 MG Oral Tablet Most dispensed

6,957 Medicaid prescriptions (Q1–Q4 2025) 22% of Iloperidone prescriptions shown $13.2M gross reimbursement (before rebates) ≈ $1,901 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848744

iloperidone 12 MG Oral Tablet

5,357 Medicaid prescriptions (Q1–Q4 2025) 17% of Iloperidone prescriptions shown $16M gross reimbursement (before rebates) ≈ $2,987 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848732

iloperidone 8 MG Oral Tablet

4,890 Medicaid prescriptions (Q1–Q4 2025) 15% of Iloperidone prescriptions shown $9.6M gross reimbursement (before rebates) ≈ $1,957 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848748

iloperidone 4 MG Oral Tablet

4,238 Medicaid prescriptions (Q1–Q4 2025) 13% of Iloperidone prescriptions shown $6.1M gross reimbursement (before rebates) ≈ $1,441 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848740

iloperidone 2 MG Oral Tablet

3,969 Medicaid prescriptions (Q1–Q4 2025) 13% of Iloperidone prescriptions shown $5.7M gross reimbursement (before rebates) ≈ $1,436 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848736

iloperidone 1 MG Oral Tablet

3,485 Medicaid prescriptions (Q1–Q4 2025) 11% of Iloperidone prescriptions shown $4.9M gross reimbursement (before rebates) ≈ $1,404 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848722

iloperidone 10 MG Oral Tablet

2,652 Medicaid prescriptions (Q1–Q4 2025) 8% of Iloperidone prescriptions shown $7.8M gross reimbursement (before rebates) ≈ $2,956 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848728

Other Iloperidone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

129 Medicaid prescriptions (Q1–Q4 2025) <1% of Iloperidone prescriptions shown $29,228 gross reimbursement (before rebates) ≈ $227 per prescription (gross)

Summed across the 1 of 19 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Iloperidone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 58 listed Iloperidone NDCs with Medicaid activity.

🔍 Compare Iloperidone products

A representative set of FDA-listed product records for Iloperidone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 62 of 62 products — FDA National Drug Code Directory. See every product, package size and price: browse all 62 Iloperidone NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Iloperidone RxCUI 73178 1 dose form · 7 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 848721 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 848722 2 MG RxCUI 848736 4 MG RxCUI 848740 6 MG RxCUI 848744 8 MG RxCUI 848748 10 MG RxCUI 848728 12 MG RxCUI 848732

Look up RxCUI 73178 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Fanapt

🏭 Manufacturers & labelers

Vanda Pharmaceuticals Inc. 28 Mylan Pharmaceuticals Inc. 14 Taro Pharmaceuticals U.S.A., Inc. 8 Patheon Inc. 4 Formosa Laboratories, Inc. 2 PROCOS SpA 2 MSN Organics Private Limited 1 Sterling Pharma Solutions Limited 1 Symed Labs Limited 1 Viyash Scientific Limited 1

RxNorm drug class

Iloperidone belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 6, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Iloperidone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Iloperidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
62
Distinct labelers/manufacturers represented
10
Linked representative label ⓘ
Vanda Pharmaceuticals Inc.
Linked label effective
May 6, 2026
Composite sections available
24
Linked SPL Set ID
33f60b40-3fca-11de-8f56-0002a5d5c51b
Linked SPL Document ID
2609a5b3-d7ec-48a9-a32b-54a9b207f9aa
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Vanda Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.