FDA-filed SPL labeling · retrieved through openFDA

Pimozide

Pimozide is an antipsychotic tablet used to treat motor and phonic tics in people with Tourette's Disorder who have not responded to other treatments.

Brand name Orap
Drug class ⓘ Typical 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 effectiveJul 10, 2026
Clinical labels in scope ⓘ2
AvailabilityRx
Earliest approval/marketing year ⓘ1984
FDA-listed product records ⓘ12
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Pimozide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Pimozide is a last-resort option for people with Tourette's Disorder whose tics are severe and haven't responded to other treatments — it is not used for mild tics. It carries real risks, including serious heart rhythm changes and a risk of permanent involuntary movements (tardive dyskinesia), so regular monitoring and close communication with your prescriber are essential. Never start, stop, or change the dose on your own.

📖 Pimozide: Patient Information Guide

A plain-language walkthrough of Pimozide — 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▾

Pimozide is an oral antipsychotic tablet approved for one specific use:

  • Suppression of motor tics (involuntary movements) and phonic tics (involuntary sounds) in patients with Tourette's Disorder who have not responded adequately to standard treatments
  • It is only appropriate when tics are severely disrupting the patient's daily life or development — not for tics that are mild or mainly a cosmetic concern
  • Clinical evidence supporting its use was gathered in patients aged 8 to 53 years, with most participants aged 12 and older
  • Pimozide is not a first-choice treatment and is not indicated for tics caused by other conditions or medications
⚙️How it works▾

Pimozide blocks dopamine receptors — docking sites for a brain chemical involved in movement control — in the central nervous system. By blocking these receptors, it is thought to reduce the abnormal signals that trigger involuntary tics. Beyond dopamine, it also acts on other receptor systems in the brain, and these additional effects may contribute to both its benefits and its side effects.

The drug is processed primarily by liver enzymes, especially CYP 3A4, and to a lesser extent CYP 1A2 and CYP 2D6. Genetic differences in CYP 2D6 activity — present in roughly 5–10% of people — can significantly affect how much pimozide builds up in the body, which is why genetic testing may be recommended at certain doses.

💊How it's taken▾

Pimozide tablets are taken by mouth. The dose is always started low and increased gradually — finding the right dose is a careful balancing act between tic control and side effects. Children are typically directed to take their dose once at bedtime. Adults usually take it in divided doses throughout the day.

  • Never stop pimozide abruptly — a gradual taper is always recommended
  • ECG monitoring is required before starting and periodically during treatment, especially during dose changes
  • Avoid grapefruit juice, which can interfere with how the drug is broken down
  • Follow your prescriber's instructions exactly; do not adjust your dose on your own
🤒Side effects — in detail▾

Some side effects are common, especially when starting or increasing the dose:

  • Sedation and drowsiness (very common)
  • Muscle stiffness, rigidity, or Parkinson-like symptoms
  • Restlessness or an urge to keep moving (akathisia)
  • Dry mouth and constipation
  • Blurred vision or difficulty focusing
  • Behavioral changes
  • Impotence
  • Muscle tightness or stooped posture

Serious reactions — including uncontrolled face or limb movements (tardive dyskinesia), high fever with muscle rigidity (neuroleptic malignant syndrome), and heart rhythm changes — require immediate medical attention. Contact your doctor or go to the emergency room right away if any of these occur.

⚠️Warnings & precautions▾
  • Tardive dyskinesia: Long-term use can cause potentially permanent, uncontrolled movements — especially of the face, mouth, and tongue. Elderly women appear to be at highest risk. There is no reliable treatment once it develops.
  • Neuroleptic malignant syndrome (NMS): A rare but potentially fatal reaction involving high fever, severe muscle rigidity, confusion, and unstable heart rate or blood pressure. Stop pimozide and seek emergency care immediately if these signs appear.
  • Heart rhythm changes (QT prolongation): Pimozide slows the heart's electrical recovery between beats. This can lead to dangerous arrhythmias. An ECG is required before starting and during treatment. Many common drugs are prohibited because they add to this risk.
  • Sudden death risk: Unexpected deaths have occurred in studies at high doses, likely related to heart rhythm problems. Doses above the recommended limit are not advised.
  • Possible tumor risk: Animal studies showed a dose-related increase in pituitary tumors with pimozide. The significance in humans is unclear, but this is especially relevant for young patients on long-term therapy.
🔀What it interacts with▾

Pimozide has many serious drug interactions, largely because it affects heart rhythm and is processed by specific liver enzymes. Key interactions include:

  • QT-prolonging drugs (certain antiarrhythmics, antipsychotics, antibiotics, antimalarials) — combining these with pimozide greatly increases the risk of dangerous heart rhythms
  • Macrolide antibiotics (clarithromycin, erythromycin, azithromycin, and others) — contraindicated; two deaths have been reported with clarithromycin and pimozide together
  • Azole antifungals (itraconazole, ketoconazole) — block the enzyme that clears pimozide, raising drug levels dangerously
  • HIV protease inhibitors (ritonavir, saquinavir, indinavir, nelfinavir) — also block pimozide's breakdown; contraindicated
  • Antidepressants (citalopram/Celexa, escitalopram/Lexapro, paroxetine, sertraline, nefazodone, fluvoxamine) — contraindicated or to be avoided due to heart rhythm and enzyme interaction risks
  • CNS depressants (alcohol, sedatives, anti-anxiety drugs, pain relievers) — can intensify sedation
  • Stimulants (methylphenidate, amphetamines, pemoline) — these drugs can cause tics themselves; must be stopped and evaluated before starting pimozide
  • Grapefruit juice — inhibits the enzyme that breaks down pimozide; avoid completely

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▾
  • Tell your prescriber if you have a history of heart arrhythmias, congenital long QT syndrome, or low potassium or magnesium levels — pimozide is contraindicated in these cases
  • Share a full list of all medications (prescription, over-the-counter, and herbal) — many common drugs are dangerously incompatible with pimozide
  • Inform your prescriber about any prior allergic reactions to antipsychotic medications
  • Genetic testing for CYP 2D6 enzyme activity may be recommended at certain doses; people who are poor CYP 2D6 metabolizers need different dose limits
  • Older adults, especially older women, face a higher risk of tardive dyskinesia
  • Consider carefully with your prescriber before using in young patients, given the potential for long-term use and the animal findings on pituitary tumors
  • If a stimulant medication is currently being taken, it must be stopped first to determine whether the stimulant — not Tourette's — is causing the tics
  • Do not take pimozide if you are in a comatose state or have severe central nervous system depression
🚑If you take too much▾

Taking too much pimozide can cause serious heart rhythm abnormalities, severe muscle reaction problems, low blood pressure, and loss of consciousness with slowed breathing. If an overdose is suspected, emergency care is needed right away — call 911 or a poison control center immediately. Because pimozide stays in the body for a long time (the half-life is roughly 55 hours), anyone who has taken too much should be monitored for at least 4 days.

📡Pharmacodynamics — effects in the body▾

Pimozide's primary measurable effect is blocking dopamine receptors in the brain, which reduces the abnormal nerve signals believed to cause motor and phonic tics. It also prolongs the QT interval on an electrocardiogram — a measurable change in the heart's electrical pattern that can increase the risk of serious arrhythmias. At higher doses, it has been linked to electrocardiographic changes including T-wave flattening and inversion, and the appearance of U waves.

🔬Pharmacokinetics — how your body processes it▾

After taking pimozide by mouth, more than half the dose is absorbed, though the drug undergoes significant first-pass metabolism in the liver before reaching general circulation. Blood levels typically peak 6 to 8 hours after a dose (range: 4 to 12 hours). It is broken down mainly by the CYP 3A4 enzyme system, with smaller contributions from CYP 1A2 and CYP 2D6. The drug and its breakdown products are eliminated primarily through the kidneys. The average half-life — the time for the body to clear half the drug — is approximately 55 hours, meaning it stays active in the body for a long time. There is a large variation in drug levels between individuals, which is why careful dose adjustment is so important.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Dispense in a tight, light-resistant container as defined in the official compendium with a child-resistant closure as required.

📄 Written from Pimozide’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 →

180

Supplements & herbs that interact with Pimozide

180 supplements and herbal products have documented interactions with Pimozide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 12
  • Moderate · 127
  • Minor · 41
Every supplement checked against Pimozide — ranked by severity The full interaction hub: 12 major · 127 moderate · 41 minor · every one linked to its full report. Check Pimozide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

Why is my doctor prescribing pimozide instead of something else for my tics? ▾
Pimozide is reserved for Tourette's Disorder specifically when other treatments haven't worked well enough. If your doctor is recommending it, it means your tics are significantly affecting your daily life and simpler options weren't effective. It's not a first choice — it's a targeted option for a specific situation.
What side effects should I expect when I first start taking it? ▾
Sedation and drowsiness are very common, especially early on. You might also notice some muscle stiffness, restlessness, or dry mouth. Most of these tend to be milder at lower doses and your doctor will start you low and go slow. Let your prescriber know about any side effects — many can be managed by adjusting the dose.
What side effects should make me call my doctor or go to the ER right away? ▾
Two reactions need immediate attention. First, if you develop a high fever along with rigid muscles and confusion — that could be neuroleptic malignant syndrome (NMS), which is a medical emergency. Second, if you notice repetitive uncontrolled movements of your face, tongue, or limbs — that's a sign of tardive dyskinesia, which your doctor needs to know about right away. Also call if you feel heart palpitations, faint, or have a seizure.
Are there any medicines or foods I need to avoid while taking pimozide? ▾
Yes — this is really important. Pimozide has serious interactions with many common medications, including certain antibiotics (like clarithromycin and erythromycin), antifungals, HIV medications, and several antidepressants. Even grapefruit juice can be a problem because it affects how your body processes the drug. Before starting or adding any new medication — even over-the-counter — check with your pharmacist or prescriber first.
Why do I need an ECG (heart test) before and during treatment? ▾
Pimozide affects the heart's electrical system in a way that can increase the risk of a dangerous irregular heartbeat. The ECG lets your doctor check your heart rhythm before you start and makes sure it stays safe as your dose is adjusted. It's a standard precaution with this drug, not a sign that something is wrong.
Can I just stop taking pimozide if I decide I don't want to take it anymore? ▾
Please don't stop abruptly without talking to your doctor first. Stopping suddenly can cause a temporary increase in tics that might look like your condition is getting worse, but it's often just a withdrawal effect that passes. Your doctor will guide you through a gradual taper to reduce the dose safely over time.
Is Pimozide available over the counter? ▾
Pimozide 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 Pimozide first available? ▾
Pimozide has been available in the United States since at least 1984, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Pimozide? ▾
Pimozide is supplied by 6 manufacturers listed in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., Endo USA, Inc., Par Health USA, LLC.

💬 Answers drafted from Pimozide’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

💊 How Pimozide comes

Pimozide 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
How this form is used
What it may be used for
  • Pimozide tablets are used to suppress motor and phonic tics in Tourette's Disorder when other treatments have not worked
  • Pimozide tablets are reserved for patients whose tics severely affect their daily life or development
  • Pimozide tablets are not intended for simple tics or tics that are only mildly bothersome
Important instructions
  • Pimozide tablets are taken by mouth; the dose is started low and raised slowly under prescriber guidance
  • Pimozide tablets should not be stopped suddenly — your prescriber will guide a gradual taper
  • Avoid grapefruit juice while taking Pimozide tablets, as it can raise drug levels in your blood
  • An ECG (heart tracing) is required before starting Pimozide tablets and periodically during treatment
Available strengths 2 strengths
10 FDA-listed product records ⓘ

📊 Pimozide across the U.S. market

How Pimozide 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 ⓘ
6
Manufacturers
1
Brand names
12
FDA-listed product records ⓘ
1984
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

ANI Pharmaceuticals, Inc.33%
Endo USA, Inc.17%
Par Health USA, LLC17%
Par Pharmaceutical, Inc.17%
Anthem Biosciences Limited8%
Vasudha Pharma Chem Limited8%

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

📈 How widely Pimozide is used

A general measure of how commonly Pimozide 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 Pimozide 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.

5,148
Medicaid prescriptions filled (Q1–Q4 2025)
$589,952 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pimozide prescribed? Of the 1,597 medications we measure, Pimozide ranks #1,040 by Medicaid prescriptions — more than 35% of them.

Where Pimozide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Pimozide 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 2 mg oral tablet is the most-dispensed Pimozide product — about 56% of these Medicaid prescriptions.

pimozide 2 MG Oral Tablet Most dispensed

2,864 Medicaid prescriptions (Q1–Q4 2025) 56% of Pimozide prescriptions shown $378,146 gross reimbursement (before rebates) ≈ $132 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198103

pimozide 1 MG Oral Tablet

2,284 Medicaid prescriptions (Q1–Q4 2025) 44% of Pimozide prescriptions shown $211,806 gross reimbursement (before rebates) ≈ $93 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312439

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 Pimozide, 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 2 of 4 listed Pimozide NDCs with Medicaid activity.

🔍 Compare Pimozide products

A representative set of FDA-listed product records for Pimozide — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
1 mg Oral ANI Pharmaceuticals, Inc. × 2 listings ANDA View NDC →
2 mg Oral ANI Pharmaceuticals, Inc. × 2 listings ANDA View NDC →
1 mg Oral Endo USA, Inc. ANDA View NDC →
2 mg Oral Endo USA, Inc. ANDA View NDC →
1 mg Oral Par Health USA, LLC ANDA View NDC →
2 mg Oral Par Health USA, LLC ANDA View NDC →
1 mg Oral Par Pharmaceutical, Inc. ANDA View NDC →
2 mg Oral Par Pharmaceutical, Inc. ANDA View NDC →
💊Bulk drug substance
1 g/g — Anthem Biosciences Limited BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING View NDC →
1 kg/kg — Vasudha Pharma Chem Limited BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Pimozide 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) Pimozide RxCUI 8331 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 373456 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 312439 2 MG RxCUI 198103 4 MG RxCUI 104748

Look up RxCUI 8331 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

Orap

🏭 Manufacturers & labelers

ANI Pharmaceuticals, Inc. 4 Endo USA, Inc. 2 Par Health USA, LLC 2 Par Pharmaceutical, Inc. 2 Anthem Biosciences Limited 1 Vasudha Pharma Chem Limited 1

RxNorm drug class

Pimozide belongs to the Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Diphenylbutylpiperidine derivatives

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 Jul 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pimozide.
📈
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 Pimozide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
12
Distinct labelers/manufacturers represented
6
Linked representative label ⓘ
ANI Pharmaceuticals, Inc.
Linked label effective
Jul 10, 2026
Composite sections available
14
Linked SPL Set ID
4e954fc2-fdff-486c-beb6-2b8ace717081
Linked SPL Document ID
e4238455-9da3-4d89-a9ac-254292b9bf15
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. ANI 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.