Prescription medicine
Pimozide First approved as Orap
Pimozide (Orap) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $1.23 per pimozide 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pimozide FDA label on DailyMed (effective August 12, 2026, Par Health USA, LLC); the NDA 17473 record on Drugs@FDA; every pimozide label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePimozide tablets, USP are indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment.
Forms and strengths
- 1 mg
- 2 mg
Tablet.
On the market
- Earliest approval on file
- July 31, 1984 Orap, Teva; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first September 28, 2015; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.23 per tablet Pimozide 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 471 through July 30, 2026
What is pimozide used for?
From the label: indications and usagePimozide tablets, USP are indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment. Pimozide tablets, USP are not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide tablets, USP should be reserved for use in Tourette’s Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics. […]
FDA pharmacologic class: Typical Antipsychotic.
Source: FDA drug label (Pimozide), Par Health USA, LLC, effective August 12, 2026 (SPL set 70b079e2-a1f7-4a93-8685-d60a4d7c1280), via openFDA; the full label on DailyMed
Is there a generic for pimozide (Orap)?
The FDA approved the first generic pimozide on September 28, 2015. 2 generic applications are approved; 2 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 pimozide from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pimozide (Orap)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.23 per Pimozide 1 mg tablet, down 3% from $1.28 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.
- Pimozide 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pimozide 1 mg tablet | Generic | $1.23 per tablet | $37.05 | -3% |
| Pimozide 2 mg tablet | Generic | $1.64 per tablet | $49.20 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pimozide been recalled?
The FDA's Enforcement Report lists 2 recalls naming pimozide since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of pimozide and that hold 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 |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD30140_31, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pimozide label say about other medicines?
The pimozide label names 28 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name pimozide. 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 |
|---|---|---|
| Arsenic trioxide | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate … |
| Azithromycin | contraindications | For these reasons, pimozide is contraindicated in patients receiving the macrolide antibiotics clarithromycin, erythromycin, azithromycin, dirithromycin, and troleandomycin. |
| Chlorpromazine | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate … |
| Citalopram | contraindications | Concomitant use in patients taking Celexa or Lexapro is contraindicated (see PRECAUTIONS - DRUG INTERACTIONS - Pimozide and Celexa ). |
| Clarithromycin | contraindications | For these reasons, pimozide is contraindicated in patients receiving the macrolide antibiotics clarithromycin, erythromycin, azithromycin, dirithromycin, and troleandomycin. |
| Dofetilide | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate … |
| Droperidol | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate … |
| Erythromycin | contraindications | For these reasons, pimozide is contraindicated in patients receiving the macrolide antibiotics clarithromycin, erythromycin, azithromycin, dirithromycin, and troleandomycin. |
| Escitalopram | contraindications | Concomitant use in patients taking Celexa or Lexapro is contraindicated (see PRECAUTIONS - DRUG INTERACTIONS - Pimozide and Celexa ). |
| Fluoxetine | drug interactions | Rare case reports have suggested possible additive effects of pimozide and fluoxetine leading to bradycardia. |
| Fluvoxamine | contraindications | Other drugs that are relatively less potent inhibitors of CYP 3A4 should also be avoided, in view of the risks: e.g., zileuton, fluvoxamine. |
| Gatifloxacin | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate … |
| Itraconazole | contraindications | Because azole antifungal agents are also inhibitors of the CYP 3A4 enzymes and thus may likewise impair pimozide metabolism, pimozide is contraindicated in patients receiving the azole antifungal agents itraconazole and ketoconazole. |
| Ketoconazole | contraindications | Because azole antifungal agents are also inhibitors of the CYP 3A4 enzymes and thus may likewise impair pimozide metabolism, pimozide is contraindicated in patients receiving the azole antifungal agents itraconazole and ketoconazole. |
Every other medicine the pimozide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mefloquine | drug interactions | … droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, ziprasidone, or other … |
| Methylphenidate | contraindications | Pimozide should not be used in patients taking drugs that may, themselves, cause motor and phonic tics (e.g., pemoline, methylphenidate and amphetamines) until such patients have been withdrawn from … |
| Moxifloxacin | drug interactions | … thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol … |
| Nefazodone | contraindications | … indinavir, and nelfinavir. (See PRECAUTIONS - DRUG INTERACTIONS. ) Nefazodone is a potent inhibitor of CYP 3A4, and its concomitant use with pimozide is also contraindicated. |
| Nelfinavir | contraindications | … protease inhibitors such as ritonavir, saquinovir, indinavir, and nelfinavir. (See PRECAUTIONS - DRUG INTERACTIONS. ) Nefazodone is a potent inhibitor of CYP 3A4, and its concomitant use with … |
| Paroxetine | contraindications | Concomitant use of pimozide with paroxetine and other strong CYP 2D6 inhibitors is contraindicated (See PRECAUTIONS – DRUG INTERACTIONS ). |
| Quinidine | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin … |
| Ritonavir | contraindications | … contraindicated in patients receiving protease inhibitors such as ritonavir, saquinovir, indinavir, and nelfinavir. (See PRECAUTIONS - DRUG INTERACTIONS. … |
| Sertraline | contraindications | Concomitant use of pimozide in patients taking sertraline is contraindicated (See PRECAUTIONS – DRUG INTERACTIONS ). |
| Sotalol | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin … |
| Tacrolimus | drug interactions | … arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, ziprasidone, or other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects. |
| Thioridazine | drug interactions | Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin … |
| Zileuton | contraindications | Other drugs that are relatively less potent inhibitors of CYP 3A4 should also be avoided, in view of the risks: e.g., zileuton, fluvoxamine. |
| Ziprasidone | drug interactions | … trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, ziprasidone, or other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects. |
Other labels that name pimozide
Source: FDA drug label (Pimozide), Par Health USA, LLC, effective August 12, 2026 (SPL set 70b079e2-a1f7-4a93-8685-d60a4d7c1280), via openFDA; the full label on DailyMed
What do FAERS reports show for pimozide?
The FDA Adverse Event Reporting System holds 471 reports that list pimozide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 79 are coded as a death and 175 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other typical antipsychotics
- the pharmacologic class, with prices and generics
- Pimozide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other