pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cytochrome P450 2D6 Inhibitors; Dopamine Antagonists; Protease Inhibitors.

Cytochrome P450 2D6DopamineProtease

Indications

Sourced from openFDA
  • & USAGE Pimozide tablets 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 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.

Contraindications

Sourced from openFDA
  • Pimozide is contraindicated in the treatment of simple tics or tics other than those associated with Tourette’s Disorder. 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cause motor and phonic tics (e.g., pemoline, methylphenidate and amphetamines) until such patients have been withdrawn from these drugs to determine whether or not the drugs, rather than Tourette’s Disorder, are responsible for the tics.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION General The suppression of tics by pimozide tablets requires a slow and gradual introduction of the drug. The patient’s dose should be carefully adjusted to a point where the suppression of tics and the relief afforded is balanced against the untoward side effects of the drug. An ECG should be done at baseline and periodically thereafter, especially during the period of dose adjustment (see WARNINGS and PRECAUTIONS - Laboratory Tests ). Periodic attempts should be made to reduce the dosage of pimozide tablets to see whether or not tics persist at the level and extent first identified. In attempts to reduce the dosage of pimozide tablets consideration should be given to the possibility that increases of tic intensity and frequency may represent a transient, withdrawal related phenomenon rather than a return of disease symptoms. Specifically, one to two weeks should be allowed to elapse before one concludes that an increase in tic manifestations is a function of the underlying disease syndrome rather than a response to drug withdrawal. A gradual withdrawal is recommended in any case. Children Reliable dose response data for the effects of pimozide tablets on tic manifestation in Tourette’s Disorder patients below the age of twelve are not available. Treatment should be initiated at a dose of 0.05 mg/kg preferably taken once at bedtime. The dose may be increased every third day to a maximum of 0.2 mg/kg not to exceed 10 mg/day. At doses above 0.05 mg/kg/day, CYP 2D6 genotyping should be performed.

Warnings & precautions

Sourced from openFDA

The use of pimozide in the treatment of Tourette’s Disorder involves different risk/benefit considerations than when antipsychotic drugs are used to treat other conditions. Consequently, a decision to use pimozide should take into consideration the following (see also PRECAUTIONS - Information for Patients ). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process.

Adverse reactions

Sourced from openFDA

General Extrapyramidal Reactions: Neuromuscular (extrapyramidal) reactions during the administration of pimozide have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved Parkinson-like symptoms which, when first observed, were usually mild to moderately severe and usually reversible. Other types of neuromuscular reactions (motor restlessness, dystonia, akathisia, hyperreflexia, opisthotonos, oculogyric crises) have been reported far less frequently. Severe extrapyramidal reactions have been reported to occur at relatively low doses. Generally the occurrence and severity of most extrapyramidal symptoms are doserelated since they occur at relatively high doses and have been shown to disappear or become less severe when the dose is reduced. Administration of antiparkinson drugs such as benztropine mesylate or trihexyphenidyl hydrochloride may be required for control of such reactions. It should be noted that persistent extrapyramidal reactions have been reported and that the drug may have to be discontinued in such cases. Withdrawal Emergent Neurological Signs: Generally, patients receiving short term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under “Tardive Dyskinesia” except for duration.

Use in specific populations

Sourced from openFDA

PREGNANCY Teratogenic Effects: Reproduction studies performed in rats and rabbits at oral doses up to 8 times the maximum human dose did not reveal evidence of teratogenicity. In the rat, however, this multiple of the human dose resulted in decreased pregnancies and in the retarded development of fetuses. These effects are thought to be due to an inhibition or delay in implantation which is also observed in rodents administered other antipsychotic drugs. In the rabbit, maternal toxicity, mortality, decreased weight gain, and embryotoxicity including increased resorptions were dose-related. Because animal reproduction studies are not always predictive of human response, pimozide should be given to a pregnant woman only if the potential benefits of treatment clearly outweigh the potential risks. Nonteratogenic effects. Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Overdosage

Sourced from openFDA

In general, the signs and symptoms of overdosage with pimozide would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) electrocardiographic abnormalities, 2) severe extrapyramidal reactions, 3) hypotension, 4) a comatose state with respiratory depression. In the event of overdosage, gastric lavage, establishment of a patent airway and, if necessary, mechanically-assisted respiration are advised. Electrocardiographic monitoring should commence immediately and continue until the ECG parameters are within the normal range. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered. Because of the long half-life of pimozide, patients who take an overdose should be observed for at least 4 days. As with all drugs, the physician should consider contacting a poison control center for additional information on the treatment of overdose.

Approval history

Sourced from openFDA
  • Sep 28, 2015ANDAANDA204521Ph Health
  • Apr 13, 2026ANDAANDA219897Novitium Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
464 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Interaction7616%
  2. 2Drug Ineffective469.9%
  3. 3Parkinsonism429.1%
  4. 4Weight Increased378.0%
  5. 5Somnolence337.1%
  6. 6Hypotension296.3%
  7. 7Neuroleptic Malignant Syndrome296.3%
  8. 8Dystonia286.0%
  9. 9Off Label Use286.0%
  10. 10Toxicity To Various Agents265.6%
  11. 11Atrioventricular Septal Defect235.0%
  12. 12Condition Aggravated235.0%
  13. 13Electrocardiogram Qt Prolonged235.0%
  14. 14Dysmorphism224.7%
  15. 15Foetal Exposure During Pregnancy194.1%

Literature

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Recent PubMed references pinned to Pimozide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Pimozide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Pimozide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC A/B (provisional)FDA label: Testing Required

Frequently asked questions

How does Pimozide work?
Mechanism-of-action classes: Cytochrome P450 2D6 Inhibitors; Dopamine Antagonists; Protease Inhibitors.
What is Pimozide used for?
According to FDA labeling, Pimozide carries indications including: & USAGE Pimozide tablets 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 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pimozide?
Pimozide is classified as Diphenylbutylpiperidine derivatives, Typical Antipsychotic, Cytochrome P450 2D6 Inhibitors, Dopamine Antagonists, Protease Inhibitors, Decreased Central Nervous System Organized Electrical Activity, Decreased Dopamine Activity, Increased Central Nervous System Dopamine Activity.
What are the contraindications for Pimozide?
Pimozide labeling lists contraindications including: Pimozide is contraindicated in the treatment of simple tics or tics other than those associated with Tourette’s Disorder. 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 these drugs to determine whether or not the drugs, rather than Tourette’s Disorder, are responsible for the tics.. Always consult the full prescribing information and a clinician.
Note. Data for pimozide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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