What the label lists and what reports show
Pimozide side effects
Pimozide's FDA label lists its adverse reactions in its own words. FAERS holds 471 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is parkinsonism (42 reports).
- Generic listed
Check it at the source: the pimozide FDA label on DailyMed (effective August 12, 2026, Par Health USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGeneral 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 dose-related since they occur at relatively high doses and have been shown to disappear or become less severe when the dose is reduced. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Body System/ Adverse Reaction All Events (N=36) | Number of Patients Experiencing Each Event (%) Drug-Related Events (N=36) |
|---|---|---|
| Asthenia | 9 (25.0) | 5 (13.8) |
| Headache | 8 (22.2) | 1 (2.7) |
| Dysphagia | 1 (2.7) | 1 (2.7) |
| Increased Salivation | 5 (13.8) | 2 (5.5) |
| Myalgia | 1 (2.7) | 1 (2.7) |
| Dreaming Abnormal | 1 (2.7) | 1 (2.7) |
| Hyperkinesia | 2 (5.5) | 1 (2.7) |
| Somnolence | 10 (27.7) | 9 (25.0) |
| Torticollis | 1 (2.7) | 1 (2.7) |
| Tremor, Limbs | 1 (2.7) | 1 (2.7) |
| Adverse Behavior Effect | 10 (27.7) | 8 (22.2) |
| Nervous | 3 (8.3) | 2 (5.5) |
| Rash | 3 (8.3) | 1 (2.7) |
| Visual Disturbance | 2 (5.5) | 1 (2.7) |
| ECG Abnormal | 1 (2.7) | 1 (2.7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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?
471 reports list pimozide among the medicines taken, 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. Of the 19 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pimozide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions