What the label lists and what reports show
Iloperidone side effects
Iloperidone's FDA label lists its adverse reactions in its own words. FAERS holds 1,470 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 dizziness (107 reports).
- Generic approved
- Boxed warning
Check it at the source: the iloperidone FDA label on DailyMed (effective May 6, 2026, Vanda Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.1) ] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] QT Prolongation [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Seizures [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia and Agranulocytosis [see Warnings and Precautions (5.10) ] Hyperprolactinemia [see Warnings and Precautions (5.11) ] …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Placebo (%) (N=587) | FANAPT 10-16 mg/day (%) (N=483) | FANAPT 20-24 mg/day (%) (N=391) |
|---|---|---|---|
| Arthralgia | 2 | 3 | 3 |
| Fatigue | 3 | 4 | 6 |
| Musculoskeletal Stiffness | 1 | 1 | 3 |
| Weight Increased | 1 | 1 | 9 |
| Tachycardia | 1 | 3 | 12 |
| Vision Blurred | 2 | 3 | 1 |
| Nausea | 8 | 7 | 10 |
| Dry Mouth | 1 | 8 | 10 |
| Diarrhea | 4 | 5 | 7 |
| Abdominal Discomfort | 1 | 1 | 3 |
| Nasopharyngitis | 3 | 4 | 3 |
| Upper Respiratory Tract Infection | 1 | 2 | 3 |
| Dizziness | 7 | 10 | 20 |
| Somnolence | 5 | 9 | 15 |
| Extrapyramidal Disorder | 4 | 5 | 4 |
| Tremor | 2 | 3 | 3 |
| Lethargy | 1 | 3 | 1 |
| Ejaculation Failure | <1 | 2 | 2 |
| Nasal Congestion | 2 | 5 | 8 |
| Dyspnea | <1 | 2 | 2 |
| Rash | 2 | 3 | 2 |
| Orthostatic Hypotension | 1 | 3 | 5 |
| Hypotension | <1 | <1 | 3 |
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, Vanda Pharmaceuticals Inc., effective May 6, 2026 (SPL set 33f60b40-3fca-11de-8f56-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,470 reports list iloperidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 60 are coded as a death and 221 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 23 reactions below, 14 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.
Reports received each year
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?
- Iloperidone: 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