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Drug side effects

iloperidone Side Effects

The reactions most often reported to the FDA for iloperidone (also sold as Fanapt), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

1,388
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2009 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of iloperidone come from 1,388 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 1,388 reports to the FDA Adverse Event Reporting System (FAERS) for iloperidone (Fanapt): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

1,388

Reports Mentioning Death

59

4.3% of reports — not proof the medicine caused the death

Hospitalizations

216

15.6% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DIZZINESS
99
INSOMNIA
83
WEIGHT INCREASED
76
ANXIETY
68
FATIGUE
66
DYSKINESIA
51
NAUSEA
50
SUICIDAL IDEATION
48
DYSPNOEA
47
SOMNOLENCE
47
AGGRESSION
45
SPEECH DISORDER
40
VOMITING
40
FALL
38
TACHYCARDIA
38
ORTHOSTATIC HYPOTENSION
37
HEADACHE
36
SLEEP DISORDER
35

Who Reports Side Effects

Gender Distribution

Female 622 (51%)
Male 596 (49%)
Unknown 9

Age Distribution

0-17 61 (10%)
18-44 327 (55%)
45-64 163 (27%)
65-74 39 (7%)
75+ 7 (1%)

Reporting Trend by Year

2009 2025

Reactions in Death Reports

Top reactions reported in 59 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 26
PULMONARY EMBOLISM 7
COMPLETED SUICIDE 5
COMA 4
PNEUMONIA 4
ROAD TRAFFIC ACCIDENT 4
SUDDEN DEATH 4
TACHYCARDIA 4
BRAIN DEATH 3
CARDIAC ARREST 3
PRIAPISM 3
ARRHYTHMIA 2
DIZZINESS 2
HERPES ZOSTER 2
HYPOTENSION 2
NEOPLASM MALIGNANT 2
RESPIRATORY ARREST 2
SUDDEN CARDIAC DEATH 2
SUICIDAL IDEATION 2
WEIGHT INCREASED 2

Reactions in Hospitalization Reports

Top reactions in 216 reports where hospitalization was an outcome.

Reaction Reports
WEIGHT INCREASED 15
ASTHENIA 13
DIZZINESS 13
DYSPNOEA 13
TACHYCARDIA 13
ANXIETY 12
HEADACHE 9
PRIAPISM 9
PSYCHOTIC DISORDER 9
SYNCOPE 9
CONFUSIONAL STATE 8
HYPOTENSION 8
INSOMNIA 8
NAUSEA 8
SKIN DISCOLOURATION 8
SPEECH DISORDER 8
VEIN DISCOLOURATION 8
ABNORMAL BEHAVIOUR 7
ANGIOEDEMA 7

Compare iloperidone vs acamprosate →

What the FAERS Data Reveals About iloperidone Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 1,388 voluntary reports linked to iloperidone and its brand equivalents (Fanapt), spanning 2009 through 2025. Of those, 59 (4.3%) listed death as an outcome and 216 (15.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 49% male; age distribution skews toward 18-44, with 327 reports in that bracket. The single most reported reaction is dizziness with 99 submissions, followed by insomnia and weight increased.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.