fluphenazine Side Effects
Also known as: Prolixin
Analysis of 108 adverse event reports submitted to the FDA from 2007 to 2025.
Total Reports
108
Death-Related
9
8.3% of reports
Hospitalizations
46
42.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 9 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 4 |
| DEPRESSION | 3 |
| HYPERGLYCAEMIA | 3 |
| HYPONATRAEMIA | 3 |
| HYPOTENSION | 3 |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | 3 |
| PANCREATITIS HAEMORRHAGIC | 3 |
| AGITATION | 2 |
| ANXIETY | 2 |
| BRADYPNOEA | 2 |
| BRAIN OEDEMA | 2 |
| CARDIAC ARREST | 2 |
| DEATH | 2 |
| DEMENTIA | 2 |
| KETONURIA | 2 |
| LOSS OF CONSCIOUSNESS | 2 |
| OFF LABEL USE | 2 |
| PAPILLOEDEMA | 2 |
| PNEUMONIA | 2 |
| PSYCHOTIC DISORDER | 2 |
Reactions in Hospitalization Reports
Top reactions in 46 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ANXIETY | 12 |
| BLOOD PRESSURE DECREASED | 10 |
| BLOOD PRESSURE INCREASED | 10 |
| CHEST PAIN | 10 |
| SEDATION | 10 |
| DYSPNOEA | 9 |
| NIGHTMARE | 9 |
| OEDEMA PERIPHERAL | 9 |
| THINKING ABNORMAL | 9 |
| ADVERSE DRUG REACTION | 8 |
| ACUTE KIDNEY INJURY | 4 |
| COAGULOPATHY | 3 |
| DEPRESSION | 3 |
| NAUSEA | 3 |
| OVERDOSE | 3 |
| PNEUMONIA | 3 |
| PSYCHOTIC DISORDER | 3 |
| SELF-INJURIOUS IDEATION | 3 |
| SUICIDAL IDEATION | 3 |
| TRANSIENT ISCHAEMIC ATTACK | 3 |
Nearby — Related Medications
What the FAERS Data Reveals About fluphenazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 108 voluntary reports linked to fluphenazine and its brand equivalents (Prolixin), spanning 2007 through 2025. Of those, 9 (8.3%) listed death as an outcome and 46 (42.6%) 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, 50% were female and 50% male; age distribution skews toward 18-44, with 33 reports in that bracket. The single most reported reaction is sedation with 19 submissions, followed by drug ineffective and anxiety.
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.
Read our methodology — how this data is sourced, computed, and verified.