Drug side effects
fluphenazine Side Effects
The reactions most often reported to the FDA for fluphenazine (also sold as Prolixin), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 108
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2007 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 fluphenazine come from 108 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 108 reports to the FDA Adverse Event Reporting System (FAERS) for fluphenazine (Prolixin): 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
108
Reports Mentioning Death
9
8.3% of reports — not proof the medicine caused the death
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 |
| 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 anxiety and suicide attempt.
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to fluphenazine's 108.
Read our methodology - how this data is sourced, computed, and verified.