Drug side effects
fluvoxamine Side Effects
The reactions most often reported to the FDA for fluvoxamine (also sold as Luvox), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 2,289
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 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 fluvoxamine come from 2,289 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 2,289 reports to the FDA Adverse Event Reporting System (FAERS) for fluvoxamine (Luvox): 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
2,289
Reports Mentioning Death
254
11.1% of reports — not proof the medicine caused the death
Hospitalizations
876
38.3% 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 254 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 68 |
| TOXICITY TO VARIOUS AGENTS | 42 |
| DEATH | 31 |
| DRUG INTERACTION | 29 |
| CARDIO-RESPIRATORY ARREST | 24 |
| INTENTIONAL OVERDOSE | 19 |
| OVERDOSE | 19 |
| DRUG TOXICITY | 17 |
| PULMONARY OEDEMA | 14 |
| CARDIAC ARREST | 13 |
| LOSS OF CONSCIOUSNESS | 12 |
| PNEUMONIA | 11 |
| METABOLIC ACIDOSIS | 10 |
| BRAIN OEDEMA | 8 |
| DEPRESSION | 8 |
| PULMONARY CONGESTION | 8 |
| SEPSIS | 8 |
| BLOOD PRESSURE DECREASED | 7 |
| COMA | 7 |
Reactions in Hospitalization Reports
Top reactions in 876 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 118 |
| SUICIDAL IDEATION | 59 |
| SUICIDE ATTEMPT | 58 |
| SEROTONIN SYNDROME | 47 |
| ANXIETY | 45 |
| PYREXIA | 45 |
| CONDITION AGGRAVATED | 43 |
| DEPRESSION | 42 |
| NAUSEA | 42 |
| SOMNOLENCE | 40 |
| DIZZINESS | 36 |
| HYPOTENSION | 36 |
| TREMOR | 36 |
| VOMITING | 36 |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 35 |
| FALL | 34 |
| ALANINE AMINOTRANSFERASE INCREASED | 33 |
| DIARRHOEA | 31 |
| INTENTIONAL OVERDOSE | 30 |
Nearby, Related Medications
What the FAERS Data Reveals About fluvoxamine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,289 voluntary reports linked to fluvoxamine and its brand equivalents (Luvox), spanning 2004 through 2025. Of those, 254 (11.1%) listed death as an outcome and 876 (38.3%) 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, 56% were female and 43% male; age distribution skews toward 18-44, with 643 reports in that bracket. The single most reported reaction is drug interaction with 215 submissions, followed by nausea and somnolence.
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 fluvoxamine's 2,289.
Read our methodology - how this data is sourced, computed, and verified.