HIGH-VOLUME · SEX-BALANCED
fluoxetine Side Effects
fluoxetine (also sold as Prozac, Sarafem) is HIGH-VOLUME in this FAERS book #114 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 69% of sex-coded reports are female (40,260 F / 18,193 M).
Data updated 2026-05-15
- 64,119
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
fluoxetine reporting skew - 69% of sex-coded reports are female (40,260 F / 18,193 M). Volume band HIGH-VOLUME #114 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for fluoxetine (Prozac): 64,119 FAERS rows (2004-2025). Top named reactions: DRUG INTERACTION, TOXICITY TO VARIOUS AGENTS, NAUSEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DRUG INTERACTION leads 3,335 of 64,119 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (17,015 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (8,833 reports, 13.8%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 2,892 |
| TOXICITY TO VARIOUS AGENTS | 1,890 |
| DEATH | 1,513 |
| CARDIAC ARREST | 742 |
| DRUG ABUSE | 685 |
| CARDIO-RESPIRATORY ARREST | 675 |
| RESPIRATORY ARREST | 474 |
| DRUG INTERACTION | 368 |
| POISONING | 296 |
| OVERDOSE | 278 |
| INTENTIONAL OVERDOSE | 257 |
| DYSPNOEA | 234 |
| PNEUMONIA | 230 |
| VOMITING | 225 |
| SEPSIS | 220 |
| FALL | 207 |
| HYPOTENSION | 194 |
| MALAISE | 190 |
| COMA | 187 |
| TACHYCARDIA | 181 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (22,346, 34.9% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 1,720 |
| TOXICITY TO VARIOUS AGENTS | 1,653 |
| INTENTIONAL OVERDOSE | 1,604 |
| VOMITING | 1,160 |
| SUICIDE ATTEMPT | 1,109 |
| FALL | 1,063 |
| NAUSEA | 1,046 |
| DYSPNOEA | 1,021 |
| HYPOTENSION | 1,001 |
| SEROTONIN SYNDROME | 990 |
| FATIGUE | 906 |
| OVERDOSE | 883 |
| ANXIETY | 816 |
| DIARRHOEA | 814 |
| PNEUMONIA | 809 |
| CONFUSIONAL STATE | 798 |
| DIZZINESS | 786 |
| MALAISE | 784 |
How to read fluoxetine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 64,119 voluntary reports linked to fluoxetine (Prozac, Sarafem), 2004-2025. Death is listed on 8,833 (13.8%). Hospitalization appears on 22,346 (34.9%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with fluoxetine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 64,404 FAERS cases (Δ 285 heavier vs fluoxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 63,762 FAERS cases (Δ 357 lighter vs fluoxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 64,488 FAERS cases (Δ 369 heavier vs fluoxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 63,731 FAERS cases (Δ 388 lighter vs fluoxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 48.3 pp vs fluoxetine's DEATH-HEAVY): CASELOAD · HOSP-MID.
fluoxetine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.