Fluoxetine vs Sertraline: side effects in FDA adverse event reports
At a glance
| Fluoxetine | Sertraline | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 126,801 | 117,789 |
| Serious | 72% | 64% |
| Death outcome | 12,911 | 8,815 |
| Boxed warning | Yes SUICIDAL THOUGHTS AND BEHAVIORS • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term | Yes SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies |
Signals both drugs share
| Reaction | Fluoxetine | Sertraline | Label screen (A / B) |
|---|---|---|---|
| Serotonin syndrome | 2,364 · PRR 23.2 | 941 · PRR 9.2 | Labeled — boxed warning / Labeled — boxed warning |
| Anorgasmia | 178 · PRR 11.5 | 125 · PRR 8.5 | Labeled adverse reaction / Not in label — unassessed |
| Flat affect | 138 · PRR 10.6 | 108 · PRR 8.8 | Labeled (related wording) / Not in label — unassessed |
| Obsessive-compulsive disorder | 595 · PRR 13.1 | 354 · PRR 8.1 | Likely indication confounding / Likely indication confounding |
| Atrial septal defect | 412 · PRR 8.5 | 526 · PRR 11.8 | Not in label — unassessed / Not in label — unassessed |
| Major depression | 584 · PRR 14.2 | 306 · PRR 7.7 | Likely indication confounding / Likely indication confounding |
| Ventricular septal defect | 295 · PRR 8.9 | 368 · PRR 12.1 | Not in label — unassessed / Not in label — unassessed |
| Talipes | 265 · PRR 15.3 | 194 · PRR 11.8 | Not in label — unassessed / Not in label — unassessed |
| Urinary tract disorder | 233 · PRR 9.0 | 182 · PRR 7.5 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 229 · PRR 44.9 | 163 · PRR 31.9 | Not in label — unassessed / Not in label — unassessed |
| Cleft palate | 117 · PRR 10.6 | 121 · PRR 11.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Fluoxetine
- Akathisia — n=682, PRR 8.6 Labeled adverse reaction
- Torsade de pointes — n=372, PRR 8.2 Labeled (related wording)
- Hyperreflexia — n=212, PRR 10.6 Labeled adverse reaction
- Clonus — n=163, PRR 10.4 Labeled adverse reaction
- Hostility — n=122, PRR 8.2 Labeled adverse reaction
- Congenital cardiovascular anomaly — n=97, PRR 21.2 Labeled (related wording)
Labeled signals distinctive to Sertraline
- Psychiatric symptom — n=319, PRR 8.0 Labeled (related wording)
- Tension — n=291, PRR 8.9 Labeled adverse reaction
- Bruxism — n=246, PRR 8.5 Labeled adverse reaction
- Hallucinations, mixed — n=233, PRR 10.4 Labeled (related wording)
- Neuritis — n=94, PRR 11.5 Labeled adverse reaction
- Bipolar i disorder — n=90, PRR 7.6 Labeled (related wording)
- Pulmonary vasculitis — n=84, PRR 33.5 Labeled (related wording)
Common questions
Which has more reported side effects, Fluoxetine or Sertraline?
Fluoxetine has 126,801 FAERS reports and Sertraline 117,789. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (72% vs 64%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Fluoxetine and Sertraline share?
Both drugs carry disproportionality signals for serotonin syndrome, anorgasmia, flat affect, obsessive-compulsive disorder, atrial septal defect. Shared signals often reflect a shared drug class or the condition both are used for.
Is Fluoxetine or Sertraline safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.