Escitalopram vs Fluoxetine: side effects in FDA adverse event reports
At a glance
| Escitalopram | Fluoxetine | |
|---|---|---|
| Drug class | – | – |
| Brand names | Escitalopram Oxalate | – |
| FAERS reports | 139,448 | 126,801 |
| Serious | 67% | 72% |
| Death outcome | 11,263 | 12,911 |
| Boxed warning | Yes SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studie | Yes SUICIDAL THOUGHTS AND BEHAVIORS • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term |
Signals both drugs share
| Reaction | Escitalopram | Fluoxetine | Label screen (A / B) |
|---|---|---|---|
| Serotonin syndrome | 1,668 · PRR 14.3 | 2,364 · PRR 23.2 | Labeled — boxed warning / Labeled — boxed warning |
| Major depression | 630 · PRR 14.1 | 584 · PRR 14.2 | Labeled (related wording) / Likely indication confounding |
| Urinary tract disorder | 249 · PRR 8.8 | 233 · PRR 9.0 | Labeled (related wording) / Not in label — unassessed |
| Hyperreflexia | 171 · PRR 7.7 | 212 · PRR 10.6 | Labeled adverse reaction / Labeled adverse reaction |
| Anorgasmia | 158 · PRR 9.2 | 178 · PRR 11.5 | Labeled adverse reaction / Labeled adverse reaction |
| Clonus | 145 · PRR 8.3 | 163 · PRR 10.4 | Labeled adverse reaction / Labeled adverse reaction |
| Physical deconditioning | 303 · PRR 20.6 | 292 · PRR 21.7 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 243 · PRR 44.0 | 229 · PRR 44.9 | Not in label — unassessed / Not in label — unassessed |
| Reversible cerebral vasoconstriction syndrome | 168 · PRR 14.0 | 162 · PRR 14.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Escitalopram
- Sexual dysfunction — n=558, PRR 7.5 Labeled — boxed warning
- Mite allergy — n=274, PRR 113.4 Labeled (related wording)
- Respiratory symptom — n=167, PRR 9.5 Labeled (related wording)
- Depressive symptom — n=162, PRR 7.2 Labeled (related wording)
- Electric shock sensation — n=145, PRR 8.5 Labeled adverse reaction
- Bronchial secretion retention — n=117, PRR 15.2 Labeled (related wording)
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)
- Flat affect — n=138, PRR 10.6 Labeled (related wording)
- Hostility — n=122, PRR 8.2 Labeled adverse reaction
- Congenital cardiovascular anomaly — n=97, PRR 21.2 Labeled (related wording)
Common questions
Which has more reported side effects, Escitalopram or Fluoxetine?
Escitalopram has 139,448 FAERS reports and Fluoxetine 126,801. 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 (67% vs 72%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Escitalopram and Fluoxetine share?
Both drugs carry disproportionality signals for serotonin syndrome, major depression, urinary tract disorder, hyperreflexia, anorgasmia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Escitalopram or Fluoxetine 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.