Fluoxetine vs Escitalopram Oxalate: side effects in FDA adverse event reports
At a glance
| Fluoxetine | Escitalopram Oxalate | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | Escitalopram |
| FAERS reports | 126,801 | 72,460 |
| Serious | 72% | 78% |
| Death outcome | 12,911 | 7,343 |
| 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 behaviors in pediatric and young adult patients in short-term studie |
Signals both drugs share
| Reaction | Fluoxetine | Escitalopram Oxalate | Label screen (A / B) |
|---|---|---|---|
| Serotonin syndrome | 2,364 · PRR 23.2 | 1,460 · PRR 23.8 | Labeled — boxed warning / Labeled — boxed warning |
| Major depression | 584 · PRR 14.2 | 434 · PRR 18.2 | Likely indication confounding / Labeled (related wording) |
| Urinary tract disorder | 233 · PRR 9.0 | 219 · PRR 14.8 | Not in label — unassessed / Labeled (related wording) |
| Hyperreflexia | 212 · PRR 10.6 | 152 · PRR 13.1 | Labeled adverse reaction / Labeled adverse reaction |
| Clonus | 163 · PRR 10.4 | 135 · PRR 14.9 | Labeled adverse reaction / Labeled adverse reaction |
| Physical deconditioning | 292 · PRR 21.7 | 295 · PRR 38.5 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 229 · PRR 44.9 | 242 · PRR 84.6 | Not in label — unassessed / Not in label — unassessed |
| Reversible cerebral vasoconstriction syndrome | 162 · PRR 14.8 | 165 · PRR 26.5 | 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)
- Anorgasmia — n=178, PRR 11.5 Labeled adverse reaction
- 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)
Labeled signals distinctive to Escitalopram Oxalate
- Mite allergy — n=274, PRR 218.9 Labeled (related wording)
- Suspected suicide — n=212, PRR 13.4 Labeled (related wording)
- Respiratory symptom — n=161, PRR 17.6 Labeled (related wording)
- Bronchial secretion retention — n=112, PRR 28.0 Labeled (related wording)
- Genital hypoaesthesia — n=61, PRR 18.6 Labeled (related wording)
Common questions
Which has more reported side effects, Fluoxetine or Escitalopram Oxalate?
Fluoxetine has 126,801 FAERS reports and Escitalopram Oxalate 72,460. 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 78%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Fluoxetine and Escitalopram Oxalate share?
Both drugs carry disproportionality signals for serotonin syndrome, major depression, urinary tract disorder, hyperreflexia, clonus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Fluoxetine or Escitalopram Oxalate 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.