Fluoxetine vs Bupropion: side effects in FDA adverse event reports
At a glance
| Fluoxetine | Bupropion | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 126,801 | 98,116 |
| Serious | 72% | 51% |
| Death outcome | 12,911 | 4,722 |
| 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; AND NEUROPSYCHIATRIC REACTIONS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinki |
Signals both drugs share
| Reaction | Fluoxetine | Bupropion | Label screen (A / B) |
|---|---|---|---|
| Major depression | 584 · PRR 14.2 | 276 · PRR 8.3 | Likely indication confounding / Labeled (related wording) |
| Hostility | 122 · PRR 8.2 | 131 · PRR 11.4 | Labeled adverse reaction / Labeled adverse reaction |
| Gambling disorder | 133 · PRR 8.5 | 134 · PRR 11.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Fluoxetine
- Serotonin syndrome — n=2,364, PRR 23.2 Labeled — boxed warning
- 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
- Anorgasmia — n=178, PRR 11.5 Labeled adverse reaction
- Clonus — n=163, PRR 10.4 Labeled adverse reaction
- Flat affect — n=138, PRR 10.6 Labeled (related wording)
- Congenital cardiovascular anomaly — n=97, PRR 21.2 Labeled (related wording)
Labeled signals distinctive to Bupropion
- Hallucinations, mixed — n=203, PRR 10.8 Labeled (related wording)
- Depressive symptom — n=140, PRR 8.8 Labeled (related wording)
- Libido increased — n=113, PRR 12.5 Labeled (related wording)
Common questions
Which has more reported side effects, Fluoxetine or Bupropion?
Fluoxetine has 126,801 FAERS reports and Bupropion 98,116. 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 51%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Fluoxetine and Bupropion share?
Both drugs carry disproportionality signals for major depression, hostility, gambling disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Fluoxetine or Bupropion 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.