Duloxetine vs Paroxetine: side effects in FDA adverse event reports
At a glance
| Duloxetine | Paroxetine | |
|---|---|---|
| Drug class | – | – |
| Brand names | Duloxetine Hydrochloride | – |
| FAERS reports | 69,247 | 41,070 |
| Serious | 71% | 84% |
| Death outcome | 7,117 | 5,352 |
| 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 st | Yes Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolesc |
Signals both drugs share
| Reaction | Duloxetine | Paroxetine | Label screen (A / B) |
|---|---|---|---|
| Serotonin syndrome | 2,015 · PRR 13.1 | 1,456 · PRR 19.0 | Labeled — boxed warning / Labeled adverse reaction |
| Electric shock | 186 · PRR 31.4 | 122 · PRR 38.9 | Labeled adverse reaction / Not in label — unassessed |
Labeled signals distinctive to Duloxetine
- Hyperhidrosis — n=6,948, PRR 6.3 Labeled adverse reaction
- Suicidal ideation — n=6,330, PRR 8.3 Labeled — boxed warning
- Agitation — n=4,709, PRR 7.6 Labeled adverse reaction
- Irritability — n=4,502, PRR 9.0 Labeled adverse reaction
- Vertigo — n=3,929, PRR 7.7 Labeled adverse reaction
- Nightmare — n=2,838, PRR 9.9 Labeled adverse reaction
- Affect lability — n=2,801, PRR 45.6 Labeled (related wording)
- Mood swings — n=1,923, PRR 7.1 Labeled adverse reaction
Labeled signals distinctive to Paroxetine
- Atrial septal defect — n=1,299, PRR 42.3 Labeled adverse reaction
- Congenital anomaly — n=1,198, PRR 42.0 Labeled (related wording)
- Ventricular septal defect — n=855, PRR 40.3 Labeled adverse reaction
- Multiple congenital abnormalities — n=213, PRR 39.7 Labeled (related wording)
- Pulmonary artery stenosis congenital — n=193, PRR 82.5 Labeled (related wording)
- Cogwheel rigidity — n=120, PRR 29.7 Labeled adverse reaction
- Pulmonary valve stenosis congenital — n=88, PRR 57.6 Labeled (related wording)
- Congenital cardiovascular anomaly — n=81, PRR 24.3 Labeled (related wording)
Common questions
Which has more reported side effects, Duloxetine or Paroxetine?
Duloxetine has 69,247 FAERS reports and Paroxetine 41,070. 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 (71% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Duloxetine and Paroxetine share?
Both drugs carry disproportionality signals for serotonin syndrome, electric shock. Shared signals often reflect a shared drug class or the condition both are used for.
Is Duloxetine or Paroxetine 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.