Venlafaxine vs Duloxetine: side effects in FDA adverse event reports
At a glance
| Venlafaxine | Duloxetine | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | Duloxetine Hydrochloride |
| FAERS reports | 131,548 | 69,247 |
| Serious | 74% | 71% |
| Death outcome | 13,161 | 7,117 |
| Boxed warning | Yes WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children | Yes SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term st |
Signals both drugs share
| Reaction | Venlafaxine | Duloxetine | Label screen (A / B) |
|---|---|---|---|
| Serotonin syndrome | 2,520 · PRR 24.1 | 2,015 · PRR 13.1 | Labeled — boxed warning / Labeled — boxed warning |
| Hypomania | 196 · PRR 8.9 | 697 · PRR 26.0 | Labeled — boxed warning / Labeled — boxed warning |
| Electric shock sensation | 251 · PRR 16.3 | 232 · PRR 10.5 | Labeled adverse reaction / Labeled adverse reaction |
| Hostility | 154 · PRR 10.1 | 163 · PRR 7.5 | Labeled adverse reaction / Labeled adverse reaction |
| Personality disorder | 158 · PRR 10.1 | 310 · PRR 14.8 | Likely indication confounding / Not in label — unassessed |
Labeled signals distinctive to Venlafaxine
- Suicide attempt — n=3,232, PRR 8.9 Labeled — boxed warning
- Withdrawal syndrome — n=2,166, PRR 8.6 Labeled adverse reaction
- Major depression — n=745, PRR 18.0 Labeled (related wording)
- Mydriasis — n=682, PRR 8.9 Labeled adverse reaction
- Hyperreflexia — n=245, PRR 11.9 Labeled adverse reaction
- Homicidal ideation — n=235, PRR 9.7 Labeled adverse reaction
- Clonus — n=164, PRR 10.1 Labeled adverse reaction
- Anorgasmia — n=158, PRR 9.8 Labeled adverse reaction
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
Common questions
Which has more reported side effects, Venlafaxine or Duloxetine?
Venlafaxine has 131,548 FAERS reports and Duloxetine 69,247. 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 (74% vs 71%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Venlafaxine and Duloxetine share?
Both drugs carry disproportionality signals for serotonin syndrome, hypomania, electric shock sensation, hostility, personality disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Venlafaxine or Duloxetine 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.