Oxycodone vs Fentanyl: side effects in FDA adverse event reports
At a glance
| Oxycodone | Fentanyl | |
|---|---|---|
| Drug class | – | Opioid Agonist |
| Brand names | Oxycodone Hydrochloride | Fentanyl System |
| FAERS reports | 185,825 | 97,898 |
| Serious | 82% | 85% |
| Death outcome | 53,015 | 27,747 |
| Boxed warning | Yes SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HCl Addiction, Abuse, and Misuse Because the use of oxycodone HCl exposes patients and other users to t | Yes SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM . WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM |
Signals both drugs share
| Reaction | Oxycodone | Fentanyl | Label screen (A / B) |
|---|---|---|---|
| Victim of homicide | 121 · PRR 30.5 | 134 · PRR 66.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Oxycodone
- Glossodynia — n=3,759, PRR 22.7 Labeled (related wording)
- Muscle injury — n=3,699, PRR 92.7 Labeled (related wording)
- Sleep disorder due to general medical condition, insomnia type — n=2,636, PRR 78.2 Labeled (related wording)
- Peripheral venous disease — n=1,261, PRR 51.9 Labeled (related wording)
- Subcutaneous drug absorption impaired — n=220, PRR 76.3 Labeled (related wording)
- Steroid dependence — n=145, PRR 23.1 Labeled (related wording)
Labeled signals distinctive to Fentanyl
- Serotonin syndrome — n=1,318, PRR 15.8 Labeled adverse reaction
- Respiratory depression — n=920, PRR 17.3 Labeled — boxed warning
- Prescription drug used without a prescription — n=629, PRR 24.5 Labeled (related wording)
- Hyperthermia malignant — n=225, PRR 38.4 Labeled (related wording)
- Accidental death — n=148, PRR 18.5 Labeled (related wording)
- Intensive care unit acquired weakness — n=60, PRR 39.8 Labeled (related wording)
Common questions
Which has more reported side effects, Oxycodone or Fentanyl?
Oxycodone has 185,825 FAERS reports and Fentanyl 97,898. 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 (82% vs 85%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Oxycodone and Fentanyl share?
Both drugs carry disproportionality signals for victim of homicide. Shared signals often reflect a shared drug class or the condition both are used for.
Is Oxycodone or Fentanyl 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.