Oxycodone vs Hydromorphone: side effects in FDA adverse event reports
At a glance
| Oxycodone | Hydromorphone | |
|---|---|---|
| Drug class | – | – |
| Brand names | Oxycodone Hydrochloride | Hydromorphone Hydrochloride |
| FAERS reports | 185,825 | 91,449 |
| Serious | 82% | 93% |
| Death outcome | 53,015 | 28,105 |
| 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 HYDROMORPHONE HYDROCHLORIDE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE S |
Signals both drugs share
| Reaction | Oxycodone | Hydromorphone | Label screen (A / B) |
|---|---|---|---|
| Retinitis | 434 · PRR 39.4 | 203 · PRR 31.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 488 · PRR 78.4 | 110 · PRR 23.3 | 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 Hydromorphone
- Drug withdrawal syndrome — n=14,329, PRR 44.1 Labeled (related wording)
- Drug withdrawal syndrome neonatal — n=2,771, PRR 52.1 Labeled (related wording)
- Substance use disorder — n=247, PRR 19.9 Labeled adverse reaction
- Vision abnormal neonatal — n=109, PRR 79.5 Labeled (related wording)
- Substance dependence — n=103, PRR 41.6 Labeled (related wording)
- Drug tolerance increased — n=75, PRR 24.1 Labeled (related wording)
- Medical device site pain — n=44, PRR 19.4 Labeled (related wording)
Common questions
Which has more reported side effects, Oxycodone or Hydromorphone?
Oxycodone has 185,825 FAERS reports and Hydromorphone 91,449. 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 93%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Oxycodone and Hydromorphone share?
Both drugs carry disproportionality signals for retinitis, lupus vulgaris. Shared signals often reflect a shared drug class or the condition both are used for.
Is Oxycodone or Hydromorphone 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.