Oxycodone vs Tramadol: side effects in FDA adverse event reports
At a glance
| Oxycodone | Tramadol | |
|---|---|---|
| Drug class | – | – |
| Brand names | Oxycodone Hydrochloride | Tramadol Hydrochloride |
| FAERS reports | 185,825 | 37,420 |
| Serious | 82% | 90% |
| Death outcome | 53,015 | 7,344 |
| 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 TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of tramadol hydrochl |
Signals both drugs share
| Reaction | Oxycodone | Tramadol | Label screen (A / B) |
|---|---|---|---|
| Muscle injury | 3,699 · PRR 92.7 | 884 · PRR 67.6 | Labeled (related wording) / Labeled adverse reaction |
| Peripheral venous disease | 1,261 · PRR 51.9 | 669 · PRR 112.8 | Labeled (related wording) / Labeled (related wording) |
| Subcutaneous drug absorption impaired | 220 · PRR 76.3 | 67 · PRR 78.5 | Labeled (related wording) / Labeled (related wording) |
| Folliculitis | 4,193 · PRR 77.1 | 1,223 · PRR 75.2 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 3,547 · PRR 105.8 | 1,111 · PRR 100.0 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 3,544 · PRR 60.0 | 1,089 · PRR 67.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,971 · PRR 92.9 | 1,035 · PRR 174.3 | Not in label — unassessed / Not in label — unassessed |
| Lip dry | 1,700 · PRR 26.3 | 986 · PRR 69.3 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,653 · PRR 125.0 | 868 · PRR 213.5 | Not in label — unassessed / Not in label — unassessed |
| Breast cancer stage iii | 1,241 · PRR 26.8 | 757 · PRR 74.7 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 981 · PRR 113.3 | 414 · PRR 150.1 | Not in label — unassessed / Not in label — unassessed |
| Onychomadesis | 682 · PRR 22.0 | 492 · PRR 75.2 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 725 · PRR 54.4 | 320 · PRR 94.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 747 · PRR 66.3 | 288 · PRR 93.4 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 488 · PRR 78.4 | 276 · PRR 169.5 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 434 · PRR 39.4 | 242 · PRR 95.0 | Not in label — unassessed / Not in label — unassessed |
| Hypocholesterolaemia | 112 · PRR 64.4 | 97 · PRR 258.6 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 91 · PRR 66.1 | 49 · PRR 139.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Oxycodone
- Glossodynia — n=3,759, PRR 22.7 Labeled (related wording)
- Sleep disorder due to general medical condition, insomnia type — n=2,636, PRR 78.2 Labeled (related wording)
- Steroid dependence — n=145, PRR 23.1 Labeled (related wording)
Labeled signals distinctive to Tramadol
- Dependence — n=7,827, PRR 91.9 Labeled adverse reaction
- Nasal oedema — n=208, PRR 73.5 Labeled (related wording)
Common questions
Which has more reported side effects, Oxycodone or Tramadol?
Oxycodone has 185,825 FAERS reports and Tramadol 37,420. 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 90%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Oxycodone and Tramadol share?
Both drugs carry disproportionality signals for muscle injury, peripheral venous disease, subcutaneous drug absorption impaired, folliculitis, duodenal ulcer perforation. Shared signals often reflect a shared drug class or the condition both are used for.
Is Oxycodone or Tramadol 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.