Ibuprofen vs Tramadol: side effects in FDA adverse event reports
At a glance
| Ibuprofen | Tramadol | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | – |
| Brand names | – | Tramadol Hydrochloride |
| FAERS reports | 269,923 | 37,420 |
| Serious | 65% | 90% |
| Death outcome | 18,300 | 7,344 |
| Boxed warning | Yes Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including | 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 | Ibuprofen | Tramadol | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 2,987 · PRR 53.0 | 1,111 · PRR 100.0 | Labeled — boxed warning / Not in label — unassessed |
| Muscle injury | 3,029 · PRR 45.2 | 884 · PRR 67.6 | Not in label — unassessed / Labeled adverse reaction |
| Peripheral venous disease | 770 · PRR 18.4 | 669 · PRR 112.8 | Not in label — unassessed / Labeled (related wording) |
| Subcutaneous drug absorption impaired | 200 · PRR 44.7 | 67 · PRR 78.5 | Not in label — unassessed / Labeled (related wording) |
| Folliculitis | 2,946 · PRR 30.7 | 1,223 · PRR 75.2 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,915 · PRR 30.8 | 1,089 · PRR 67.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,329 · PRR 33.7 | 1,035 · PRR 174.3 | Likely indication confounding / Not in label — unassessed |
| Lip dry | 1,115 · PRR 10.9 | 986 · PRR 69.3 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 827 · PRR 27.4 | 868 · PRR 213.5 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 865 · PRR 61.1 | 414 · PRR 150.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 747 · PRR 45.4 | 288 · PRR 93.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 675 · PRR 33.6 | 320 · PRR 94.1 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 461 · PRR 48.8 | 276 · PRR 169.5 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 383 · PRR 22.9 | 242 · PRR 95.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Ibuprofen
- Glossodynia — n=3,142, PRR 12.6 Labeled (related wording)
- Sleep disorder due to general medical condition, insomnia type — n=2,296, PRR 42.8 Labeled (related wording)
- Fixed eruption — n=228, PRR 11.9 Labeled (related wording)
- Gastric ulcer perforation — n=216, PRR 15.8 Labeled — boxed warning
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, Ibuprofen or Tramadol?
Ibuprofen has 269,923 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 (65% vs 90%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Ibuprofen and Tramadol share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, muscle injury, peripheral venous disease, subcutaneous drug absorption impaired, folliculitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Ibuprofen 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.