Ibuprofen vs Naproxen: side effects in FDA adverse event reports
At a glance
| Ibuprofen | Naproxen | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | Nonsteroidal Anti-inflammatory Drug |
| Brand names | – | – |
| FAERS reports | 269,923 | 142,029 |
| Serious | 65% | 61% |
| Death outcome | 18,300 | 11,472 |
| Boxed warning | Yes Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including | Yes RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased r |
Signals both drugs share
| Reaction | Ibuprofen | Naproxen | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 2,987 · PRR 53.0 | 2,535 · PRR 77.9 | Labeled — boxed warning / Labeled — boxed warning |
| Muscle injury | 3,029 · PRR 45.2 | 2,008 · PRR 47.7 | Not in label — unassessed / Labeled (related wording) |
| Porphyria acute | 228 · PRR 15.2 | 294 · PRR 39.8 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 3,270 · PRR 17.0 | 4,156 · PRR 44.0 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 2,949 · PRR 23.9 | 2,778 · PRR 42.3 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 2,887 · PRR 21.8 | 2,837 · PRR 40.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,915 · PRR 30.8 | 2,516 · PRR 48.2 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,946 · PRR 30.7 | 2,420 · PRR 45.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,329 · PRR 33.7 | 2,066 · PRR 133.1 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 827 · PRR 27.4 | 1,649 · PRR 163.1 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 770 · PRR 18.4 | 1,263 · PRR 68.2 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 865 · PRR 61.1 | 984 · PRR 149.5 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 675 · PRR 33.6 | 953 · PRR 110.9 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 747 · PRR 45.4 | 871 · PRR 112.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 461 · PRR 48.8 | 613 · PRR 157.8 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 383 · PRR 22.9 | 426 · PRR 50.4 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 200 · PRR 44.7 | 241 · PRR 117.4 | 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 Naproxen
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Ibuprofen or Naproxen?
Ibuprofen has 269,923 FAERS reports and Naproxen 142,029. 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 61%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Ibuprofen and Naproxen share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, muscle injury, porphyria acute, synovitis, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Ibuprofen or Naproxen 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.