Naproxen vs Celecoxib: side effects in FDA adverse event reports
At a glance
| Naproxen | Celecoxib | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | Nonsteroidal Anti-inflammatory Drug |
| Brand names | – | – |
| FAERS reports | 142,029 | 130,858 |
| Serious | 61% | 70% |
| Death outcome | 11,472 | 12,399 |
| Boxed warning | Yes RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased r | Yes RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased ris |
Signals both drugs share
| Reaction | Naproxen | Celecoxib | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 4,156 · PRR 44.0 | 3,119 · PRR 33.4 | Not in label — unassessed / Labeled adverse reaction |
| Duodenal ulcer perforation | 2,535 · PRR 77.9 | 2,204 · PRR 68.7 | Labeled — boxed warning / Labeled — boxed warning |
| Muscle injury | 2,008 · PRR 47.7 | 1,677 · PRR 41.0 | Labeled (related wording) / Not in label — unassessed |
| Peripheral venous disease | 1,263 · PRR 68.2 | 999 · PRR 53.3 | Not in label — unassessed / Labeled (related wording) |
| Porphyria acute | 294 · PRR 39.8 | 224 · PRR 30.9 | Labeled (related wording) / Not in label — unassessed |
| Hand deformity | 2,837 · PRR 40.7 | 2,540 · PRR 38.5 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 2,778 · PRR 42.3 | 2,203 · PRR 34.4 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,516 · PRR 48.2 | 2,172 · PRR 43.2 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,420 · PRR 45.0 | 2,133 · PRR 41.6 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,066 · PRR 133.1 | 1,848 · PRR 117.8 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,649 · PRR 163.1 | 1,517 · PRR 149.4 | Not in label — unassessed / Not in label — unassessed |
| Breast cancer stage iii | 1,375 · PRR 40.0 | 1,278 · PRR 39.6 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 984 · PRR 149.5 | 1,060 · PRR 190.1 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 953 · PRR 110.9 | 702 · PRR 73.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 871 · PRR 112.6 | 696 · PRR 84.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 613 · PRR 157.8 | 603 · PRR 165.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 426 · PRR 50.4 | 404 · PRR 51.0 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 318 · PRR 58.2 | 230 · PRR 41.2 | Likely indication confounding / Likely indication confounding |
| Grip strength | 128 · PRR 183.4 | 140 · PRR 247.1 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 124 · PRR 150.8 | 116 · PRR 143.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Naproxen
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Celecoxib
- Sleep disorder due to general medical condition, insomnia type — n=1,072, PRR 31.9 Labeled (related wording)
- Drug tolerance decreased — n=445, PRR 30.1 Labeled (related wording)
Common questions
Which has more reported side effects, Naproxen or Celecoxib?
Naproxen has 142,029 FAERS reports and Celecoxib 130,858. 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 (61% vs 70%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Naproxen and Celecoxib share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, peripheral venous disease, porphyria acute. Shared signals often reflect a shared drug class or the condition both are used for.
Is Naproxen or Celecoxib 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.