Naproxen vs Diclofenac Topical: side effects in FDA adverse event reports
At a glance
| Naproxen | Diclofenac Topical | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | – |
| Brand names | – | Diclofenac Sodium |
| FAERS reports | 142,029 | 35,510 |
| Serious | 61% | 78% |
| Death outcome | 11,472 | 6,889 |
| 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 r |
Signals both drugs share
| Reaction | Naproxen | Diclofenac Topical | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 2,535 · PRR 77.9 | 3,741 · PRR 620.8 | Labeled — boxed warning / Labeled — boxed warning |
| Muscle injury | 2,008 · PRR 47.7 | 2,608 · PRR 276.1 | Labeled (related wording) / Not in label — unassessed |
| Porphyria acute | 294 · PRR 39.8 | 320 · PRR 178.4 | Labeled (related wording) / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 241 · PRR 117.4 | 175 · PRR 280.4 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 4,156 · PRR 44.0 | 4,593 · PRR 202.1 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 2,778 · PRR 42.3 | 5,732 · PRR 509.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 2,837 · PRR 40.7 | 5,238 · PRR 396.9 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,516 · PRR 48.2 | 3,696 · PRR 337.7 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,420 · PRR 45.0 | 3,101 · PRR 254.2 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,066 · PRR 133.1 | 2,767 · PRR 1,041.6 | Likely indication confounding / Not in label — unassessed |
| Facet joint syndrome | 1,649 · PRR 163.1 | 1,628 · PRR 638.1 | Not in label — unassessed / Not in label — unassessed |
| Breast cancer stage iii | 1,375 · PRR 40.0 | 1,348 · PRR 156.7 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 1,263 · PRR 68.2 | 1,265 · PRR 274.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 984 · PRR 149.5 | 1,238 · PRR 1,031.6 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 953 · PRR 110.9 | 944 · PRR 438.5 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 871 · PRR 112.6 | 942 · PRR 522.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 613 · PRR 157.8 | 840 · PRR 1,458.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 426 · PRR 50.4 | 718 · PRR 449.0 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 318 · PRR 58.2 | 353 · PRR 271.9 | Likely indication confounding / Not in label — unassessed |
| Grip strength | 128 · PRR 183.4 | 144 · PRR 985.3 | 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 Diclofenac Topical
- Glossodynia — n=5,736, PRR 204.3 Labeled (related wording)
- Wound — n=5,149, PRR 134.4 Labeled adverse reaction
- Sleep disorder due to general medical condition, insomnia type — n=1,762, PRR 223.1 Labeled (related wording)
- Hepatic enzyme — n=88, PRR 1,023.6 Labeled (related wording)
Common questions
Which has more reported side effects, Naproxen or Diclofenac Topical?
Naproxen has 142,029 FAERS reports and Diclofenac Topical 35,510. 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 78%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Naproxen and Diclofenac Topical share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, muscle injury, porphyria acute, subcutaneous drug absorption impaired, synovitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Naproxen or Diclofenac Topical 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.