Ibuprofen vs Diclofenac Topical: side effects in FDA adverse event reports
At a glance
| Ibuprofen | Diclofenac Topical | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | – |
| Brand names | – | Diclofenac Sodium |
| FAERS reports | 269,923 | 35,510 |
| Serious | 65% | 78% |
| Death outcome | 18,300 | 6,889 |
| 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 | Diclofenac Topical | Label screen (A / B) |
|---|---|---|---|
| Glossodynia | 3,142 · PRR 12.6 | 5,736 · PRR 204.3 | Labeled (related wording) / Labeled (related wording) |
| Duodenal ulcer perforation | 2,987 · PRR 53.0 | 3,741 · PRR 620.8 | Labeled — boxed warning / Labeled — boxed warning |
| Sleep disorder due to general medical condition, insomnia type | 2,296 · PRR 42.8 | 1,762 · PRR 223.1 | Labeled (related wording) / Labeled (related wording) |
| Subcutaneous drug absorption impaired | 200 · PRR 44.7 | 175 · PRR 280.4 | Not in label — unassessed / Labeled (related wording) |
| Pemphigus | 2,949 · PRR 23.9 | 5,732 · PRR 509.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 2,887 · PRR 21.8 | 5,238 · PRR 396.9 | Not in label — unassessed / Not in label — unassessed |
| Synovitis | 3,270 · PRR 17.0 | 4,593 · PRR 202.1 | Not in label — unassessed / Not in label — unassessed |
| Pericarditis | 3,201 · PRR 18.3 | 4,482 · PRR 217.9 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,915 · PRR 30.8 | 3,696 · PRR 337.7 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,946 · PRR 30.7 | 3,101 · PRR 254.2 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,029 · PRR 45.2 | 2,608 · PRR 276.1 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,329 · PRR 33.7 | 2,767 · PRR 1,041.6 | Likely indication confounding / Not in label — unassessed |
| Lip dry | 1,115 · PRR 10.9 | 1,679 · PRR 136.3 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 827 · PRR 27.4 | 1,628 · PRR 638.1 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 865 · PRR 61.1 | 1,238 · PRR 1,031.6 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 770 · PRR 18.4 | 1,265 · PRR 274.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 747 · PRR 45.4 | 942 · PRR 522.8 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 675 · PRR 33.6 | 944 · PRR 438.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 461 · PRR 48.8 | 840 · PRR 1,458.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 383 · PRR 22.9 | 718 · PRR 449.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Ibuprofen
- 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 Diclofenac Topical
- Wound — n=5,149, PRR 134.4 Labeled adverse reaction
- Hepatic enzyme — n=88, PRR 1,023.6 Labeled (related wording)
Common questions
Which has more reported side effects, Ibuprofen or Diclofenac Topical?
Ibuprofen has 269,923 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 (65% vs 78%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Ibuprofen and Diclofenac Topical share?
Both drugs carry disproportionality signals for glossodynia, duodenal ulcer perforation, sleep disorder due to general medical condition, insomnia type, subcutaneous drug absorption impaired, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Ibuprofen 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.