Ibuprofen vs Diclofenac: side effects in FDA adverse event reports
At a glance
| Ibuprofen | Diclofenac | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug | – |
| Brand names | – | Diclofenac Sodium |
| FAERS reports | 269,923 | 149,524 |
| Serious | 65% | 60% |
| Death outcome | 18,300 | 13,473 |
| 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 ris |
Signals both drugs share
| Reaction | Ibuprofen | Diclofenac | Label screen (A / B) |
|---|---|---|---|
| Glossodynia | 3,142 · PRR 12.6 | 7,814 · PRR 75.3 | Labeled (related wording) / Labeled (related wording) |
| Duodenal ulcer perforation | 2,987 · PRR 53.0 | 5,286 · PRR 370.3 | Labeled — boxed warning / Labeled — boxed warning |
| Sleep disorder due to general medical condition, insomnia type | 2,296 · PRR 42.8 | 2,635 · PRR 97.3 | Labeled (related wording) / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 200 · PRR 44.7 | 259 · PRR 127.5 | Not in label — unassessed / Labeled (related wording) |
| Pemphigus | 2,949 · PRR 23.9 | 7,999 · PRR 257.2 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 2,887 · PRR 21.8 | 7,170 · PRR 171.4 | Not in label — unassessed / Not in label — unassessed |
| Synovitis | 3,270 · PRR 17.0 | 6,658 · PRR 82.0 | Not in label — unassessed / Not in label — unassessed |
| Pericarditis | 3,201 · PRR 18.3 | 6,393 · PRR 87.3 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,915 · PRR 30.8 | 5,179 · PRR 145.6 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,946 · PRR 30.7 | 4,382 · PRR 103.5 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,029 · PRR 45.2 | 3,855 · PRR 124.7 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,329 · PRR 33.7 | 3,334 · PRR 468.1 | Likely indication confounding / Not in label — unassessed |
| Facet joint syndrome | 827 · PRR 27.4 | 2,037 · PRR 260.2 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 770 · PRR 18.4 | 1,594 · PRR 93.2 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 865 · PRR 61.1 | 1,448 · PRR 407.4 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 747 · PRR 45.4 | 1,120 · PRR 176.8 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 675 · PRR 33.6 | 1,154 · PRR 152.1 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 461 · PRR 48.8 | 955 · PRR 596.1 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 383 · PRR 22.9 | 822 · PRR 136.7 | Not in label — unassessed / Not in label — unassessed |
| Porphyria acute | 228 · PRR 15.2 | 355 · PRR 48.4 | 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
- Hepatic enzyme — n=96, PRR 313.9 Labeled (related wording)
- Intestinal diaphragm disease — n=88, PRR 65.3 Labeled (related wording)
Common questions
Which has more reported side effects, Ibuprofen or Diclofenac?
Ibuprofen has 269,923 FAERS reports and Diclofenac 149,524. 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 60%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Ibuprofen and Diclofenac 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 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.