Acetaminophen vs Ibuprofen: side effects in FDA adverse event reports
At a glance
| Acetaminophen | Ibuprofen | |
|---|---|---|
| Drug class | – | Nonsteroidal Anti-inflammatory Drug |
| Brand names | – | – |
| FAERS reports | 444,741 | 269,923 |
| Serious | 72% | 65% |
| Death outcome | 62,469 | 18,300 |
| Boxed warning | Yes RISK OF MEDICATION ERRORS AND HEPATOTOXICITY Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors which could | Yes Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including |
Signals both drugs share
| Reaction | Acetaminophen | Ibuprofen | Label screen (A / B) |
|---|---|---|---|
| Glossodynia | 5,431 · PRR 14.9 | 3,142 · PRR 12.6 | Labeled (related wording) / Labeled (related wording) |
| Duodenal ulcer perforation | 4,564 · PRR 77.4 | 2,987 · PRR 53.0 | Not in label — unassessed / Labeled — boxed warning |
| Muscle injury | 3,986 · PRR 44.1 | 3,029 · PRR 45.2 | Labeled (related wording) / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,974 · PRR 40.0 | 2,296 · PRR 42.8 | Labeled (related wording) / Labeled (related wording) |
| Peripheral venous disease | 1,405 · PRR 25.2 | 770 · PRR 18.4 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 6,150 · PRR 24.0 | 3,270 · PRR 17.0 | Not in label — unassessed / Not in label — unassessed |
| Pericarditis | 5,346 · PRR 21.9 | 3,201 · PRR 18.3 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 5,417 · PRR 32.9 | 2,887 · PRR 21.8 | Not in label — unassessed / Not in label — unassessed |
| Irritable bowel syndrome | 4,860 · PRR 13.6 | 3,399 · PRR 14.5 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 5,229 · PRR 33.8 | 2,949 · PRR 23.9 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,707 · PRR 40.0 | 2,915 · PRR 30.8 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,524 · PRR 36.3 | 2,946 · PRR 30.7 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,807 · PRR 84.8 | 1,329 · PRR 33.7 | Not in label — unassessed / Likely indication confounding |
| Facet joint syndrome | 1,725 · PRR 56.6 | 827 · PRR 27.4 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,242 · PRR 81.4 | 865 · PRR 61.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 978 · PRR 44.0 | 747 · PRR 45.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 973 · PRR 36.2 | 675 · PRR 33.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 792 · PRR 94.1 | 461 · PRR 48.8 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 605 · PRR 26.4 | 383 · PRR 22.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Acetaminophen
- Acute hepatic failure — n=3,176, PRR 14.1 Labeled (related wording)
- Infusion site pruritus — n=670, PRR 12.7 Labeled (related wording)
- Infusion site discharge — n=465, PRR 17.3 Labeled (related wording)
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
Common questions
Which has more reported side effects, Acetaminophen or Ibuprofen?
Acetaminophen has 444,741 FAERS reports and Ibuprofen 269,923. 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 (72% vs 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Acetaminophen and Ibuprofen share?
Both drugs carry disproportionality signals for glossodynia, duodenal ulcer perforation, muscle injury, sleep disorder due to general medical condition, insomnia type, peripheral venous disease. Shared signals often reflect a shared drug class or the condition both are used for.
Is Acetaminophen or Ibuprofen 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.