Acetaminophen vs Naproxen 220Mg: side effects in FDA adverse event reports
At a glance
| Acetaminophen | Naproxen 220Mg | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | Naproxen Sodium 220Mg |
| FAERS reports | 444,741 | 13,479 |
| Serious | 72% | 77% |
| Death outcome | 62,469 | 3,768 |
| Boxed warning | Yes RISK OF MEDICATION ERRORS AND HEPATOTOXICITY Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors which could | No |
Signals both drugs share
| Reaction | Acetaminophen | Naproxen 220Mg | Label screen (A / B) |
|---|---|---|---|
| Muscle injury | 3,986 · PRR 44.1 | 1,464 · PRR 338.4 | Labeled (related wording) / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,974 · PRR 40.0 | 850 · PRR 236.9 | Labeled (related wording) / Not in label — unassessed |
| Peripheral venous disease | 1,405 · PRR 25.2 | 957 · PRR 491.8 | Labeled (related wording) / Not in label — unassessed |
| Hand deformity | 5,417 · PRR 32.9 | 1,900 · PRR 264.6 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 5,229 · PRR 33.8 | 1,831 · PRR 269.1 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,707 · PRR 40.0 | 1,742 · PRR 321.2 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 4,564 · PRR 77.4 | 1,751 · PRR 488.8 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,524 · PRR 36.3 | 1,731 · PRR 313.7 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,807 · PRR 84.8 | 1,382 · PRR 723.5 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,725 · PRR 56.6 | 1,214 · PRR 981.1 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,242 · PRR 81.4 | 870 · PRR 1,251.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 973 · PRR 36.2 | 664 · PRR 664.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 978 · PRR 44.0 | 625 · PRR 702.4 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 792 · PRR 94.1 | 523 · PRR 1,230.5 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 605 · PRR 26.4 | 362 · PRR 431.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Acetaminophen
- Glossodynia — n=5,431, PRR 14.9 Labeled (related wording)
- 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 Naproxen 220Mg
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Acetaminophen or Naproxen 220Mg?
Acetaminophen has 444,741 FAERS reports and Naproxen 220Mg 13,479. 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 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Acetaminophen and Naproxen 220Mg share?
Both drugs carry disproportionality signals for muscle injury, sleep disorder due to general medical condition, insomnia type, peripheral venous disease, hand deformity, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Acetaminophen or Naproxen 220Mg 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.