Reported signals
naproxen sodium, coated tablets
Registration status unknownDrugalgemeen
13,164
reports (FAERS)
76.5%
reported as serious
3,406
fatal reports (25.9%)
0
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
No disproportionate signals with sufficient data to plot. This may indicate the substance has too few reports, or that reported effects are in line with background rates.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
No novel signals above threshold.
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. naproxen sodium, coated tablets — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/naproxen-sodium-coated-tablets/
FAERS13,164 records
Retrieved2026-07-05
MethodROR / disproportionality