Reported signals
acetaminophen 500mg
Registration status unknownDrugalgemeen
247,585
reports (FAERS)
87.3%
reported as serious
38,778
fatal reports (15.7%)
30
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Infusion related reaction
17.6 [17.2–17.9]
Completed suicide
9.5 [9.3–9.7]
Hepatic enzyme increased
9.4 [9.2–9.6]
Toxicity to various agents
9.1 [8.9–9.2]
Sinusitis
7.7 [7.5–7.9]
Intentional product use issue
7.4 [7.2–7.6]
Rheumatoid arthritis
7.4 [7.2–7.5]
Joint swelling
6.9 [6.8–7.1]
Swelling
6.9 [6.7–7.0]
Drug intolerance
6.6 [6.5–6.8]
Nasopharyngitis
4.5 [4.4–4.6]
Infection
4.3 [4.2–4.4]
Peripheral swelling
4.3 [4.2–4.4]
Confusional state
4.3 [4.2–4.4]
Acute kidney injury
4.1 [4.0–4.2]
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
Infusion related reaction
Completed suicide
Hepatic enzyme increased
Toxicity to various agents
Sinusitis
Intentional product use issue
Rheumatoid arthritis
Joint swelling
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. acetaminophen 500mg — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/acetaminophen-500mg/
FAERS247,585 records
Retrieved2026-07-05
MethodROR / disproportionality