Reported signals
acetaminophen, aspirin (nsaid) and caffeine
Registration status unknownDrugalgemeen
16,793
reports (FAERS)
29.5%
reported as serious
128
fatal reports (0.8%)
17
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]
Medication overuse headache
369.9 [314.6–435.1]
Drug effective for unapproved indication
77.9 [73.9–82.2]
Product use in unapproved indication
12.0 [11.4–12.6]
Therapeutic response unexpected
9.4 [8.4–10.5]
Migraine
8.1 [7.5–8.8]
Drug ineffective for unapproved indication
5.7 [5.0–6.4]
Drug ineffective
4.4 [4.2–4.5]
Therapeutic product effect incomplete
3.2 [2.8–3.7]
Abdominal pain upper
3.1 [2.8–3.4]
Product quality issue
2.9 [2.6–3.3]
Abdominal discomfort
2.8 [2.5–3.1]
Dyspepsia
2.8 [2.4–3.2]
Overdose
2.4 [2.2–2.6]
Headache
2.3 [2.2–2.5]
Incorrect dose administered
2.3 [2.1–2.5]
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
Medication overuse headache
Drug effective for unapproved indication
Product use in unapproved indication
Therapeutic response unexpected
Migraine
Drug ineffective for unapproved indication
Drug ineffective
Therapeutic product effect incomplete
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. acetaminophen, aspirin (nsaid) and caffeine — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/acetaminophen-aspirin-nsaid-and-caffeine/
FAERS16,793 records
Retrieved2026-07-05
MethodROR / disproportionality