Reported signals
acetaminophen and codeine
Registration status unknownDrugalgemeen
13,806
reports (FAERS)
93.0%
reported as serious
3,122
fatal reports (22.6%)
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]
Duodenal ulcer perforation
426.3 [401.3–452.9]
Anti-cyclic citrullinated peptide antibody positive
384.6 [361.2–409.5]
Muscle injury
323.8 [304.3–344.5]
Helicobacter infection
282.0 [265.9–299.1]
Folliculitis
273.7 [258.0–290.4]
Pemphigus
213.9 [201.7–226.8]
Hand deformity
198.2 [186.9–210.2]
Pericarditis
154.9 [146.2–164.2]
Dependence
145.4 [139.9–151.1]
Synovitis
138.0 [130.2–146.2]
Irritable bowel syndrome
111.1 [104.8–117.8]
Glossodynia
107.3 [101.2–113.7]
Wound
79.2 [74.6–84.0]
Impaired healing
71.7 [67.7–75.9]
Systemic lupus erythematosus
70.7 [66.9–74.8]
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
Duodenal ulcer perforation
Anti-cyclic citrullinated peptide antibody positive
Muscle injury
Helicobacter infection
Folliculitis
Pemphigus
Hand deformity
Pericarditis
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. acetaminophen and codeine — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/acetaminophen-and-codeine/
FAERS13,806 records
Retrieved2026-07-05
MethodROR / disproportionality