Reported signals
acetaminophen, chlorpheniramine maleate, phenylephrine hcl
Registration status unknownDrugalgemeen
49,180
reports (FAERS)
46.4%
reported as serious
1,538
fatal reports (3.1%)
19
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]
Epistaxis
8.3 [7.8–8.7]
Sinusitis
6.2 [5.9–6.5]
Nasal congestion
5.4 [5.0–5.8]
Asthma
4.6 [4.3–4.9]
Bronchitis
4.1 [3.8–4.4]
Gastrooesophageal reflux disease
3.8 [3.5–4.1]
Cough
2.9 [2.8–3.1]
Anxiety
2.5 [2.3–2.6]
Chest pain
2.3 [2.2–2.5]
Dyspnoea
2.3 [2.2–2.4]
Urinary tract infection
2.2 [2.1–2.4]
Pneumonia
2.2 [2.1–2.3]
Headache
2.2 [2.1–2.3]
Depression
2.2 [2.0–2.3]
Insomnia
2.2 [2.0–2.3]
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
Epistaxis
Sinusitis
Nasal congestion
Asthma
Bronchitis
Gastrooesophageal reflux disease
Cough
Anxiety
Recall history · 0 on record
No recalls on record.
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Source & citation
HealthProves. acetaminophen, chlorpheniramine maleate, phenylephrine hcl — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/acetaminophen-chlorpheniramine-maleate-phenylephrine-hcl/
FAERS49,180 records
Retrieved2026-07-05
MethodROR / disproportionality