Reported signals
acetaminophen, guaifenesin, and phenylephrine hydrochloride
Registration status unknownDrugalgemeen
156,094
reports (FAERS)
59.3%
reported as serious
10,200
fatal reports (6.5%)
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
10.8 [10.4–11.1]
Exposure during pregnancy
9.3 [9.0–9.6]
Chronic kidney disease
6.3 [6.1–6.5]
Sinusitis
6.2 [6.0–6.4]
Joint swelling
6.1 [5.9–6.3]
Rheumatoid arthritis
5.7 [5.5–5.9]
Peripheral swelling
5.1 [5.0–5.3]
Nasopharyngitis
4.4 [4.2–4.5]
Blood pressure increased
4.2 [4.0–4.3]
Back pain
3.7 [3.6–3.8]
Infection
3.7 [3.5–3.8]
Arthralgia
3.5 [3.5–3.6]
Abdominal discomfort
3.5 [3.4–3.6]
Weight increased
Intended effect
3.3 [3.2–3.4]
Hypersensitivity
3.2 [3.1–3.3]
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
Infusion related reaction
Exposure during pregnancy
Chronic kidney disease
Sinusitis
Joint swelling
Rheumatoid arthritis
Peripheral swelling
Nasopharyngitis
Recall history · 0 on record
No recalls on record.
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Source & citation
HealthProves. acetaminophen, guaifenesin, and phenylephrine hydrochloride — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/acetaminophen-guaifenesin-and-phenylephrine-hydrochloride/
FAERS156,094 records
Retrieved2026-07-05
MethodROR / disproportionality