Drug · FAERS side-effect profile with label screen

Brompheniramine, Dextromethorphan and Phenylephrine side effects: what 317 FDA adverse event reports show

Brompheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride · 6 reaction terms · 184 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Brompheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride (Pediacare Childrens Cough And Cold Grape)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

317 reports · 82% serious · 22 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose

FDA label, Indications and Usage

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 5 strongest signals

Not in label — unassessed 5

What the badges mean

Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Subarachnoid haemorrhage	11	71.3 39.9–127.5ROR 73.8 · χ² 693 / p 4e-153	63.7 EB05 38.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 50.2	no trial data cached
Hemiparesis	15	58.3 35.5–95.5ROR 61.1 · χ² 788 / p 1e-173	54.4 EB05 35.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.4	no trial data cached
Cerebrovascular accident (stroke)	123	47.9 41.7–55.0ROR 77.6 · χ² 5,641 / p <1e-300	47.5 EB05 40.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Convulsion (seizure)	23	26.2 17.7–38.9ROR 28.2 · χ² 535 / p 1e-118	25.7 EB05 18.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Cerebral infarction	9	24.4 12.8–46.4ROR 25.0 · χ² 179 / p 4e-41	22.9 EB05 12.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Cerebrovascular accident (stroke)	123	47.9 41.7–55.0ROR 77.6 · χ² 5,641 / p <1e-300	47.5 EB05 40.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Convulsion (seizure)	23	26.2 17.7–38.9ROR 28.2 · χ² 535 / p 1e-118	25.7 EB05 18.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Hemiparesis	15	58.3 35.5–95.5ROR 61.1 · χ² 788 / p 1e-173	54.4 EB05 35.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.4	no trial data cached
Subarachnoid haemorrhage	11	71.3 39.9–127.5ROR 73.8 · χ² 693 / p 4e-153	63.7 EB05 38.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 50.2	no trial data cached
Cerebral infarction	9	24.4 12.8–46.4ROR 25.0 · χ² 179 / p 4e-41	22.9 EB05 12.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.2	no trial data cached
Brain neoplasm	3	21.6 7.0–66.6ROR 21.8 · χ² 40 / p 1e-10	12.7 EB05 2.9 · IC025 +0.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Cerebrovascular accident — n=123, PRR 47.9
Convulsion — n=23, PRR 26.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Brompheniramine?

In FDA FAERS, the most frequently co-reported reaction terms for Brompheniramine are cerebrovascular accident, convulsion, hemiparesis, subarachnoid haemorrhage, cerebral infarction, brain neoplasm. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Brompheniramine have an FDA boxed warning?

No. The FDA label retrieved for Brompheniramine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Brompheniramine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID fabafdc1-9dd8-4258-af49-bab1e29ad109, effective 20241230; matched on openfda.generic_name.exact:"BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 6 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.