Drug · FAERS side-effect profile with label screen

Brompheniramine and Phenylephrine side effects: what 329 FDA adverse event reports show

Brompheniramine Maleate And Phenylephrine Hydrochloride · 6 reaction terms · 186 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Brompheniramine Maleate And Phenylephrine Hydrochloride (Dimetapp Cold And Allergy)

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

Who reports

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

openFDA FAERS counts, all years, deduplication not applied

Used for

temporarily relieves: nasal congestion runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever 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

No label text to screen 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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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	68.7 38.4–122.9ROR 71.0 · χ² 667 / p 2e-147	61.6 EB05 36.7 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 48.2	no trial data cached
Hemiparesis	15	56.1 34.2–92.0ROR 58.8 · χ² 758 / p 4e-167	52.6 EB05 33.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.7	no trial data cached
Cerebrovascular accident (stroke)	123	46.1 40.1–53.1ROR 73.1 · χ² 5,426 / p <1e-300	45.8 EB05 39.4 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.6	no trial data cached
Convulsion (seizure)	25	27.5 18.9–40.1ROR 29.7 · χ² 613 / p 1e-135	27.0 EB05 19.2 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.9	no trial data cached
Cerebral infarction	9	23.5 12.3–44.7ROR 24.1 · χ² 172 / p 1e-39	22.0 EB05 11.7 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.5	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	46.1 40.1–53.1ROR 73.1 · χ² 5,426 / p <1e-300	45.8 EB05 39.4 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.6	no trial data cached
Convulsion (seizure)	25	27.5 18.9–40.1ROR 29.7 · χ² 613 / p 1e-135	27.0 EB05 19.2 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.9	no trial data cached
Hemiparesis	15	56.1 34.2–92.0ROR 58.8 · χ² 758 / p 4e-167	52.6 EB05 33.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.7	no trial data cached
Subarachnoid haemorrhage	11	68.7 38.4–122.9ROR 71.0 · χ² 667 / p 2e-147	61.6 EB05 36.7 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 48.2	no trial data cached
Cerebral infarction	9	23.5 12.3–44.7ROR 24.1 · χ² 172 / p 1e-39	22.0 EB05 11.7 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.5	no trial data cached
Brain neoplasm	3	20.8 6.7–64.2ROR 21.0 · χ² 38 / p 3e-10	12.0 EB05 2.8 · IC025 +0.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.8	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 and Phenylephrine?

In FDA FAERS, the most frequently co-reported reaction terms for Brompheniramine and Phenylephrine 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 and Phenylephrine have an FDA boxed warning?

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

Do FAERS signals prove that Brompheniramine and Phenylephrine 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 47317865-4310-4f07-8815-f3130963307d, effective 20260223; matched on openfda.generic_name.exact:"BROMPHENIRAMINE MALEATE 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.