Drug · FAERS side-effect profile with label screen

Dextromethorphan, Guaifenesin and Chlorpheniramine side effects: what 436 FDA adverse event reports show

Dextromethorphan Hydrobromide, Guaifenesin, Chlorpheniramine Maleate · Stona · 13 reaction terms · 78 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Stona

openFDA label

Who reports

436 reports · 81% serious · 66 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 associated with ■a cold ■inhaled irritants

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 8 strongest signals

Reporting / coding artifact 2No label text to screen 6

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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. 5 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
Aspiration	7	31.1 14.9–64.8ROR 31.6 · χ² 175 / p 3e-40	28.5 EB05 14.3 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Bursitis	7	27.9 13.4–58.2ROR 28.4 · χ² 156 / p 5e-36	25.6 EB05 12.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.4	no trial data cached
Drug exposure during pregnancy	19	26.5 17.1–41.1ROR 27.7 · χ² 442 / p 2e-98	25.9 EB05 17.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 17.6	no trial data cached
Grand mal convulsion	5	25.7 10.7–61.4ROR 26.0 · χ² 95 / p 9e-23	21.6 EB05 7.2 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.5	no trial data cached
Arteriosclerosis	5	25.5 10.7–61.0ROR 25.8 · χ² 95 / p 1e-22	21.4 EB05 7.1 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.7	no trial data cached
Myocardial ischaemia	6	25.2 11.4–55.7ROR 25.5 · χ² 116 / p 2e-27	22.2 EB05 9.0 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.9	no trial data cached
Economic problem	6	18.7 8.5–41.5ROR 19.0 · χ² 84 / p 3e-20	15.5 EB05 5.7 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Local swelling	5	13.6 5.7–32.5ROR 13.7 · χ² 46 / p 5e-12	9.2 EB05 3.4 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	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
Drug exposure during pregnancy	19	26.5 17.1–41.1ROR 27.7 · χ² 442 / p 2e-98	25.9 EB05 17.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 17.6	no trial data cached
Bursitis	7	27.9 13.4–58.2ROR 28.4 · χ² 156 / p 5e-36	25.6 EB05 12.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.4	no trial data cached
Aspiration	7	31.1 14.9–64.8ROR 31.6 · χ² 175 / p 3e-40	28.5 EB05 14.3 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Economic problem	6	18.7 8.5–41.5ROR 19.0 · χ² 84 / p 3e-20	15.5 EB05 5.7 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Myocardial ischaemia	6	25.2 11.4–55.7ROR 25.5 · χ² 116 / p 2e-27	22.2 EB05 9.0 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.9	no trial data cached
Local swelling	5	13.6 5.7–32.5ROR 13.7 · χ² 46 / p 5e-12	9.2 EB05 3.4 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Arteriosclerosis	5	25.5 10.7–61.0ROR 25.8 · χ² 95 / p 1e-22	21.4 EB05 7.1 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.7	no trial data cached
Grand mal convulsion	5	25.7 10.7–61.4ROR 26.0 · χ² 95 / p 9e-23	21.6 EB05 7.2 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.5	no trial data cached
Serotonin syndrome	4	10.1 3.8–26.7ROR 10.1 · χ² 24 / p 4e-7	5.8 EB05 2.3 · IC025 +0.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.2	no trial data cached
Mania	4	11.7 4.4–31.1ROR 11.8 · χ² 29 / p 3e-8	6.8 EB05 2.5 · IC025 +0.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.3	no trial data cached
Caesarean section	4	16.4 6.2–43.4ROR 16.5 · χ² 43 / p 2e-11	10.5 EB05 3.2 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.0	no trial data cached
Drug toxicity	3	10.4 3.4–32.3ROR 10.5 · χ² 17 / p 2e-5	5.3 EB05 1.8 · IC025 +0.1	No label text to screen label has no adverse-reaction text	serious PRR 7.7	no trial data cached
Bipolar disorder	3	13.2 4.3–40.7ROR 13.3 · χ² 23 / p 1e-6	6.7 EB05 2.1 · IC025 +0.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.7	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 Dextromethorphan Hydrobromide?

In FDA FAERS, the most frequently co-reported reaction terms for Dextromethorphan Hydrobromide are bursitis, aspiration, myocardial ischaemia, local swelling, arteriosclerosis, grand mal convulsion. 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 Dextromethorphan Hydrobromide have an FDA boxed warning?

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

Do FAERS signals prove that Dextromethorphan Hydrobromide 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 1ccc9e56-32a4-450f-8412-5814b6aef285, effective 20231128; matched on openfda.generic_name.exact:"DEXTROMETHORPHAN HYDROBROMIDE")
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, 13 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.