Drug · FAERS side-effect profile with label screen
Dextromethorphan Hydrobromide side effects: what 2,991 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Stona
openFDA label
Who reports
2,991 reports · 75% serious · 988 with death outcome · 49% 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 40 strongest signals
Reporting / coding artifact 7Outcome field, not a reaction 1No label text to screen 32
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 136 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug toxicity | 79 | 40.3 32.4–50.1ROR 41.3 · calibrated p 5e-5 ✓ | 39.7 EB05 32.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · 98% clinician | no trial data cached |
| Folliculitis | 43 | 29.3 21.7–39.4ROR 29.7 · calibrated p 4e-4 ✓ | 28.8 EB05 22.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Serotonin syndrome | 78 | 28.7 23.0–35.7ROR 29.4 · calibrated p 3e-4 ✓ | 28.4 EB05 23.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · ♀ 19% (drug 49%) · 93% clinician | no trial data cached |
| Helicobacter infection | 38 | 26.2 19.1–35.9ROR 26.5 · calibrated p 7e-4 ✓ | 25.8 EB05 19.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 · ♀ 97% (drug 49%) · 95% clinician | no trial data cached |
| Pemphigus | 41 | 23.2 17.1–31.4ROR 23.5 · calibrated p 0.001 ✓ | 22.9 EB05 17.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 100% (drug 49%) · 98% clinician | no trial data cached |
| Drug abuse | 272 | 22.8 20.4–25.6ROR 25.0 · calibrated p 7e-4 ✓ | 22.7 EB05 20.5 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 · 93% clinician | no trial data cached |
| Autoimmune disorder | 31 | 22.7 16.0–32.3ROR 23.0 · calibrated p 0.001 ✓ | 22.4 EB05 16.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 · ♀ 100% (drug 49%) · 97% clinician | no trial data cached |
| Hand deformity | 36 | 19.3 13.9–26.7ROR 19.5 · calibrated p 0.003 ✓ | 19.1 EB05 14.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 · ♀ 100% (drug 49%) · 97% clinician | no trial data cached |
| Bursitis | 32 | 18.6 13.2–26.3ROR 18.8 · calibrated p 0.003 ✓ | 18.3 EB05 13.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.8 · ♀ 100% (drug 49%) · 94% clinician | no trial data cached |
| Joint range of motion decreased | 35 | 18.4 13.2–25.5ROR 18.6 · calibrated p 0.004 ✓ | 18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 100% (drug 49%) · 97% clinician | no trial data cached |
| Respiratory arrest | 72 | 18.2 14.5–22.8ROR 18.6 · calibrated p 0.003 ✓ | 18.0 EB05 14.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · 100% clinician | no trial data cached |
| Mydriasis | 31 | 17.0 11.9–24.1ROR 17.1 · calibrated p 0.005 ✓ | 16.7 EB05 12.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · ♀ 28% (drug 49%) | no trial data cached |
| Completed suicide (death by suicide) | 179 | 14.9 12.9–17.2ROR 15.8 · calibrated p 0.006 ✓ | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.4 · 96% clinician | no trial data cached |
| Pericarditis | 35 | 14.7 10.6–20.5ROR 14.9 · calibrated p 0.009 ✓ | 14.4 EB05 10.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 100% (drug 49%) · 97% clinician | no trial data cached |
| Fibromyalgia | 47 | 13.6 10.2–18.0ROR 13.8 · calibrated p 0.011 ✓ | 13.3 EB05 10.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 100% (drug 49%) · 94% clinician | no trial data cached |
| Liver injury | 44 | 12.8 9.5–17.1ROR 12.9 · calibrated p 0.015 ✓ | 12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 · ♀ 89% (drug 49%) · 93% clinician | no trial data cached |
| Sciatica | 28 | 12.4 8.6–17.9ROR 12.5 · calibrated p 0.018 ✓ | 11.8 EB05 8.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 · ♀ 100% (drug 49%) · 96% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 38 | 11.9 8.7–16.3ROR 12.1 · calibrated p 0.019 ✓ | 11.5 EB05 8.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Intentional drug misuse | 36 | 11.9 8.6–16.5ROR 12.0 · calibrated p 0.020 ✓ | 11.5 EB05 8.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 16.3 · ♀ 14% (drug 49%) · 96% clinician | no trial data cached |
| Irritable bowel syndrome | 36 | 11.8 8.5–16.3ROR 11.9 · calibrated p 0.020 ✓ | 11.4 EB05 8.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 97% (drug 49%) · 100% clinician | no trial data cached |
| Synovitis | 30 | 11.7 8.2–16.6ROR 11.8 · calibrated p 0.022 ✓ | 11.1 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 · ♀ 100% (drug 49%) · 97% clinician | no trial data cached |
| Poisoning | 19 | 10.6 6.7–16.5ROR 10.6 · calibrated p 0.034 ✓ | 9.5 EB05 6.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 | no trial data cached |
| Cardio-respiratory arrest | 61 | 10.2 7.9–13.0ROR 10.3 · calibrated p 0.031 ✓ | 9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · 97% clinician | no trial data cached |
| Pulmonary congestion | 19 | 10.1 6.4–15.8ROR 10.1 · calibrated p 0.040 ✓ | 9.0 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Toxicity to various agents | 237 | 9.9 8.8–11.2ROR 10.7 · calibrated p 0.026 ✓ | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · 95% clinician | no trial data cached |
| Interstitial lung disease | 68 | 9.9 7.8–12.5ROR 10.1 · calibrated p 0.034 ✓ | 9.6 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Intentional overdose | 86 | 9.5 7.7–11.6ROR 9.7 · calibrated p 0.038 ✓ | 9.2 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Disseminated intravascular coagulation | 19 | 9.4 6.0–14.8ROR 9.5 · calibrated p 0.049 ✓ | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Obesity | 21 | 9.2 6.0–14.1ROR 9.3 · calibrated p 0.051 | 8.2 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 95% clinician | no trial data cached |
| Lower limb fracture | 25 | 9.2 6.2–13.6ROR 9.2 · calibrated p 0.050 ✓ | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 91% (drug 49%) · 96% clinician | no trial data cached |
| Erythema multiforme | 12 | 9.0 5.1–15.9ROR 9.1 · calibrated p 0.062 | 7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Liver disorder | 57 | 9.0 7.0–11.7ROR 9.2 · calibrated p 0.047 ✓ | 8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 75% (drug 49%) · 94% clinician | no trial data cached |
| Type 2 diabetes mellitus | 41 | 8.5 6.3–11.5ROR 8.6 · calibrated p 0.058 | 8.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Paranoia | 21 | 8.5 5.5–13.0ROR 8.5 · calibrated p 0.065 | 7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · ♀ 15% (drug 49%) | no trial data cached |
| Accidental overdose | 44 | 8.4 6.3–11.3ROR 8.5 · calibrated p 0.059 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
| Exposure during pregnancy | 73 | 8.2 6.6–10.3ROR 8.4 · calibrated p 0.060 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 99% clinician | no trial data cached |
| Euphoric mood | 12 | 8.2 4.6–14.4ROR 8.2 · calibrated p 0.083 | 6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Contraindicated product administered | 34 | 7.9 5.7–11.0ROR 8.0 · calibrated p 0.075 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · ♀ 96% (drug 49%) | no trial data cached |
| Impaired healing | 37 | 7.9 5.7–10.9ROR 8.0 · calibrated p 0.074 | 7.3 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 97% (drug 49%) · 95% clinician | no trial data cached |
| Wound | 31 | 7.8 5.5–11.1ROR 7.9 · calibrated p 0.078 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · ♀ 100% (drug 49%) · 97% clinician | 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 abuse | 272 | 22.8 20.4–25.6ROR 25.0 · calibrated p 7e-4 ✓ | 22.7 EB05 20.5 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 · 93% clinician | no trial data cached |
| Toxicity to various agents | 237 | 9.9 8.8–11.2ROR 10.7 · calibrated p 0.026 ✓ | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · 95% clinician | no trial data cached |
| Completed suicide (death by suicide) | 179 | 14.9 12.9–17.2ROR 15.8 · calibrated p 0.006 ✓ | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.4 · 96% clinician | no trial data cached |
| Drug interaction | 91 | 4.0 3.3–4.9ROR 4.1 · calibrated p 0.363 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Overdose | 89 | 2.9 2.3–3.5ROR 2.9 · calibrated p 0.652 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Intentional overdose | 86 | 9.5 7.7–11.6ROR 9.7 · calibrated p 0.038 ✓ | 9.2 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Drug toxicity | 79 | 40.3 32.4–50.1ROR 41.3 · calibrated p 5e-5 ✓ | 39.7 EB05 32.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · 98% clinician | no trial data cached |
| Serotonin syndrome | 78 | 28.7 23.0–35.7ROR 29.4 · calibrated p 3e-4 ✓ | 28.4 EB05 23.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · ♀ 19% (drug 49%) · 93% clinician | no trial data cached |
| Intentional product misuse | 76 | 6.1 4.9–7.7ROR 6.3 · calibrated p 0.139 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 28% (drug 49%) · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 75 | 6.3 5.1–7.9ROR 6.5 · calibrated p 0.127 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 · 99% clinician | no trial data cached |
| Exposure during pregnancy | 73 | 8.2 6.6–10.3ROR 8.4 · calibrated p 0.060 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 99% clinician | no trial data cached |
| Respiratory arrest | 72 | 18.2 14.5–22.8ROR 18.6 · calibrated p 0.003 ✓ | 18.0 EB05 14.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · 100% clinician | no trial data cached |
| Interstitial lung disease | 68 | 9.9 7.8–12.5ROR 10.1 · calibrated p 0.034 ✓ | 9.6 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Injury | 61 | 6.0 4.7–7.8ROR 6.2 · calibrated p 0.147 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · ♀ 94% (drug 49%) · 98% clinician | no trial data cached |
| Cardio-respiratory arrest | 61 | 10.2 7.9–13.0ROR 10.3 · calibrated p 0.031 ✓ | 9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · 97% clinician | 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 toxicity to various agents, drug toxicity, serotonin syndrome, cardiac arrest, respiratory arrest, interstitial lung disease. 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, fieldpatient.drug.openfda.generic_name.exact, 176 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 2026-10-14. 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.