Drug · FAERS side-effect profile with label screen
Dextromethorphan and Quinidine side effects: what 3,616 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Dextromethorphan Hydrobromide (Stona)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,616 reports · 34% serious · 278 with death outcome · 66% 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 6No label text to screen 34
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, 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). 72 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 |
|---|---|---|---|---|---|---|
| Inability to afford medication | 101 | 60.2 49.6–73.0ROR 61.9 · calibrated p 4e-6 ✓ | 58.9 EB05 49.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 · 72% consumer | no trial data cached |
| Affect lability | 45 | 27.1 20.3–36.3ROR 27.4 · calibrated p 5e-4 ✓ | 26.7 EB05 20.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.0 | no trial data cached |
| Therapy interrupted | 161 | 13.6 11.7–15.8ROR 14.1 · calibrated p 0.009 ✓ | 13.5 EB05 11.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 79% consumer | no trial data cached |
| Crying | 83 | 13.2 10.7–16.4ROR 13.5 · calibrated p 0.012 ✓ | 13.1 EB05 10.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Drug effective for unapproved indication | 66 | 13.1 10.3–16.7ROR 13.3 · calibrated p 0.012 ✓ | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 76% consumer | no trial data cached |
| Therapeutic response unexpected | 80 | 10.3 8.3–12.8ROR 10.5 · calibrated p 0.029 ✓ | 10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Insurance issue | 26 | 10.2 6.9–14.9ROR 10.2 · calibrated p 0.036 ✓ | 9.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · 73% consumer | no trial data cached |
| Muscle spasticity | 19 | 8.9 5.7–13.9ROR 8.9 · calibrated p 0.058 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Disease recurrence | 63 | 7.7 6.0–9.8ROR 7.8 · calibrated p 0.077 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 71% consumer | no trial data cached |
| Central nervous system lesion | 18 | 7.6 4.8–12.0ROR 7.6 · calibrated p 0.094 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 | no trial data cached |
| Aggression | 63 | 7.3 5.7–9.3ROR 7.4 · calibrated p 0.089 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Multiple sclerosis relapse | 81 | 6.8 5.5–8.4ROR 6.9 · calibrated p 0.105 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Multiple sclerosis | 56 | 6.8 5.2–8.8ROR 6.9 · calibrated p 0.111 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · 72% consumer | no trial data cached |
| Lethargy | 63 | 6.4 5.0–8.1ROR 6.5 · calibrated p 0.129 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Dysphagia (difficulty swallowing) | 101 | 6.2 5.1–7.5ROR 6.3 · calibrated p 0.133 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Dementia | 29 | 6.0 4.2–8.7ROR 6.1 · calibrated p 0.158 | 5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Therapy cessation | 53 | 6.0 4.6–7.9ROR 6.1 · calibrated p 0.151 | 5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 71% consumer | no trial data cached |
| Hospice care | 10 | 5.9 3.2–10.9ROR 5.9 · calibrated p 0.194 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Serotonin syndrome | 19 | 5.8 3.7–9.0ROR 5.8 · calibrated p 0.185 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Hypersomnia | 28 | 5.7 3.9–8.2ROR 5.7 · calibrated p 0.184 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · 79% consumer | no trial data cached |
| Anger | 33 | 5.6 4.0–7.9ROR 5.7 · calibrated p 0.185 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Delusion | 15 | 5.6 3.4–9.3ROR 5.6 · calibrated p 0.202 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Aphasia (loss of speech) | 29 | 5.6 3.9–8.0ROR 5.6 · calibrated p 0.193 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Abnormal behaviour | 37 | 5.4 3.9–7.4ROR 5.4 · calibrated p 0.204 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Sedation | 24 | 5.3 3.6–8.0ROR 5.4 · calibrated p 0.215 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Agitation | 65 | 5.1 4.0–6.5ROR 5.2 · calibrated p 0.221 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Bedridden | 11 | 4.9 2.7–8.8ROR 4.9 · calibrated p 0.287 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Hallucination, visual | 17 | 4.7 2.9–7.6ROR 4.7 · calibrated p 0.293 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Product use in unapproved indication | 195 | 4.6 4.0–5.3ROR 4.8 · calibrated p 0.255 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 80% consumer | no trial data cached |
| Hallucination (hallucinations) | 56 | 4.3 3.3–5.6ROR 4.4 · calibrated p 0.321 | 4.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Activities of daily living impaired | 15 | 4.3 2.6–7.2ROR 4.3 · calibrated p 0.348 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Dysarthria (slurred speech) | 28 | 4.3 3.0–6.2ROR 4.3 · calibrated p 0.335 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Choking | 14 | 4.2 2.5–7.1ROR 4.2 · calibrated p 0.374 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Psychotic disorder | 21 | 4.1 2.7–6.3ROR 4.1 · calibrated p 0.373 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Gait inability | 23 | 4.0 2.7–6.1ROR 4.0 · calibrated p 0.387 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · 83% consumer | no trial data cached |
| Muscle twitching | 16 | 4.0 2.5–6.5ROR 4.0 · calibrated p 0.399 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Speech disorder | 36 | 4.0 2.9–5.5ROR 4.0 · calibrated p 0.387 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Hypoaesthesia oral | 10 | 3.9 2.1–7.2ROR 3.9 · calibrated p 0.445 | 3.4 EB05 2.0 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | no trial data cached |
| Drug effect decreased | 36 | 3.8 2.8–5.3ROR 3.8 · calibrated p 0.419 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Feeding disorder | 13 | 3.8 2.2–6.5ROR 3.8 · calibrated p 0.450 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | 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 |
|---|---|---|---|---|---|---|
| Fall | 207 | 3.6 3.2–4.1ROR 3.8 · calibrated p 0.425 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Product use in unapproved indication | 195 | 4.6 4.0–5.3ROR 4.8 · calibrated p 0.255 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 80% consumer | no trial data cached |
| Therapy interrupted | 161 | 13.6 11.7–15.8ROR 14.1 · calibrated p 0.009 ✓ | 13.5 EB05 11.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 79% consumer | no trial data cached |
| Somnolence (drowsiness) | 103 | 3.0 2.5–3.6ROR 3.0 · calibrated p 0.620 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Dysphagia (difficulty swallowing) | 101 | 6.2 5.1–7.5ROR 6.3 · calibrated p 0.133 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Inability to afford medication | 101 | 60.2 49.6–73.0ROR 61.9 · calibrated p 4e-6 ✓ | 58.9 EB05 49.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 · 72% consumer | no trial data cached |
| Gait disturbance | 97 | 2.9 2.4–3.6ROR 3.0 · calibrated p 0.635 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 · 71% consumer | no trial data cached |
| Product use issue | 95 | 2.9 2.4–3.6ROR 3.0 · calibrated p 0.630 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 75% consumer | no trial data cached |
| Product dose omission issue | 91 | 1.9 1.5–2.3ROR 1.9 · calibrated p 0.875 | 1.8 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 · 75% consumer | no trial data cached |
| Crying | 83 | 13.2 10.7–16.4ROR 13.5 · calibrated p 0.012 ✓ | 13.1 EB05 10.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Multiple sclerosis relapse | 81 | 6.8 5.5–8.4ROR 6.9 · calibrated p 0.105 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Therapeutic response unexpected | 80 | 10.3 8.3–12.8ROR 10.5 · calibrated p 0.029 ✓ | 10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Seizure | 74 | 3.7 3.0–4.7ROR 3.8 · calibrated p 0.423 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Drug effective for unapproved indication | 66 | 13.1 10.3–16.7ROR 13.3 · calibrated p 0.012 ✓ | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 76% consumer | no trial data cached |
| Memory impairment | 65 | 2.7 2.2–3.5ROR 2.8 · calibrated p 0.709 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 73% consumer | 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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Gentamicin Sulfate ↔ Renal Failure.
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 and Quinidine?
In FDA FAERS, the most frequently co-reported reaction terms for Dextromethorphan and Quinidine are fall, somnolence, dysphagia, inability to afford medication, gait disturbance, crying. 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 and Quinidine have an FDA boxed warning?
No. The FDA label retrieved for Dextromethorphan and Quinidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dextromethorphan and Quinidine 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, 112 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.