Drug · FAERS side-effect profile with label screen
Dextromethorphan side effects: what 7,635 FDA adverse event reports show
Drug class
Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
FDA label (Established Pharmacologic Class)
Brand names
Delsym
openFDA label
Who reports
7,635 reports · 53% serious · 1,810 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep
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 5Lab value / disease marker 1Outcome field, not a reaction 1No label text to screen 33
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 313 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 |
|---|---|---|---|---|---|---|
| Accidental overdose | 404 | 30.7 27.9–33.7ROR 32.3 · χ² 11,458 / p <1e-300 | 30.3 EB05 27.9 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.0 · 83% consumer | no trial data cached |
| Drug abuse | 722 | 23.9 22.3–25.6ROR 26.3 · χ² 15,738 / p <1e-300 | 23.7 EB05 22.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 26.0 · ♀ 33% (drug 58%) | no trial data cached |
| Serotonin syndrome | 152 | 22.0 18.8–25.7ROR 22.4 · χ² 3,001 / p <1e-300 | 21.8 EB05 19.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.1 · ♀ 23% (drug 58%) · 96% clinician | no trial data cached |
| Poisoning | 71 | 15.5 12.3–19.6ROR 15.7 · χ² 946 / p 6e-208 | 15.3 EB05 12.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.2 · ♀ 35% (drug 58%) · 94% clinician | no trial data cached |
| Mydriasis | 72 | 15.5 12.3–19.5ROR 15.6 · χ² 957 / p 2e-210 | 15.3 EB05 12.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Completed suicide (death by suicide) | 352 | 11.5 10.4–12.8ROR 12.0 · χ² 3,373 / p <1e-300 | 11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 12.5 · 99% clinician | no trial data cached |
| Toxicity to various agents | 691 | 11.3 10.6–12.2ROR 12.4 · χ² 6,533 / p <1e-300 | 11.3 EB05 10.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · 95% clinician | no trial data cached |
| Euphoric mood | 42 | 11.2 8.3–15.2ROR 11.3 · χ² 380 / p 7e-85 | 10.8 EB05 8.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · 82% consumer | no trial data cached |
| Folliculitis | 40 | 10.7 7.8–14.5ROR 10.7 · χ² 340 / p 4e-76 | 10.2 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 100% (drug 58%) · 92% clinician | no trial data cached |
| Helicobacter infection | 38 | 10.3 7.5–14.1ROR 10.3 · χ² 308 / p 4e-69 | 9.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 100% (drug 58%) · 95% clinician | no trial data cached |
| Drug toxicity | 51 | 10.2 7.7–13.4ROR 10.2 · χ² 411 / p 1e-91 | 9.8 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · 93% clinician | no trial data cached |
| Bursitis | 43 | 9.8 7.3–13.2ROR 9.9 · χ² 331 / p 4e-74 | 9.3 EB05 7.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · ♀ 97% (drug 58%) | no trial data cached |
| Cardio-respiratory arrest | 145 | 9.5 8.1–11.1ROR 9.7 · χ² 1,091 / p 2e-239 | 9.3 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 · 99% clinician | no trial data cached |
| Respiratory arrest | 92 | 9.1 7.4–11.2ROR 9.2 · χ² 655 / p 1e-144 | 8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · 93% clinician | no trial data cached |
| Respiratory depression | 36 | 8.1 5.8–11.2ROR 8.1 · χ² 216 / p 4e-49 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 9% (drug 58%) · 100% clinician | no trial data cached |
| Pemphigus | 36 | 8.0 5.7–11.0ROR 8.0 · χ² 212 / p 3e-48 | 7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · ♀ 100% (drug 58%) · 92% clinician | no trial data cached |
| Intentional overdose | 184 | 7.9 6.9–9.2ROR 8.1 · χ² 1,110 / p 1e-243 | 7.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 | no trial data cached |
| Full blood count abnormal | 30 | 7.8 5.5–11.2ROR 7.9 · χ² 172 / p 2e-39 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.3 · ♀ 100% (drug 58%) | no trial data cached |
| Eosinophilia | 49 | 7.7 5.8–10.2ROR 7.8 · χ² 279 / p 6e-63 | 7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Overdose | 597 | 7.6 7.0–8.2ROR 8.1 · χ² 3,431 / p <1e-300 | 7.5 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 74% consumer | no trial data cached |
| Hand deformity | 36 | 7.6 5.5–10.5ROR 7.6 · χ² 198 / p 2e-45 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · ♀ 100% (drug 58%) · 92% clinician | no trial data cached |
| Coeliac disease | 25 | 7.0 4.7–10.4ROR 7.0 · χ² 123 / p 9e-29 | 6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 · ♀ 100% (drug 58%) | no trial data cached |
| Autoimmune disorder | 24 | 6.9 4.6–10.3ROR 6.9 · χ² 115 / p 4e-27 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · ♀ 100% (drug 58%) · 91% clinician | no trial data cached |
| Back injury | 27 | 6.9 4.7–10.0ROR 6.9 · χ² 129 / p 3e-30 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 96% (drug 58%) | no trial data cached |
| Joint range of motion decreased | 33 | 6.8 4.8–9.5ROR 6.8 · χ² 157 / p 3e-36 | 6.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 · ♀ 100% (drug 58%) · 91% clinician | no trial data cached |
| Liver injury | 59 | 6.7 5.2–8.7ROR 6.8 · χ² 281 / p 3e-63 | 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 7.6 · ♀ 87% (drug 58%) · 100% clinician | no trial data cached |
| Pulmonary congestion | 31 | 6.4 4.5–9.2ROR 6.5 · χ² 137 / p 7e-32 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Psychomotor hyperactivity | 39 | 6.4 4.7–8.8ROR 6.5 · χ² 173 / p 7e-40 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 74% consumer | no trial data cached |
| Sleep disorder due to a general medical condition | 37 | 6.3 4.6–8.7ROR 6.3 · χ² 159 / p 9e-37 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · ♀ 100% (drug 58%) | no trial data cached |
| Obesity | 35 | 6.0 4.3–8.4ROR 6.1 · χ² 142 / p 6e-33 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 100% (drug 58%) · 91% clinician | no trial data cached |
| Sinus disorder | 43 | 6.0 4.4–8.0ROR 6.0 · χ² 172 / p 1e-39 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 100% (drug 58%) | no trial data cached |
| Pericarditis | 36 | 5.9 4.3–8.2ROR 6.0 · χ² 143 / p 3e-33 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · ♀ 100% (drug 58%) · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 20 | 5.7 3.7–8.9ROR 5.8 · χ² 74 / p 5e-18 | 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 6.7 | no trial data cached |
| Synovitis | 36 | 5.5 4.0–7.6ROR 5.5 · χ² 127 / p 8e-30 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · ♀ 100% (drug 58%) · 92% clinician | no trial data cached |
| Fibromyalgia | 48 | 5.4 4.1–7.2ROR 5.5 · χ² 169 / p 6e-39 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 98% (drug 58%) | no trial data cached |
| Myoclonus | 23 | 5.3 3.5–8.0ROR 5.3 · χ² 76 / p 1e-18 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · ♀ 10% (drug 58%) · 91% clinician | no trial data cached |
| Unresponsive to stimuli | 49 | 5.2 4.0–6.9ROR 5.3 · χ² 164 / p 9e-38 | 5.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Adverse reaction | 25 | 5.2 3.5–7.7ROR 5.2 · χ² 80 / p 2e-19 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=22 · ♀ 96% (drug 58%) | no trial data cached |
| Wound infection | 20 | 5.1 3.3–7.8ROR 5.1 · χ² 61 / p 3e-15 | 4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Ataxia | 21 | 4.8 3.2–7.4ROR 4.9 · χ² 60 / p 4e-15 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,321 | 2.8 2.6–2.9ROR 3.1 · χ² 1,573 / p <1e-300 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 · 89% consumer | no trial data cached |
| Drug abuse | 722 | 23.9 22.3–25.6ROR 26.3 · χ² 15,738 / p <1e-300 | 23.7 EB05 22.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 26.0 · ♀ 33% (drug 58%) | no trial data cached |
| Toxicity to various agents | 691 | 11.3 10.6–12.2ROR 12.4 · χ² 6,533 / p <1e-300 | 11.3 EB05 10.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · 95% clinician | no trial data cached |
| Overdose | 597 | 7.6 7.0–8.2ROR 8.1 · χ² 3,431 / p <1e-300 | 7.5 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 74% consumer | no trial data cached |
| Dizziness | 452 | 2.5 2.3–2.7ROR 2.6 · χ² 412 / p 6e-92 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · 79% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 409 | 1.7 1.6–1.9ROR 1.8 · χ² 134 / p 3e-31 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.1 · 73% consumer | no trial data cached |
| Accidental overdose | 404 | 30.7 27.9–33.7ROR 32.3 · χ² 11,458 / p <1e-300 | 30.3 EB05 27.9 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.0 · 83% consumer | no trial data cached |
| Completed suicide (death by suicide) | 352 | 11.5 10.4–12.8ROR 12.0 · χ² 3,373 / p <1e-300 | 11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 12.5 · 99% clinician | no trial data cached |
| Death | 329 | 1.0 0.9–1.2ROR 1.1 · χ² 1 / p 0.197 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.1 | no trial data cached |
| Cough | 312 | 3.1 2.7–3.4ROR 3.2 · χ² 437 / p 3e-97 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 · 73% consumer | no trial data cached |
| No adverse event | 247 | 3.8 3.4–4.3ROR 3.9 · χ² 517 / p 1e-114 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 96% consumer | no trial data cached |
| Drug interaction | 228 | 3.9 3.5–4.5ROR 4.0 · χ² 502 / p 2e-111 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Somnolence (drowsiness) | 208 | 2.8 2.5–3.2ROR 2.9 · χ² 249 / p 3e-56 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · 74% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 207 | 2.1 1.9–2.4ROR 2.2 · χ² 125 / p 3e-29 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Pneumonia (lung infection) | 201 | 1.7 1.5–2.0ROR 1.7 · χ² 59 / p 8e-15 | 1.7 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Dextromethorphan are toxicity to various agents, dizziness, diarrhoea, cough, somnolence, insomnia. 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 have an FDA boxed warning?
No. The FDA label retrieved for Dextromethorphan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dextromethorphan 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 234e6a2c-a280-4a39-8777-9316e9d681fb, effective 20260527; matched on
openfda.generic_name.exact:"DEXTROMETHORPHAN") - 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, 353 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.