Drug · FAERS side-effect profile with label screen
Dextromethorphan Hydrobromide and Bupropion side effects: what 3,285 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Stona
openFDA label
Who reports
3,285 reports · 23% serious · 33 with death outcome · 70% 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 5No label text to screen 35
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. 63 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 |
|---|---|---|---|---|---|---|
| Euphoric mood | 63 | 39.2 30.7–50.1ROR 40.0 · χ² 2,296 / p <1e-300 | 38.6 EB05 31.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 72% consumer | no trial data cached |
| Brain fog | 84 | 36.9 29.9–45.6ROR 37.9 · χ² 2,886 / p <1e-300 | 36.5 EB05 30.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · 75% consumer | no trial data cached |
| Drug effect less than expected | 68 | 30.9 24.4–39.1ROR 31.5 · χ² 1,930 / p <1e-300 | 30.5 EB05 24.9 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=4 · 77% consumer | no trial data cached |
| Serotonin syndrome | 50 | 16.7 12.7–22.0ROR 17.0 · χ² 722 / p 3e-159 | 16.5 EB05 13.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.5 | no trial data cached |
| Insurance issue | 37 | 15.9 11.6–21.9ROR 16.1 · χ² 502 / p 2e-111 | 15.7 EB05 11.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · 97% consumer | no trial data cached |
| Sexual dysfunction | 28 | 15.3 10.6–22.2ROR 15.5 · χ² 360 / p 1e-80 | 15.0 EB05 10.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · ♀ 13% (drug 70%) · 75% consumer | no trial data cached |
| Withdrawal syndrome | 100 | 15.1 12.5–18.4ROR 15.6 · χ² 1,306 / p 3e-286 | 15.0 EB05 12.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 78% consumer | no trial data cached |
| Therapy interrupted | 144 | 13.3 11.4–15.7ROR 13.9 · χ² 1,634 / p <1e-300 | 13.3 EB05 11.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · 94% consumer | no trial data cached |
| Sedation | 53 | 13.0 9.9–17.0ROR 13.2 · χ² 574 / p 3e-127 | 12.8 EB05 10.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 | no trial data cached |
| Mania | 32 | 12.4 8.8–17.6ROR 12.6 · χ² 325 / p 6e-73 | 12.0 EB05 8.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.3 | no trial data cached |
| Apathy | 27 | 11.9 8.2–17.3ROR 12.0 · χ² 258 / p 3e-58 | 11.2 EB05 7.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 92% consumer | no trial data cached |
| Impaired driving ability | 21 | 11.8 7.7–18.1ROR 11.9 · χ² 196 / p 6e-45 | 10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · 75% consumer | no trial data cached |
| Inability to afford medication | 15 | 9.7 5.9–16.2ROR 9.8 · χ² 109 / p 8e-26 | 8.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Tinnitus (ringing in the ears) | 69 | 9.6 7.6–12.1ROR 9.8 · χ² 522 / p 8e-116 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial data cached |
| Decreased activity | 16 | 9.5 5.8–15.6ROR 9.6 · χ² 114 / p 7e-27 | 8.2 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Feeling jittery | 28 | 9.4 6.5–13.5ROR 9.4 · χ² 201 / p 7e-46 | 8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 71% consumer | no trial data cached |
| Thinking abnormal | 25 | 8.5 5.8–12.6ROR 8.6 · χ² 159 / p 1e-36 | 7.7 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 75% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 113 | 7.9 6.6–9.4ROR 8.1 · χ² 673 / p 1e-148 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 | no trial data cached |
| Therapeutic product effect decreased | 51 | 7.3 5.6–9.6ROR 7.4 · χ² 273 / p 1e-61 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Feeling abnormal | 273 | 7.2 6.5–8.1ROR 7.8 · χ² 1,479 / p <1e-300 | 7.2 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 · 74% consumer | no trial data cached |
| Muscle twitching | 25 | 6.9 4.7–10.2ROR 7.0 · χ² 120 / p 3e-28 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Product availability issue | 24 | 6.8 4.6–10.2ROR 6.9 · χ² 114 / p 7e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 88% consumer | no trial data cached |
| Hallucination, auditory | 17 | 6.8 4.2–11.0ROR 6.9 · χ² 79 / p 4e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 | no trial data cached |
| Inappropriate schedule of product administration | 183 | 6.6 5.7–7.6ROR 6.9 · χ² 872 / p 6e-192 | 6.5 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 80% consumer | no trial data cached |
| Crying | 35 | 6.1 4.4–8.5ROR 6.2 · χ² 145 / p 1e-33 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 94% consumer | no trial data cached |
| Psychotic disorder | 28 | 6.1 4.2–8.8ROR 6.1 · χ² 113 / p 1e-26 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Panic attack | 32 | 5.6 4.0–7.9ROR 5.6 · χ² 116 / p 2e-27 | 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 6.3 | no trial data cached |
| Abnormal dreams | 24 | 5.5 3.7–8.2ROR 5.5 · χ² 84 / p 2e-20 | 5.0 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · 73% consumer | no trial data cached |
| Irritability | 49 | 5.2 3.9–6.9ROR 5.3 · χ² 162 / p 2e-37 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 73% consumer | no trial data cached |
| Paranoia | 14 | 5.2 3.1–8.7ROR 5.2 · χ² 43 / p 3e-11 | 4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Impaired work ability | 17 | 5.1 3.1–8.1ROR 5.1 · χ² 51 / p 4e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Psychomotor hyperactivity | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 37 / p 5e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Restless legs syndrome | 14 | 4.9 2.9–8.3ROR 4.9 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Hypersomnia | 22 | 4.9 3.2–7.4ROR 4.9 · χ² 65 / p 5e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 99 | 4.9 4.0–6.0ROR 5.0 · χ² 305 / p 1e-68 | 4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · 75% consumer | no trial data cached |
| Anxiety | 214 | 4.8 4.2–5.5ROR 5.1 · χ² 646 / p 9e-143 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 73% consumer | no trial data cached |
| Tremor (shaking) | 124 | 4.8 4.0–5.7ROR 4.9 · χ² 367 / p 4e-82 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Erectile dysfunction | 19 | 4.7 3.0–7.4ROR 4.7 · χ² 52 / p 3e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 | no trial data cached |
| Agitation | 54 | 4.7 3.6–6.1ROR 4.7 · χ² 153 / p 2e-35 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Depression | 160 | 4.5 3.8–5.2ROR 4.6 · χ² 432 / p 3e-96 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 · 79% consumer | 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 |
|---|---|---|---|---|---|---|
| Dizziness | 308 | 3.9 3.6–4.4ROR 4.3 · χ² 691 / p 1e-152 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Feeling abnormal | 273 | 7.2 6.5–8.1ROR 7.8 · χ² 1,479 / p <1e-300 | 7.2 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 · 74% consumer | no trial data cached |
| Anxiety | 214 | 4.8 4.2–5.5ROR 5.1 · χ² 646 / p 9e-143 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 73% consumer | no trial data cached |
| Inappropriate schedule of product administration | 183 | 6.6 5.7–7.6ROR 6.9 · χ² 872 / p 6e-192 | 6.5 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 80% consumer | no trial data cached |
| Depression | 160 | 4.5 3.8–5.2ROR 4.6 · χ² 432 / p 3e-96 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 · 79% consumer | no trial data cached |
| Therapy interrupted | 144 | 13.3 11.4–15.7ROR 13.9 · χ² 1,634 / p <1e-300 | 13.3 EB05 11.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · 94% consumer | no trial data cached |
| Tremor (shaking) | 124 | 4.8 4.0–5.7ROR 4.9 · χ² 367 / p 4e-82 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 113 | 7.9 6.6–9.4ROR 8.1 · χ² 673 / p 1e-148 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 | no trial data cached |
| Somnolence (drowsiness) | 106 | 3.4 2.8–4.1ROR 3.4 · χ² 175 / p 2e-40 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · 75% consumer | no trial data cached |
| Withdrawal syndrome | 100 | 15.1 12.5–18.4ROR 15.6 · χ² 1,306 / p 3e-286 | 15.0 EB05 12.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 78% consumer | no trial data cached |
| Hyperhidrosis (excessive sweating) | 99 | 4.9 4.0–6.0ROR 5.0 · χ² 305 / p 1e-68 | 4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · 75% consumer | no trial data cached |
| Brain fog | 84 | 36.9 29.9–45.6ROR 37.9 · χ² 2,886 / p <1e-300 | 36.5 EB05 30.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · 75% consumer | no trial data cached |
| Product use issue | 76 | 2.6 2.1–3.2ROR 2.6 · χ² 73 / p 5e-18 | 2.6 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 90% consumer | no trial data cached |
| Tinnitus (ringing in the ears) | 69 | 9.6 7.6–12.1ROR 9.8 · χ² 522 / p 8e-116 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial data cached |
| Drug effect less than expected | 68 | 30.9 24.4–39.1ROR 31.5 · χ² 1,930 / p <1e-300 | 30.5 EB05 24.9 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=4 · 77% 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: Bupropion ↔ Seizures.
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 dizziness, feeling abnormal, anxiety, depression, tremor, suicidal ideation. 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, 103 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.