Drug · FAERS side-effect profile with label screen
Acetaminophen and Dextromethorphan Hbr side effects: what 4,127 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Acetaminophen (Acetaminophen)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,127 reports · 83% serious · 544 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
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 3Lab value / disease marker 3Not in label — unassessed 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.
- 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.
- 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.
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. 453 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 |
|---|---|---|---|---|---|---|
| Helicobacter infection | 123 | 62.0 52.1–73.9ROR 63.9 · χ² 7,240 / p <1e-300 | 60.7 EB05 52.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 45.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Folliculitis | 124 | 61.7 51.8–73.5ROR 63.6 · χ² 7,261 / p <1e-300 | 60.4 EB05 52.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 49.8 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Pemphigus | 123 | 50.8 42.6–60.5ROR 52.3 · χ² 5,894 / p <1e-300 | 49.9 EB05 42.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 35.1 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Hand deformity | 125 | 49.0 41.2–58.3ROR 50.5 · χ² 5,777 / p <1e-300 | 48.2 EB05 41.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 36.7 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Pericarditis | 137 | 42.1 35.7–49.7ROR 43.5 · χ² 5,416 / p <1e-300 | 41.5 EB05 36.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.3 · ♀ 94% (drug 65%) · 96% clinician | no trial data cached |
| Hypercholesterolaemia | 71 | 38.0 30.1–47.9ROR 38.6 · χ² 2,502 / p <1e-300 | 37.4 EB05 30.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Synovitis | 128 | 36.3 30.6–43.1ROR 37.4 · χ² 4,329 / p <1e-300 | 35.9 EB05 30.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Joint range of motion decreased | 87 | 33.3 27.0–41.0ROR 34.0 · χ² 2,676 / p <1e-300 | 32.9 EB05 27.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.3 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Bursitis | 72 | 30.5 24.2–38.4ROR 31.0 · χ² 2,013 / p <1e-300 | 30.1 EB05 24.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 97% (drug 65%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 125 | 28.6 24.0–34.0ROR 29.4 · χ² 3,282 / p <1e-300 | 28.3 EB05 24.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Wound infection | 60 | 28.2 21.9–36.3ROR 28.6 · χ² 1,539 / p <1e-300 | 27.8 EB05 22.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · ♀ 93% (drug 65%) · 95% clinician | no trial data cached |
| Irritable bowel syndrome | 116 | 27.7 23.2–33.2ROR 28.5 · χ² 2,949 / p <1e-300 | 27.5 EB05 23.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Autoimmune disorder | 48 | 25.6 19.3–33.9ROR 25.9 · χ² 1,105 / p 1e-242 | 25.3 EB05 19.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Wound | 135 | 24.8 21.0–29.3ROR 25.6 · χ² 3,047 / p <1e-300 | 24.6 EB05 21.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Systemic lupus erythematosus | 165 | 23.8 20.5–27.7ROR 24.8 · χ² 3,571 / p <1e-300 | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 90% (drug 65%) · 96% clinician | no trial data cached |
| Fibromyalgia | 102 | 21.4 17.7–26.0ROR 21.9 · χ² 1,960 / p <1e-300 | 21.3 EB05 18.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Liver injury | 99 | 20.9 17.2–25.4ROR 21.4 · χ² 1,849 / p <1e-300 | 20.7 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · ♀ 97% (drug 65%) · 93% clinician | no trial data cached |
| Impaired healing | 134 | 20.8 17.6–24.6ROR 21.5 · χ² 2,501 / p <1e-300 | 20.7 EB05 17.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.4 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Obesity | 62 | 19.8 15.5–25.4ROR 20.1 · χ² 1,085 / p 2e-238 | 19.6 EB05 15.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · ♀ 95% (drug 65%) · 92% clinician | no trial data cached |
| Sciatica | 61 | 19.6 15.3–25.2ROR 19.9 · χ² 1,056 / p 7e-232 | 19.4 EB05 15.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · ♀ 100% (drug 65%) · 90% clinician | no trial data cached |
| Affect lability | 35 | 18.5 13.3–25.7ROR 18.6 · χ² 559 / p 8e-124 | 18.2 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 39 | 17.9 13.1–24.5ROR 18.1 · χ² 605 / p 8e-134 | 17.7 EB05 13.4 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 14.1 · ♀ 92% (drug 65%) | no trial data cached |
| Type 2 diabetes mellitus | 118 | 17.8 14.9–21.3ROR 18.3 · χ² 1,852 / p <1e-300 | 17.7 EB05 15.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Lower respiratory tract infection | 152 | 17.1 14.6–20.0ROR 17.7 · χ² 2,285 / p <1e-300 | 17.0 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 91% (drug 65%) | no trial data cached |
| Liver function test increased | 70 | 16.7 13.3–21.1ROR 17.0 · χ² 1,017 / p 2e-223 | 16.6 EB05 13.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 94% (drug 65%) | no trial data cached |
| Lower limb fracture | 57 | 15.2 11.7–19.7ROR 15.4 · χ² 741 / p 2e-163 | 15.0 EB05 12.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 95% (drug 65%) | no trial data cached |
| Psoriatic arthropathy | 119 | 15.1 12.6–18.0ROR 15.5 · χ² 1,548 / p <1e-300 | 15.0 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Delirium | 98 | 14.4 11.9–17.6ROR 14.8 · χ² 1,211 / p 1e-265 | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 91% (drug 65%) | no trial data cached |
| Coeliac disease | 27 | 14.0 9.6–20.4ROR 14.1 · χ² 313 / p 3e-70 | 13.6 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 96% (drug 65%) · 93% clinician | no trial data cached |
| Gait inability | 87 | 13.4 10.9–16.5ROR 13.7 · χ² 984 / p 3e-216 | 13.2 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 92% (drug 65%) | no trial data cached |
| Apathy | 38 | 13.3 9.7–18.3ROR 13.4 · χ² 420 / p 1e-93 | 13.0 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 97% (drug 65%) · 95% clinician | no trial data cached |
| Prescribed overdose | 50 | 13.2 10.0–17.3ROR 13.3 · χ² 549 / p 1e-121 | 12.9 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Pulmonary fibrosis | 49 | 13.1 9.9–17.3ROR 13.2 · χ² 533 / p 4e-118 | 12.8 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 100% (drug 65%) | no trial data cached |
| Joint dislocation | 26 | 12.6 8.6–18.5ROR 12.6 · χ² 265 / p 7e-60 | 12.0 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 88% (drug 65%) | no trial data cached |
| C-reactive protein increased | 89 | 12.5 10.1–15.3ROR 12.7 · χ² 926 / p 1e-203 | 12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 161 | 12.4 10.7–14.4ROR 12.9 · χ² 1,679 / p <1e-300 | 12.3 EB05 10.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 95% (drug 65%) · 94% clinician | no trial data cached |
| Disease recurrence | 113 | 12.1 10.1–14.5ROR 12.4 · χ² 1,135 / p 4e-249 | 11.9 EB05 10.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 82% consumer | no trial data cached |
| Blood cholesterol increased | 110 | 12.0 10.0–14.4ROR 12.3 · χ² 1,099 / p 3e-241 | 11.9 EB05 10.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.4 · ♀ 92% (drug 65%) | no trial data cached |
| Back injury | 25 | 11.8 7.9–17.4ROR 11.8 · χ² 235 / p 2e-53 | 11.1 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 96% (drug 65%) · 96% clinician | no trial data cached |
| Contraindicated product administered | 69 | 11.6 9.2–14.7ROR 11.8 · χ² 660 / p 6e-146 | 11.4 EB05 9.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · ♀ 99% (drug 65%) · 96% 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 |
|---|---|---|---|---|---|---|
| Nausea | 413 | 2.7 2.4–2.9ROR 2.8 · χ² 443 / p 1e-98 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Fatigue (tiredness) | 413 | 2.7 2.5–3.0ROR 2.9 · χ² 458 / p 7e-102 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Headache | 345 | 2.8 2.5–3.1ROR 3.0 · χ² 410 / p 2e-91 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.5 | no trial data cached |
| Pain | 343 | 2.8 2.6–3.1ROR 3.0 · χ² 417 / p 5e-93 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.9 | no trial data cached |
| Pyrexia (fever) | 343 | 5.0 4.6–5.6ROR 5.4 · χ² 1,123 / p 1e-246 | 5.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Dyspnoea (shortness of breath) | 320 | 2.9 2.6–3.2ROR 3.0 · χ² 400 / p 2e-89 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Vomiting | 287 | 3.1 2.8–3.5ROR 3.3 · χ² 418 / p 3e-93 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Confusional state (confusion) | 266 | 8.4 7.4–9.4ROR 8.9 · χ² 1,727 / p <1e-300 | 8.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Dizziness | 257 | 2.6 2.3–3.0ROR 2.7 · χ² 263 / p 2e-59 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Malaise (feeling unwell) | 254 | 2.9 2.6–3.3ROR 3.1 · χ² 329 / p 7e-74 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Rash | 253 | 3.0 2.6–3.3ROR 3.1 · χ² 334 / p 5e-75 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Hypertension (high blood pressure) | 240 | 5.8 5.1–6.5ROR 6.1 · χ² 947 / p 3e-208 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 89% (drug 65%) | no trial data cached |
| Arthralgia (joint pain) | 234 | 2.9 2.5–3.3ROR 3.0 · χ² 289 / p 4e-65 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Nasopharyngitis (common cold) | 227 | 6.3 5.5–7.1ROR 6.6 · χ² 1,003 / p 2e-220 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 87% (drug 65%) | no trial data cached |
| Pneumonia (lung infection) | 214 | 3.4 3.0–3.8ROR 3.5 · χ² 359 / p 3e-80 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Helicobacter infection — n=123, PRR 62.0
- Folliculitis — n=124, PRR 61.7
- Pemphigus — n=123, PRR 50.8
- Hand deformity — n=125, PRR 49.0
- Pericarditis — n=137, PRR 42.1
- Hypercholesterolaemia — n=71, PRR 38.0
- Synovitis — n=128, PRR 36.3
- Joint range of motion decreased — n=87, PRR 33.3
- Bursitis — n=72, PRR 30.5
- Glossodynia — n=125, PRR 28.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Acetaminophen (paracetamol) ↔ Liver injury / hepatotoxicity.
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 Acetaminophen and Dextromethorphan Hbr?
In FDA FAERS, the most frequently co-reported reaction terms for Acetaminophen and Dextromethorphan Hbr are nausea, fatigue, headache, pain, pyrexia, dyspnoea. 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 Acetaminophen and Dextromethorphan Hbr have an FDA boxed warning?
No. The FDA label retrieved for Acetaminophen and Dextromethorphan Hbr has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acetaminophen and Dextromethorphan Hbr 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 004c39cd-b4f4-1cae-e063-6394a90a0697, effective 20251003; matched on
openfda.generic_name.exact:"ACETAMINOPHEN") - 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, 493 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.