Acetaminophen side effects: what 1,459 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,459 reports · 45% serious · 55 with death outcome · 64% female
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
Boxed warning
None in the current label
Causality screen of the 16 strongest signals
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.
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. 26 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Disease recurrence | 134 | 40.4 34.4–47.5ROR 44.4 · χ² 5,109 / p <1e-300 | 40.1 EB05 34.7 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 89% consumer | no trial data cached |
| Sinus tachycardia | 19 | 19.3 12.3–30.1ROR 19.5 · χ² 311 / p 7e-70 | 18.8 EB05 12.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.9 | no trial data cached |
| Acute hepatic failure | 14 | 14.8 8.8–24.9ROR 14.9 · χ² 166 / p 2e-38 | 13.8 EB05 7.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | no trial data cached |
| Covid-19 | 173 | 14.0 12.2–16.2ROR 15.8 · χ² 2,099 / p <1e-300 | 14.0 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 85% consumer | no trial data cached |
| Nasopharyngitis (common cold) | 131 | 10.2 8.6–12.0ROR 11.1 · χ² 1,085 / p 4e-238 | 10.0 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 76% consumer | no trial data cached |
| Lactic acidosis | 20 | 8.9 5.8–13.8ROR 9.1 · χ² 134 / p 4e-31 | 7.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 95% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 36 | 8.8 6.4–12.2ROR 9.0 · χ² 243 / p 5e-55 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 72% consumer | no trial data cached |
| Rhinorrhoea (runny nose) | 38 | 8.5 6.2–11.6ROR 8.7 · χ² 243 / p 4e-55 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 72% consumer | no trial data cached |
| Sneezing | 13 | 8.3 4.9–14.3ROR 8.4 · χ² 77 / p 9e-19 | 6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Intentional overdose | 35 | 7.9 5.7–10.9ROR 8.1 · χ² 204 / p 1e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Taste disorder | 10 | 7.2 3.9–13.3ROR 7.2 · χ² 47 / p 3e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Dysgeusia (altered taste) | 36 | 6.9 5.0–9.6ROR 7.1 · χ² 177 / p 1e-40 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 86% consumer | no trial data cached |
| Suicide attempt | 25 | 5.9 4.0–8.7ROR 6.0 · χ² 97 / p 3e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Panic attack | 14 | 5.5 3.3–9.3ROR 5.6 · χ² 47 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Throat irritation | 16 | 5.1 3.2–8.4ROR 5.2 · χ² 49 / p 1e-12 | 4.5 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Toxicity to various agents | 51 | 4.4 3.3–5.7ROR 4.5 · χ² 130 / p 2e-30 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 90% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Covid-19 | 173 | 14.0 12.2–16.2ROR 15.8 · χ² 2,099 / p <1e-300 | 14.0 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 85% consumer | no trial data cached |
| Disease recurrence | 134 | 40.4 34.4–47.5ROR 44.4 · χ² 5,109 / p <1e-300 | 40.1 EB05 34.7 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 89% consumer | no trial data cached |
| Nasopharyngitis (common cold) | 131 | 10.2 8.6–12.0ROR 11.1 · χ² 1,085 / p 4e-238 | 10.0 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 76% consumer | no trial data cached |
| Toxicity to various agents | 51 | 4.4 3.3–5.7ROR 4.5 · χ² 130 / p 2e-30 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 90% clinician | no trial data cached |
| Rhinorrhoea (runny nose) | 38 | 8.5 6.2–11.6ROR 8.7 · χ² 243 / p 4e-55 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 72% consumer | no trial data cached |
| Dysgeusia (altered taste) | 36 | 6.9 5.0–9.6ROR 7.1 · χ² 177 / p 1e-40 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 86% consumer | no trial data cached |
| Nasal congestion (stuffy nose) | 36 | 8.8 6.4–12.2ROR 9.0 · χ² 243 / p 5e-55 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 72% consumer | no trial data cached |
| Intentional overdose | 35 | 7.9 5.7–10.9ROR 8.1 · χ² 204 / p 1e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Suicide attempt | 25 | 5.9 4.0–8.7ROR 6.0 · χ² 97 / p 3e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Lactic acidosis | 20 | 8.9 5.8–13.8ROR 9.1 · χ² 134 / p 4e-31 | 7.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 95% clinician | no trial data cached |
| Sinus tachycardia | 19 | 19.3 12.3–30.1ROR 19.5 · χ² 311 / p 7e-70 | 18.8 EB05 12.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.9 | no trial data cached |
| Throat irritation | 16 | 5.1 3.2–8.4ROR 5.2 · χ² 49 / p 1e-12 | 4.5 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Panic attack | 14 | 5.5 3.3–9.3ROR 5.6 · χ² 47 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Acute hepatic failure | 14 | 14.8 8.8–24.9ROR 14.9 · χ² 166 / p 2e-38 | 13.8 EB05 7.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | no trial data cached |
| Sneezing | 13 | 8.3 4.9–14.3ROR 8.4 · χ² 77 / p 9e-19 | 6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | 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.
- Covid-19 — n=173, PRR 14.0
- Nasopharyngitis — n=131, PRR 10.2
- Lactic acidosis — n=20, PRR 8.9
- Nasal congestion — n=36, PRR 8.8
- Rhinorrhoea — n=38, PRR 8.5
- Dysgeusia — n=36, PRR 6.9
- Suicide attempt — n=25, PRR 5.9
- Toxicity to various agents — n=51, PRR 4.4
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Acetaminophen are covid-19, nasopharyngitis, toxicity to various agents, rhinorrhoea, dysgeusia, nasal congestion. 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 have an FDA boxed warning?
No. The FDA label retrieved for Acetaminophen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acetaminophen 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, 42 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.