Acetaminophen 500Mg side effects: what 253,706 FDA adverse event reports show

Acetaminophen 500Mg · 1,202 reaction terms · 1,538,720 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

253,706 reports · 87% serious · 49,999 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache arthritis menstrual cramps temporarily reduces fever

FDA label, Indications and Usage

What it is

Paracetamol is a member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

PubChem CID 1983 (ChEBI)

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 1Lab value / disease marker 10No label text to screen 29

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.
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). 1,162 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pyroglutamic acidosis	287	262.6 206.8–333.5ROR 262.9 · calibrated p 6e-11 ✓	62.1 EB05 56.3 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=286 · 100% clinician	no trial arm names this drug
Vaginal flatulence	223	227.3 175.9–293.8ROR 227.5 · calibrated p 2e-10 ✓	59.9 EB05 53.6 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=223 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Appendicolith	276	224.5 178.4–282.4ROR 224.7 · calibrated p 2e-10 ✓	59.8 EB05 54.1 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=276 · ♀ 0% (drug 62%) · 100% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody	416	137.9 117.7–161.5ROR 138.1 · calibrated p 1e-8 ✓	51.3 EB05 47.3 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious n=416 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive	4,399	135.4 129.0–142.1ROR 137.8 · calibrated p 9e-9 ✓	51.1 EB05 49.9 · IC025 +5.6 3/3 methods agree	Lab value / disease marker	serious PRR 33.8 · ♀ 100% (drug 62%) · 94% clinician	no trial arm names this drug
Rheumatic fever	2,684	132.8 124.8–141.2ROR 134.2 · calibrated p 1e-8 ✓	50.7 EB05 49.1 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2,683 · ♀ 100% (drug 62%) · 94% clinician	no trial arm names this drug
Deep vein thrombosis postoperative	1,180	125.7 114.7–137.7ROR 126.3 · calibrated p 2e-8 ✓	49.7 EB05 47.3 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1,180 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Swollen joint count increased	1,875	125.4 116.7–134.8ROR 126.3 · calibrated p 2e-8 ✓	49.6 EB05 47.8 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=1,873 · ♀ 100% (drug 62%) · 96% clinician	no trial arm names this drug
Duodenal ulcer perforation	4,404	124.8 119.1–130.8ROR 127.0 · calibrated p 2e-8 ✓	49.5 EB05 48.3 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.6 · ♀ 100% (drug 62%) · 94% clinician	no trial arm names this drug
C-reactive protein	532	117.7 103.0–134.5ROR 117.9 · calibrated p 4e-8 ✓	48.3 EB05 45.0 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious n=532 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Lupus vulgaris	689	114.2 101.7–128.2ROR 114.5 · calibrated p 4e-8 ✓	47.7 EB05 44.8 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=689 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Exposure to toxic agent	1,696	92.0 85.8–98.7ROR 92.6 · calibrated p 2e-7 ✓	43.5 EB05 41.8 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1,690 · 100% clinician	no trial arm names this drug
Facet joint syndrome	1,632	88.8 82.8–95.3ROR 89.4 · calibrated p 3e-7 ✓	42.7 EB05 41.0 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1,631 · ♀ 100% (drug 62%) · 95% clinician	no trial arm names this drug
Blood pressure diastolic abnormal	1,292	83.6 77.3–90.3ROR 84.0 · calibrated p 4e-7 ✓	41.5 EB05 39.6 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=1,259 · 90% clinician	no trial arm names this drug
Blood pressure systolic abnormal	1,191	75.7 69.9–81.9ROR 76.0 · calibrated p 9e-7 ✓	39.5 EB05 37.6 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=1,156 · 91% clinician	no trial arm names this drug
Rheumatoid factor positive	2,748	75.1 71.3–79.1ROR 75.9 · calibrated p 8e-7 ✓	39.3 EB05 38.1 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=2,747 · ♀ 100% (drug 62%) · 95% clinician	no trial arm names this drug
Muscle injury	3,742	69.1 66.2–72.2ROR 70.1 · calibrated p 1e-6 ✓	37.7 EB05 36.6 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.9 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Helicobacter infection	4,470	64.4 61.9–66.9ROR 65.5 · calibrated p 2e-6 ✓	36.2 EB05 35.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.2 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Sleep disorder due to general medical condition, insomnia type	2,774	62.4 59.4–65.5ROR 63.1 · calibrated p 3e-6 ✓	35.6 EB05 34.5 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2,769 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	857	60.9 55.7–66.6ROR 61.1 · calibrated p 4e-6 ✓	35.1 EB05 33.2 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=856 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Folliculitis	4,258	57.8 55.5–60.1ROR 58.7 · calibrated p 5e-6 ✓	34.0 EB05 33.2 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.4 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Pemphigus	4,971	54.8 52.9–56.8ROR 55.9 · calibrated p 7e-6 ✓	33.0 EB05 32.3 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.8 · ♀ 99% (drug 62%) · 93% clinician	no trial arm names this drug
X-ray abnormal	705	53.7 48.8–59.1ROR 53.9 · calibrated p 9e-6 ✓	32.6 EB05 30.6 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=705 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Hand deformity	5,080	52.2 50.4–54.1ROR 53.3 · calibrated p 9e-6 ✓	32.1 EB05 31.3 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0 · ♀ 100% (drug 62%) · 92% clinician	no trial arm names this drug
Subcutaneous drug absorption impaired	211	52.0 43.7–61.8ROR 52.0 · calibrated p 1e-5 ✓	31.9 EB05 28.4 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=204 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Dislocation of vertebra	853	51.1 46.9–55.7ROR 51.3 · calibrated p 1e-5 ✓	31.6 EB05 29.9 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=853 · ♀ 100% (drug 62%) · 94% clinician	no trial arm names this drug
Suspected suicide attempt	206	46.9 39.5–55.6ROR 46.9 · calibrated p 2e-5 ✓	29.9 EB05 26.6 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=206 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Analgesic drug level increased	585	46.6 42.1–51.6ROR 46.7 · calibrated p 2e-5 ✓	29.9 EB05 27.9 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=585 · 100% clinician	no trial arm names this drug
Anion gap	213	40.9 34.7–48.3ROR 41.0 · calibrated p 5e-5 ✓	27.4 EB05 24.5 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=212 · 100% clinician	no trial arm names this drug
Peripheral venous disease	1,266	38.1 35.6–40.7ROR 38.3 · calibrated p 7e-5 ✓	26.2 EB05 25.0 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1,265 · ♀ 100% (drug 62%) · 92% clinician	no trial arm names this drug
Retinitis	517	36.8 33.2–40.8ROR 36.9 · calibrated p 9e-5 ✓	25.6 EB05 23.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=517 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Synovitis	5,573	36.7 35.5–37.8ROR 37.5 · calibrated p 8e-5 ✓	25.5 EB05 24.9 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.6 · ♀ 98% (drug 62%) · 91% clinician	no trial arm names this drug
Pericarditis	5,041	35.6 34.4–36.8ROR 36.3 · calibrated p 9e-5 ✓	25.0 EB05 24.4 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.6 · ♀ 98% (drug 62%) · 93% clinician	no trial arm names this drug
C-reactive protein abnormal	1,839	33.0 31.3–34.9ROR 33.3 · calibrated p 2e-4 ✓	23.7 EB05 22.8 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=1,836 · ♀ 100% (drug 62%) · 93% clinician	no trial arm names this drug
Sedation complication	588	25.2 23.0–27.6ROR 25.2 · calibrated p 7e-4 ✓	19.4 EB05 18.1 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=585 · ♀ 100% (drug 62%)	no trial arm names this drug
Amaurosis fugax	250	25.0 21.7–28.8ROR 25.0 · calibrated p 7e-4 ✓	19.3 EB05 17.4 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=250 · 100% clinician	no trial arm names this drug
Seronegative arthritis	257	24.3 21.2–28.0ROR 24.3 · calibrated p 8e-4 ✓	18.9 EB05 17.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=257 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Infusion site discharge	385	23.8 21.2–26.7ROR 23.8 · calibrated p 9e-4 ✓	18.6 EB05 17.1 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=312 · 100% consumer	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	4,978	23.5 22.7–24.2ROR 23.9 · calibrated p 8e-4 ✓	18.4 EB05 18.0 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4 · ♀ 100% (drug 62%) · 92% clinician	no trial arm names this drug
Porphyria acute	288	21.6 18.9–24.6ROR 21.6 · calibrated p 0.001 ✓	17.2 EB05 15.6 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=287 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Liver injury	20,399	5.95.8–6.0	signal
Suicidality	13,610	4.84.7–4.9	signal
Severe cutaneous reaction	2,865	3.33.1–3.4	signal
Interstitial lung disease	3,322	2.92.8–3.0	signal
Serious infection	26,133	2.92.8–2.9	signal
Neutropenia / agranulocytosis	8,078	2.82.7–2.8	signal
Hyponatraemia	2,623	2.72.6–2.9	signal
Kidney injury	14,074	2.62.6–2.6	signal
Anaphylaxis / angioedema	3,735	2.52.4–2.6	signal
Anaemia	8,173	2.32.2–2.3	signal
Gi bleeding	4,783	2.22.1–2.3	signal
Thrombocytopenia	5,668	2.22.1–2.2	signal
Rhabdomyolysis / myopathy	2,061	2.12.0–2.2	signal
Pancreatitis	2,000	2.12.0–2.2	raised
Fall / fracture	9,275	2.02.0–2.1	raised
Opportunistic infection	3,173	1.91.9–2.0	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Acetaminophen 500Mg only as a background or rescue medication (NCT03472469, NCT01402375); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Off label use (used outside approved label)	23,028	2.2 2.2–2.3ROR 2.3 · calibrated p 0.881	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 1.9 · serious PRR 2.5	no trial arm names this drug
Fatigue (tiredness)	20,911	2.3 2.2–2.3ROR 2.4 · calibrated p 0.870	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.9 · serious PRR 2.5	no trial arm names this drug
Drug ineffective (drug did not work)	18,584	1.2 1.2–1.2ROR 1.2 · calibrated p 0.428	1.2 EB05 1.2 · IC025 +0.2	Reporting / coding artifact	age-adj. PRR 1.3 · serious PRR 2.0	no trial arm names this drug
Pain	18,474	2.5 2.5–2.6ROR 2.6 · calibrated p 0.753	2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.5 · serious PRR 2.4	no trial arm names this drug
Nausea	18,185	1.9 1.9–2.0ROR 2.0 · calibrated p 0.943	1.9 EB05 1.9 · IC025 +0.9	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.7 · serious PRR 2.1	no trial arm names this drug
Headache	17,143	2.3 2.3–2.3ROR 2.4 · calibrated p 0.860	2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.9 · serious PRR 2.6	no trial arm names this drug
Toxicity to various agents	15,844	8.5 8.4–8.7ROR 9.0 · calibrated p 0.045 ✓	7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 6.6 · serious PRR 5.1 · 96% clinician	no trial arm names this drug
Dyspnoea (shortness of breath)	15,027	2.2 2.2–2.3ROR 2.3 · calibrated p 0.900	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.8 · serious PRR 1.9	no trial arm names this drug
Pyrexia (fever)	14,580	3.6 3.5–3.6ROR 3.7 · calibrated p 0.428	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.8 · serious PRR 2.7	no trial arm names this drug
Arthralgia (joint pain)	14,572	3.0 2.9–3.0ROR 3.1 · calibrated p 0.596	2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.3 · serious PRR 3.3 · ♀ 85% (drug 62%)	no trial arm names this drug
Vomiting	14,484	2.6 2.6–2.6ROR 2.7 · calibrated p 0.732	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.3 · serious PRR 2.4	no trial arm names this drug
Diarrhoea (diarrhea)	13,729	1.8 1.8–1.8ROR 1.8 · calibrated p 0.845	1.8 EB05 1.7 · IC025 +0.8	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.6 · serious PRR 1.8	no trial arm names this drug
Rash	12,702	2.5 2.4–2.5ROR 2.5 · calibrated p 0.796	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.2 · serious PRR 3.2 · ♀ 82% (drug 62%)	no trial arm names this drug
Pneumonia (lung infection)	11,275	3.0 2.9–3.0ROR 3.0 · calibrated p 0.613	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.5 · serious PRR 2.0	no trial arm names this drug
Infusion related reaction (reaction during infusion)	11,209	16.7 16.4–17.1ROR 17.4 · calibrated p 0.004 ✓	14.0 EB05 13.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 12.8 · serious PRR 10.9 · ♀ 84% (drug 62%)	no trial arm names this drug

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: 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 500Mg?

In FDA FAERS, the most frequently co-reported reaction terms for Acetaminophen 500Mg are fatigue, pain, nausea, headache, toxicity to various agents, 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 500Mg have an FDA boxed warning?

No. The FDA label retrieved for Acetaminophen 500Mg has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Acetaminophen 500Mg 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 91acc132-01b6-467b-9af5-70f4dc93e087, effective 20190108; matched on openfda.generic_name.exact:"ACETAMINOPHEN 500MG")
PubChem CID 1983 description (ChEBI)
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, field patient.drug.openfda.generic_name.exact, 1,202 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
ClinicalTrials.gov API v2 (query ACETAMINOPHEN 500MG, results-bearing studies sorted by enrollment)

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.