Drug · FAERS side-effect profile with label screen

Ibuprofen Acetaminophen Tablet Film Coated side effects: what 2,216 FDA adverse event reports show

Ibuprofen, Acetaminophen Tablet, Film Coated · 10 reaction terms · 2,886 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Ibuprofen (Ibuprofen)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

2,216 reports · 2% serious · 2 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

FDA label, Indications and Usage

What it is

DESCRIPTION Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with a.

FDA label, Description section

Boxed warning

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ].

FDA 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 9 strongest signals

Labeled (related wording) 2Reporting / coding artifact 7

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 1 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
Drug effective for unapproved indication	1,176	396.6 380.7–413.2ROR 843.2 · χ² 445,411 / p <1e-300	378.2 EB05 360.4 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 100% consumer	no trial data cached
Drug effect less than expected	118	79.8 66.9–95.2ROR 84.2 · χ² 9,031 / p <1e-300	78.2 EB05 67.0 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Product use in unapproved indication	1,292	50.3 48.5–52.1ROR 119.0 · χ² 62,731 / p <1e-300	50.0 EB05 47.7 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · 100% consumer	no trial data cached
Therapeutic response unexpected	71	14.9 11.9–18.8ROR 15.4 · χ² 909 / p 4e-200	14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	99% consumer	no trial data cached
Therapeutic product effect incomplete	110	14.7 12.3–17.7ROR 15.4 · χ² 1,396 / p <1e-300	14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Drug ineffective for unapproved indication	73	12.4 9.9–15.5ROR 12.8 · χ² 754 / p 2e-166	12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Product complaint	15	5.7 3.4–9.4ROR 5.7 · χ² 53 / p 1e-13	4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Contraindicated product administered	16	5.0 3.1–8.2ROR 5.0 · χ² 48 / p 3e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.9	no trial data cached
Circumstance or information capable of leading to medication error	11	3.1 1.7–5.6ROR 3.1 · χ² 14 / p 1e-4	2.8 EB05 1.7 · IC025 +0.5	Labeled (related wording) related wording	–	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
Product use in unapproved indication	1,292	50.3 48.5–52.1ROR 119.0 · χ² 62,731 / p <1e-300	50.0 EB05 47.7 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · 100% consumer	no trial data cached
Drug effective for unapproved indication	1,176	396.6 380.7–413.2ROR 843.2 · χ² 445,411 / p <1e-300	378.2 EB05 360.4 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 100% consumer	no trial data cached
Drug effect less than expected	118	79.8 66.9–95.2ROR 84.2 · χ² 9,031 / p <1e-300	78.2 EB05 67.0 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Therapeutic product effect incomplete	110	14.7 12.3–17.7ROR 15.4 · χ² 1,396 / p <1e-300	14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Drug ineffective for unapproved indication	73	12.4 9.9–15.5ROR 12.8 · χ² 754 / p 2e-166	12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Therapeutic response unexpected	71	14.9 11.9–18.8ROR 15.4 · χ² 909 / p 4e-200	14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	99% consumer	no trial data cached
Contraindicated product administered	16	5.0 3.1–8.2ROR 5.0 · χ² 48 / p 3e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.9	no trial data cached
Product complaint	15	5.7 3.4–9.4ROR 5.7 · χ² 53 / p 1e-13	4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Circumstance or information capable of leading to medication error	11	3.1 1.7–5.6ROR 3.1 · χ² 14 / p 1e-4	2.8 EB05 1.7 · IC025 +0.5	Labeled (related wording) related wording	–	no trial data cached
Product administered at inappropriate site	4	2.1 0.8–5.5ROR 2.1 · χ² 1 / p 0.127	1.9 EB05 0.9 · IC025 -0.9 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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: Ibuprofen (NSAIDs) ↔ Gastrointestinal bleeding.

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 Ibuprofen and Acetaminophen?

In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen and Acetaminophen are drug effective for unapproved indication, circumstance or information capable of leading to medication error. 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 Ibuprofen and Acetaminophen have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ].

Do FAERS signals prove that Ibuprofen and 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 00872852-680a-41b3-901b-b991b12a176d, effective 20250214; matched on openfda.generic_name.exact:"IBUPROFEN")
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, 10 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.