Drug · FAERS side-effect profile with label screen

Ibuprofen and Liquid-Filled side effects: what 3,917 FDA adverse event reports show

Ibuprofen Capsule, Liquid-Filled · 149 reaction terms · 3,816 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

3,917 reports · 35% serious · 54 with death outcome · 70% 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 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 8Reporting / coding artifact 9Not in label — unassessed 21

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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. 109 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	252	46.6 41.3–52.5ROR 49.7 · χ² 11,109 / p <1e-300	46.0 EB05 41.4 · IC025 +5.2 3/3 methods agree	Labeled (related wording) related wording	serious n=2 · 99% consumer	no trial data cached
Oral discomfort	71	27.4 21.8–34.6ROR 27.9 · χ² 1,775 / p <1e-300	27.1 EB05 22.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=3 · 94% consumer	no trial data cached
Coeliac disease	47	25.7 19.4–34.2ROR 26.0 · χ² 1,089 / p 5e-239	25.4 EB05 19.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.4 · 98% consumer	no trial data cached
Poor quality product administered	41	21.6 15.9–29.2ROR 21.8 · χ² 780 / p 5e-172	21.3 EB05 16.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=3 · 100% consumer	no trial data cached
Product complaint	82	17.6 14.2–21.9ROR 18.0 · χ² 1,268 / p 5e-278	17.5 EB05 14.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=7 · 100% consumer	no trial data cached
Drug effect less than expected	37	14.1 10.2–19.4ROR 14.2 · χ² 436 / p 4e-97	13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Gallbladder disorder	44	13.2 9.8–17.7ROR 13.3 · χ² 483 / p 3e-107	12.9 EB05 9.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.4 · ♀ 95% (drug 70%)	no trial data cached
Cholelithiasis	79	12.9 10.4–16.1ROR 13.2 · χ² 856 / p 2e-188	12.8 EB05 10.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.6 · ♀ 99% (drug 70%)	no trial data cached
Hypoaesthesia oral	36	12.8 9.3–17.8ROR 12.9 · χ² 380 / p 6e-85	12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.4 · 89% consumer	no trial data cached
Cholecystitis	28	12.6 8.7–18.3ROR 12.7 · χ² 288 / p 6e-65	12.1 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 22.0 · ♀ 97% (drug 70%)	no trial data cached
Product taste abnormal	23	9.2 6.1–13.8ROR 9.2 · χ² 159 / p 9e-37	8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Product physical issue	34	9.1 6.5–12.8ROR 9.2 · χ² 238 / p 4e-54	8.5 EB05 6.2 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=4 · 100% consumer	no trial data cached
Product use complaint	25	8.6 5.8–12.8ROR 8.7 · χ² 161 / p 3e-37	7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=9 · 100% consumer	no trial data cached
Product use in unapproved indication	305	6.7 6.0–7.5ROR 7.2 · χ² 1,486 / p <1e-300	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 0.2 · 99% consumer	no trial data cached
Injection site haematoma	16	5.8 3.6–9.5ROR 5.9 · χ² 60 / p 6e-15	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Lip swelling	36	5.8 4.2–8.0ROR 5.8 · χ² 138 / p 3e-32	5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.4 · 94% consumer	no trial data cached
Throat irritation	46	5.5 4.1–7.3ROR 5.6 · χ² 166 / p 3e-38	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 96% consumer	no trial data cached
Fear	27	5.3 3.7–7.8ROR 5.4 · χ² 91 / p 8e-22	4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Retching	21	5.3 3.5–8.1ROR 5.3 · χ² 69 / p 5e-17	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · 86% consumer	no trial data cached
Deep vein thrombosis (leg blood clot)	64	5.2 4.1–6.7ROR 5.3 · χ² 216 / p 3e-49	5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.9 · ♀ 98% (drug 70%)	no trial data cached
Paraesthesia oral	14	5.2 3.1–8.8ROR 5.2 · χ² 44 / p 2e-11	4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.2	no trial data cached
Eye swelling	36	5.2 3.8–7.2ROR 5.3 · χ² 119 / p 6e-28	4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.6 · 97% consumer	no trial data cached
Cholecystectomy	11	5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9	4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Glossodynia (burning tongue/mouth pain)	21	5.0 3.3–7.7ROR 5.1 · χ² 64 / p 7e-16	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.3 · ♀ 90% (drug 70%)	no trial data cached
Ulcer	14	4.7 2.8–7.9ROR 4.7 · χ² 37 / p 5e-10	4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 3.5	no trial data cached
Faeces discoloured	19	4.7 3.0–7.4ROR 4.7 · χ² 52 / p 3e-13	4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 1.2	no trial data cached
Gastric haemorrhage	10	4.6 2.5–8.6ROR 4.6 · χ² 25 / p 3e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.0	no trial data cached
Renal failure acute	36	4.5 3.2–6.2ROR 4.5 · χ² 94 / p 2e-22	4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.5 · ♀ 47% (drug 70%) · 91% clinician	no trial data cached
Drug administration error	26	4.5 3.1–6.6ROR 4.5 · χ² 67 / p 2e-16	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7 · 100% consumer	no trial data cached
Expired product administered	26	4.2 2.9–6.2ROR 4.2 · χ² 60 / p 4e-15	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious n=3 · 100% consumer	no trial data cached
Choking	15	4.1 2.5–6.9ROR 4.1 · χ² 33 / p 6e-9	3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Hiatus hernia	10	4.1 2.2–7.7ROR 4.1 · χ² 21 / p 3e-6	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Abdominal pain upper	154	4.0 3.4–4.7ROR 4.1 · χ² 349 / p 4e-78	4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.2 · 77% consumer	no trial data cached
Pulmonary embolism (lung blood clot)	71	4.0 3.2–5.0ROR 4.0 · χ² 156 / p 4e-36	3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · ♀ 96% (drug 70%)	no trial data cached
Injury	52	3.9 3.0–5.2ROR 4.0 · χ² 112 / p 2e-26	3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.1	no trial data cached
Abnormal dreams	20	3.9 2.5–6.0ROR 3.9 · χ² 39 / p 2e-10	3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Drug effect decreased	39	3.8 2.8–5.2ROR 3.9 · χ² 79 / p 4e-19	3.7 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.8 · 95% consumer	no trial data cached
Pharyngeal oedema	11	3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Irritable bowel syndrome	15	3.8 2.3–6.2ROR 3.8 · χ² 28 / p 7e-8	3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Multi-organ failure	12	3.7 2.1–6.4ROR 3.7 · χ² 21 / p 3e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	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	305	6.7 6.0–7.5ROR 7.2 · χ² 1,486 / p <1e-300	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 0.2 · 99% consumer	no trial data cached
Drug effective for unapproved indication	252	46.6 41.3–52.5ROR 49.7 · χ² 11,109 / p <1e-300	46.0 EB05 41.4 · IC025 +5.2 3/3 methods agree	Labeled (related wording) related wording	serious n=2 · 99% consumer	no trial data cached
Abdominal pain upper	154	4.0 3.4–4.7ROR 4.1 · χ² 349 / p 4e-78	4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.2 · 77% consumer	no trial data cached
Abdominal discomfort	94	3.0 2.5–3.7ROR 3.1 · χ² 125 / p 2e-29	3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 1.8 · 92% consumer	no trial data cached
Incorrect dose administered	93	2.2 1.8–2.7ROR 2.2 · χ² 61 / p 2e-15	2.2 EB05 1.9 · IC025 +0.8	Reporting / coding artifact	serious PRR 1.0 · 93% consumer	no trial data cached
Overdose	82	2.0 1.6–2.5ROR 2.0 · χ² 42 / p 4e-11	2.0 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.7 · 77% consumer	no trial data cached
Product complaint	82	17.6 14.2–21.9ROR 18.0 · χ² 1,268 / p 5e-278	17.5 EB05 14.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=7 · 100% consumer	no trial data cached
Cholelithiasis	79	12.9 10.4–16.1ROR 13.2 · χ² 856 / p 2e-188	12.8 EB05 10.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.6 · ♀ 99% (drug 70%)	no trial data cached
Urticaria (hives)	72	2.3 1.8–2.9ROR 2.3 · χ² 53 / p 2e-13	2.3 EB05 1.9 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 3.2 · 80% consumer	no trial data cached
Pulmonary embolism (lung blood clot)	71	4.0 3.2–5.0ROR 4.0 · χ² 156 / p 4e-36	3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · ♀ 96% (drug 70%)	no trial data cached
Oral discomfort	71	27.4 21.8–34.6ROR 27.9 · χ² 1,775 / p <1e-300	27.1 EB05 22.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=3 · 94% consumer	no trial data cached
Paraesthesia (tingling/numbness)	68	2.3 1.8–2.9ROR 2.3 · χ² 50 / p 1e-12	2.3 EB05 1.9 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 3.5	no trial data cached
Deep vein thrombosis (leg blood clot)	64	5.2 4.1–6.7ROR 5.3 · χ² 216 / p 3e-49	5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.9 · ♀ 98% (drug 70%)	no trial data cached
Dyspepsia (indigestion)	58	3.2 2.5–4.1ROR 3.2 · χ² 84 / p 2e-20	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.8 · 84% consumer	no trial data cached
Flushing	55	2.9 2.2–3.7ROR 2.9 · χ² 66 / p 2e-16	2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 1.6 · ♀ 46% (drug 70%) · 93% consumer	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.

Oral discomfort — n=71, PRR 27.4
Coeliac disease — n=47, PRR 25.7
Poor quality product administered — n=41, PRR 21.6
Gallbladder disorder — n=44, PRR 13.2
Cholelithiasis — n=79, PRR 12.9
Hypoaesthesia oral — n=36, PRR 12.8
Cholecystitis — n=28, PRR 12.6
Throat irritation — n=46, PRR 5.5
Fear — n=27, PRR 5.3
Retching — n=21, PRR 5.3

✓ 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 Liquid-Filled?

In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen and Liquid-Filled are drug effective for unapproved indication, abdominal pain upper, abdominal discomfort, cholelithiasis, urticaria, pulmonary embolism. 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 Liquid-Filled 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 Liquid-Filled 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, 149 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.