Ibuprofen Tablets side effects: what 1,414 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
1,414 reports · 84% serious · 164 with death outcome · 58% female
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.
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.
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 ].
Causality screen of the 18 strongest signals
What the badges mean
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 31 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 |
|---|---|---|---|---|---|---|
| Renal failure acute | 56 | 19.3 15.0–25.0ROR 20.1 · χ² 957 / p 2e-210 | 19.2 EB05 15.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 · 100% clinician | no trial data cached |
| Drug toxicity | 16 | 17.2 10.6–28.0ROR 17.4 · χ² 228 / p 7e-52 | 16.6 EB05 10.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 | no trial data cached |
| Gastric haemorrhage | 12 | 15.4 8.8–27.1ROR 15.5 · χ² 147 / p 3e-34 | 14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Haematemesis (vomiting blood) | 23 | 13.4 9.0–20.2ROR 13.7 · χ² 253 / p 3e-57 | 12.9 EB05 8.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Melaena (black stool) | 19 | 12.8 8.2–20.0ROR 13.0 · χ² 195 / p 1e-44 | 12.0 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Respiratory depression | 10 | 12.1 6.5–22.5ROR 12.2 · χ² 91 / p 7e-22 | 10.1 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Hepatic steatosis | 13 | 10.4 6.0–17.8ROR 10.5 · χ² 101 / p 4e-24 | 8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Gastritis | 18 | 10.2 6.4–16.1ROR 10.3 · χ² 140 / p 1e-32 | 9.0 EB05 5.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Gastric ulcer | 13 | 10.1 5.9–17.4ROR 10.2 · χ² 98 / p 2e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 10 | 9.9 5.3–18.3ROR 9.9 · χ² 71 / p 2e-17 | 7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Metabolic acidosis | 17 | 8.0 5.0–12.8ROR 8.1 · χ² 97 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Flushing | 42 | 6.1 4.5–8.2ROR 6.3 · χ² 175 / p 3e-40 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 0.5 | no trial data cached |
| Suicide attempt | 24 | 5.9 3.9–8.7ROR 6.0 · χ² 92 / p 4e-22 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 91% clinician | no trial data cached |
| Gastrointestinal haemorrhage | 32 | 5.7 4.0–8.0ROR 5.8 · χ² 118 / p 7e-28 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Coma | 18 | 5.6 3.5–8.9ROR 5.7 · χ² 64 / p 7e-16 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Convulsion (seizure) | 20 | 5.1 3.3–7.9ROR 5.2 · χ² 62 / p 1e-15 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 90% (drug 58%) | no trial data cached |
| Intentional overdose | 20 | 4.7 3.0–7.2ROR 4.7 · χ² 54 / p 1e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Completed suicide (death by suicide) | 23 | 4.1 2.7–6.1ROR 4.1 · χ² 50 / p 7e-13 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.8 · 100% 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 |
|---|---|---|---|---|---|---|
| Renal failure acute | 56 | 19.3 15.0–25.0ROR 20.1 · χ² 957 / p 2e-210 | 19.2 EB05 15.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 · 100% clinician | no trial data cached |
| Flushing | 42 | 6.1 4.5–8.2ROR 6.3 · χ² 175 / p 3e-40 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 0.5 | no trial data cached |
| Gastrointestinal haemorrhage | 32 | 5.7 4.0–8.0ROR 5.8 · χ² 118 / p 7e-28 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Suicide attempt | 24 | 5.9 3.9–8.7ROR 6.0 · χ² 92 / p 4e-22 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 91% clinician | no trial data cached |
| Completed suicide (death by suicide) | 23 | 4.1 2.7–6.1ROR 4.1 · χ² 50 / p 7e-13 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.8 · 100% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 23 | 13.4 9.0–20.2ROR 13.7 · χ² 253 / p 3e-57 | 12.9 EB05 8.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Intentional overdose | 20 | 4.7 3.0–7.2ROR 4.7 · χ² 54 / p 1e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Convulsion (seizure) | 20 | 5.1 3.3–7.9ROR 5.2 · χ² 62 / p 1e-15 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 90% (drug 58%) | no trial data cached |
| Melaena (black stool) | 19 | 12.8 8.2–20.0ROR 13.0 · χ² 195 / p 1e-44 | 12.0 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Coma | 18 | 5.6 3.5–8.9ROR 5.7 · χ² 64 / p 7e-16 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Gastritis | 18 | 10.2 6.4–16.1ROR 10.3 · χ² 140 / p 1e-32 | 9.0 EB05 5.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Metabolic acidosis | 17 | 8.0 5.0–12.8ROR 8.1 · χ² 97 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Drug toxicity | 16 | 17.2 10.6–28.0ROR 17.4 · χ² 228 / p 7e-52 | 16.6 EB05 10.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 | no trial data cached |
| Gastric ulcer | 13 | 10.1 5.9–17.4ROR 10.2 · χ² 98 / p 2e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Hepatic steatosis | 13 | 10.4 6.0–17.8ROR 10.5 · χ² 101 / p 4e-24 | 8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | 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.
- Haematemesis — n=23, PRR 13.4
- Flushing — n=42, PRR 6.1
- Suicide attempt — n=24, PRR 5.9
- Convulsion — n=20, PRR 5.1
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen are renal failure acute, flushing, gastrointestinal haemorrhage, suicide attempt, haematemesis, convulsion. 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 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 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, fieldpatient.drug.openfda.generic_name.exact, 49 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.