Flurbiprofen side effects: what 1,511 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
1,511 reports · 88% serious · 185 with death outcome · 65% female
Used for
Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of rheumatoid arthritis ( 1 ) Relief of the signs and symptoms of osteoarthritis ( 1 )
What it is
Flurbiprofen Tablets, USP are a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drug. Flurbiprofen Tablets, USP are round, blue, film-coated debossed "NH" – "100" tablets for oral administration. Flurbiprofen, USP is a racemic mixture of (+)S- and (-)R- enantiomers.
Boxed warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammato.
Causality screen of the 38 strongest signals
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.
- 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. 34 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 |
|---|---|---|---|---|---|---|
| Angioedema (deep swelling of face/throat) | 89 | 28.1 22.9–34.3ROR 29.8 · χ² 2,297 / p <1e-300 | 27.9 EB05 23.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.3 · 95% clinician | no trial data cached |
| Ankylosing spondylitis | 26 | 27.8 19.0–40.7ROR 28.2 · χ² 644 / p 3e-142 | 27.2 EB05 19.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| Sudden death | 16 | 20.8 12.8–33.9ROR 21.0 · χ² 282 / p 1e-63 | 20.2 EB05 13.0 · IC025 +2.9 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 13.6 | no trial data cached |
| Eyelid oedema | 17 | 20.2 12.6–32.4ROR 20.4 · χ² 291 / p 1e-65 | 19.7 EB05 12.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 | no trial data cached |
| Poisoning deliberate | 13 | 19.4 11.3–33.4ROR 19.6 · χ² 209 / p 1e-47 | 18.6 EB05 11.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 35 | 19.1 13.7–26.4ROR 19.5 · χ² 581 / p 1e-128 | 18.8 EB05 14.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · ♀ 93% (drug 65%) · 100% clinician | no trial data cached |
| Spinal pain | 16 | 19.0 11.7–31.0ROR 19.2 · χ² 255 / p 1e-57 | 18.4 EB05 11.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Ileus | 11 | 12.4 6.9–22.4ROR 12.5 · χ² 104 / p 8e-25 | 10.6 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Hepatic cytolysis | 10 | 11.4 6.1–21.1ROR 11.4 · χ² 85 / p 2e-20 | 9.3 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Uveitis | 11 | 11.3 6.3–20.4ROR 11.4 · χ² 93 / p 2e-22 | 9.4 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Toothache | 14 | 10.8 6.4–18.1ROR 10.9 · χ² 114 / p 5e-27 | 9.3 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 14 | 10.5 6.3–17.7ROR 10.6 · χ² 111 / p 2e-26 | 9.0 EB05 5.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Drug eruption | 13 | 10.3 6.0–17.6ROR 10.3 · χ² 100 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Disseminated intravascular coagulation | 10 | 9.8 5.3–18.3ROR 9.9 · χ² 71 / p 2e-17 | 7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Abnormal dreams | 17 | 8.5 5.3–13.6ROR 8.6 · χ² 105 / p 5e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Inflammation | 31 | 8.4 5.9–11.9ROR 8.6 · χ² 195 / p 1e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 92% clinician | no trial data cached |
| Contraindicated product administered | 17 | 7.8 4.9–12.6ROR 7.9 · χ² 95 / p 1e-22 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Respiratory tract infection | 14 | 7.5 4.4–12.6ROR 7.6 · χ² 72 / p 8e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Renal failure acute | 23 | 7.4 5.0–11.1ROR 7.5 · χ² 122 / p 1e-28 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 95% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 19 | 7.3 4.7–11.5ROR 7.4 · χ² 98 / p 2e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Post procedural complication | 10 | 7.2 3.9–13.4ROR 7.3 · χ² 48 / p 3e-12 | 5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Musculoskeletal stiffness | 45 | 7.1 5.4–9.5ROR 7.3 · χ² 232 / p 1e-52 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Altered state of consciousness | 11 | 7.1 3.9–12.8ROR 7.1 · χ² 52 / p 3e-13 | 5.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Multiple organ dysfunction syndrome | 14 | 7.0 4.1–11.7ROR 7.0 · χ² 66 / p 2e-16 | 5.8 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 26 | 6.6 4.5–9.6ROR 6.7 · χ² 118 / p 1e-27 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.4 · 96% clinician | no trial data cached |
| Anaphylactic shock | 12 | 6.5 3.7–11.4ROR 6.6 · χ² 51 / p 6e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Hepatic failure | 14 | 6.4 3.8–10.8ROR 6.5 · χ² 59 / p 8e-15 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Arrhythmia | 21 | 6.1 4.0–9.4ROR 6.2 · χ² 85 / p 1e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 10% (drug 65%) | no trial data cached |
| Eye disorder | 14 | 5.9 3.5–10.0ROR 6.0 · χ² 53 / p 2e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Urticaria (hives) | 70 | 5.8 4.7–7.4ROR 6.1 · χ² 279 / p 8e-63 | 5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 95% clinician | no trial data cached |
| Localised infection | 10 | 5.7 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9 | 4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Intentional overdose | 26 | 5.7 3.9–8.3ROR 5.8 · χ² 96 / p 7e-23 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 35% (drug 65%) · 92% clinician | no trial data cached |
| Abortion spontaneous | 14 | 4.8 2.9–8.1ROR 4.9 · χ² 39 / p 2e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Exposure during pregnancy | 20 | 4.5 2.9–6.9ROR 4.5 · χ² 51 / p 6e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 95% clinician | no trial data cached |
| Maternal exposure during pregnancy | 26 | 4.1 2.8–6.0ROR 4.2 · χ² 58 / p 1e-14 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Drug exposure during pregnancy | 10 | 4.0 2.2–7.5ROR 4.0 · χ² 20 / p 4e-6 | 3.5 EB05 2.1 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Toxicity to various agents | 48 | 4.0 3.0–5.3ROR 4.1 · χ² 105 / p 7e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 96% clinician | no trial data cached |
| Suicide attempt | 15 | 3.4 2.1–5.7ROR 3.5 · χ² 24 / p 6e-7 | 3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | 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 |
|---|---|---|---|---|---|---|
| Angioedema (deep swelling of face/throat) | 89 | 28.1 22.9–34.3ROR 29.8 · χ² 2,297 / p <1e-300 | 27.9 EB05 23.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.3 · 95% clinician | no trial data cached |
| Urticaria (hives) | 70 | 5.8 4.7–7.4ROR 6.1 · χ² 279 / p 8e-63 | 5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 95% clinician | no trial data cached |
| Toxicity to various agents | 48 | 4.0 3.0–5.3ROR 4.1 · χ² 105 / p 7e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 96% clinician | no trial data cached |
| Musculoskeletal stiffness | 45 | 7.1 5.4–9.5ROR 7.3 · χ² 232 / p 1e-52 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 35 | 19.1 13.7–26.4ROR 19.5 · χ² 581 / p 1e-128 | 18.8 EB05 14.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · ♀ 93% (drug 65%) · 100% clinician | no trial data cached |
| Inflammation | 31 | 8.4 5.9–11.9ROR 8.6 · χ² 195 / p 1e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 92% clinician | no trial data cached |
| Maternal exposure during pregnancy | 26 | 4.1 2.8–6.0ROR 4.2 · χ² 58 / p 1e-14 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Intentional overdose | 26 | 5.7 3.9–8.3ROR 5.8 · χ² 96 / p 7e-23 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 35% (drug 65%) · 92% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 26 | 6.6 4.5–9.6ROR 6.7 · χ² 118 / p 1e-27 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.4 · 96% clinician | no trial data cached |
| Ankylosing spondylitis | 26 | 27.8 19.0–40.7ROR 28.2 · χ² 644 / p 3e-142 | 27.2 EB05 19.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| Renal failure acute | 23 | 7.4 5.0–11.1ROR 7.5 · χ² 122 / p 1e-28 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 95% clinician | no trial data cached |
| Arrhythmia | 21 | 6.1 4.0–9.4ROR 6.2 · χ² 85 / p 1e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 10% (drug 65%) | no trial data cached |
| Exposure during pregnancy | 20 | 4.5 2.9–6.9ROR 4.5 · χ² 51 / p 6e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 95% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 19 | 7.3 4.7–11.5ROR 7.4 · χ² 98 / p 2e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Contraindicated product administered | 17 | 7.8 4.9–12.6ROR 7.9 · χ² 95 / p 1e-22 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | 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.
- Ankylosing spondylitis — n=26, PRR 27.8
- Musculoskeletal stiffness — n=45, PRR 7.1
- Toxicity to various agents — n=48, PRR 4.0
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 Flurbiprofen?
In FDA FAERS, the most frequently co-reported reaction terms for Flurbiprofen are angioedema, urticaria, toxicity to various agents, musculoskeletal stiffness, drug reaction with eosinophilia and systemic symptoms, inflammation. 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 Flurbiprofen have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammato.
Do FAERS signals prove that Flurbiprofen 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 4670cf21-eb0e-4f5a-ab22-41af85733525, effective 20260203; matched on
openfda.generic_name.exact:"FLURBIPROFEN") - 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, 72 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.