Ketoprofen side effects: what 13,012 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
13,012 reports · 86% serious · 1,182 with death outcome · 64% female
Used for
Carefully consider the potential benefits and risks of Ketoprofen Capsules USP and other treatment options before deciding to use Ketoprofen Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen Capsules, USP is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
What it is
DESCRIPTION Ketoprofen is a non-steroidal anti-inflammatory drug.
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 40 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 1,109 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 |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 26 | 1,084.8 658.9–1,786.0ROR 1,087.0 · χ² 16,078 / p <1e-300 | 436.6 EB05 313.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 64%) | not reported in cached trials |
| Epidural analgesia | 10 | 720.7 341.3–1,521.6ROR 721.2 · χ² 4,458 / p <1e-300 | 254.8 EB05 147.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Procedure aborted | 10 | 660.6 316.0–1,381.2ROR 661.1 · χ² 4,195 / p <1e-300 | 246.9 EB05 143.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Device wireless communication issue | 64 | 554.5 417.4–736.7ROR 557.2 · χ² 25,789 / p <1e-300 | 366.0 EB05 296.7 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=22 · 91% consumer | not reported in cached trials |
| Polyneuropathy in malignant disease | 18 | 453.0 268.4–764.7ROR 453.6 · χ² 5,967 / p <1e-300 | 256.6 EB05 171.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Temperature regulation disorder | 465 | 435.7 393.8–482.1ROR 451.8 · χ² 157,882 / p <1e-300 | 337.3 EB05 312.3 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=465 · ♀ 100% (drug 64%) | not reported in cached trials |
| Spinal epidural haemorrhage | 16 | 402.7 232.7–696.8ROR 403.2 · χ² 4,797 / p <1e-300 | 232.4 EB05 151.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Encephalitis bacterial | 10 | 396.4 198.3–792.4ROR 396.7 · χ² 2,846 / p <1e-300 | 198.0 EB05 114.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Product administration issue | 14 | 352.3 197.5–628.6ROR 352.7 · χ² 3,730 / p <1e-300 | 207.3 EB05 131.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=14 | not reported in cached trials |
| Diffuse axonal injury | 12 | 333.8 179.2–621.9ROR 334.1 · χ² 3,020 / p <1e-300 | 192.1 EB05 117.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Device maintenance issue | 94 | 321.9 258.1–401.5ROR 324.2 · χ² 24,730 / p <1e-300 | 253.9 EB05 213.7 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=34 · 94% consumer | not reported in cached trials |
| Allergy test negative | 23 | 278.4 178.8–433.4ROR 278.9 · χ² 5,174 / p <1e-300 | 198.2 EB05 139.1 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=23 · 100% clinician | not reported in cached trials |
| Infusion site injury | 23 | 255.0 164.2–396.0ROR 255.5 · χ² 4,797 / p <1e-300 | 186.1 EB05 130.6 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 · 100% consumer | NCT04802967: 1/12 (8.3%) on Ketoprofen |
| Epidural haemorrhage | 13 | 180.8 101.9–320.8ROR 181.0 · χ² 1,928 / p <1e-300 | 131.5 EB05 81.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Infusion site discharge | 140 | 143.4 120.7–170.3ROR 144.9 · χ² 18,025 / p <1e-300 | 129.3 EB05 112.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=39 · 95% consumer | not reported in cached trials |
| Infusion site scab | 10 | 142.8 74.8–272.8ROR 142.9 · χ² 1,165 / p 1e-255 | 105.4 EB05 61.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Infusion site irritation | 98 | 137.6 112.0–169.1ROR 138.7 · χ² 12,106 / p <1e-300 | 123.7 EB05 104.5 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 90% consumer | NCT04802967: 1/16 (6.2%) on Ketoprofen |
| Infusion site induration | 112 | 137.5 113.5–166.7ROR 138.7 · χ² 13,846 / p <1e-300 | 124.0 EB05 105.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% consumer | not reported in cached trials |
| Confusion postoperative | 10 | 132.1 69.3–251.8ROR 132.2 · χ² 1,083 / p 8e-238 | 99.5 EB05 57.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Heterophoria | 11 | 131.1 70.9–242.5ROR 131.2 · χ² 1,195 / p 5e-262 | 100.6 EB05 59.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Food allergy | 567 | 130.5 120.0–141.9ROR 136.4 · χ² 67,225 / p <1e-300 | 120.2 EB05 112.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=566 · ♀ 100% (drug 64%) | not reported in cached trials |
| Infusion site inflammation | 46 | 117.6 87.2–158.6ROR 118.0 · χ² 4,844 / p <1e-300 | 104.9 EB05 81.8 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=13 · 100% consumer | not reported in cached trials |
| Infusion site haemorrhage | 220 | 117.1 102.2–134.1ROR 119.1 · χ² 23,476 / p <1e-300 | 108.1 EB05 96.6 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=56 · 96% consumer | not reported in cached trials |
| Infusion site warmth | 81 | 116.1 92.7–145.4ROR 116.8 · χ² 8,507 / p <1e-300 | 105.6 EB05 87.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% consumer | not reported in cached trials |
| Infusion site infection | 151 | 114.8 97.4–135.3ROR 116.1 · χ² 15,776 / p <1e-300 | 105.7 EB05 92.3 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=65 · 88% consumer | NCT00553605: 1/174 (0.6%) on Ketoprofen (serious AE) |
| Infusion site nodule | 59 | 112.7 86.6–146.7ROR 113.2 · χ² 5,995 / p <1e-300 | 101.9 EB05 81.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=15 · 100% consumer | not reported in cached trials |
| Infusion site discolouration | 56 | 111.8 85.3–146.6ROR 112.3 · χ² 5,643 / p <1e-300 | 101.0 EB05 80.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=12 · 100% consumer | not reported in cached trials |
| Infusion site pain | 764 | 102.3 95.3–109.9ROR 108.6 · χ² 71,951 / p <1e-300 | 95.9 EB05 90.4 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=198 · 95% consumer | NCT00553605: 1/174 (0.6%) on Ketoprofen (serious AE) |
| Patient dissatisfaction with device | 14 | 100.4 58.5–172.3ROR 100.5 · χ² 1,204 / p 4e-264 | 84.0 EB05 53.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Infusion site erythema | 477 | 98.2 89.6–107.5ROR 101.8 · χ² 43,122 / p <1e-300 | 92.2 EB05 85.4 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=126 · 95% consumer | NCT04802967: 1/16 (6.2%) on Ketoprofen |
| Infusion site swelling | 328 | 90.5 81.0–101.0ROR 92.8 · χ² 27,375 / p <1e-300 | 85.2 EB05 77.8 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=80 · 95% consumer | not reported in cached trials |
| Postoperative delirium | 10 | 90.1 47.6–170.3ROR 90.2 · χ² 751 / p 1e-165 | 73.8 EB05 42.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Foetal death | 266 | 86.9 76.9–98.2ROR 88.7 · χ² 21,346 / p <1e-300 | 82.0 EB05 74.1 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=266 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Device infusion issue | 123 | 85.0 70.9–101.8ROR 85.8 · χ² 9,610 / p <1e-300 | 79.7 EB05 68.6 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=37 · 93% consumer | not reported in cached trials |
| Infusion site cellulitis | 23 | 76.6 50.4–116.4ROR 76.7 · χ² 1,566 / p <1e-300 | 69.1 EB05 48.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Central pain syndrome | 12 | 76.1 42.7–135.8ROR 76.2 · χ² 778 / p 1e-171 | 65.4 EB05 39.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Coeliac disease | 428 | 73.3 66.6–80.6ROR 75.7 · χ² 29,111 / p <1e-300 | 69.9 EB05 64.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 58.3 · ♀ 100% (drug 64%) | not reported in cached trials |
| Migraine without aura | 13 | 73.1 41.9–127.4ROR 73.2 · χ² 816 / p 9e-180 | 63.7 EB05 39.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Renal cortical necrosis | 10 | 73.1 38.8–137.7ROR 73.1 · χ² 612 / p 2e-135 | 62.0 EB05 36.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Nsaid exacerbated respiratory disease | 15 | 71.0 42.3–119.1ROR 71.1 · χ² 925 / p 2e-203 | 62.8 EB05 40.4 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ketoprofen as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).
- NCT00553605 — Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic (N=340, PHASE4; 40 AE terms posted; arms: Parecoxib; Ketoprofen)
- NCT04802967 — A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Hea (N=141, PHASE1; 24 AE terms posted; arms: KLS 80 mg (PART A); KLS 80 Mg and GABA 34 mg (PART A); KLS 40 mg (Part B); KLS 80 mg (Part B))
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Headache | 1,232 | 3.2 3.0–3.3ROR 3.4 · χ² 1,878 / p <1e-300 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · ♀ 88% (drug 64%) | NCT00553605: 4/164 (2.4%) on Ketoprofen |
| Pain | 1,138 | 3.0 2.8–3.1ROR 3.2 · χ² 1,535 / p <1e-300 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.8 · ♀ 86% (drug 64%) | NCT00553605: 1/174 (0.6%) on Ketoprofen (serious AE) |
| Fatigue (tiredness) | 931 | 1.9 1.8–2.1ROR 2.0 · χ² 430 / p 7e-96 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 · ♀ 87% (drug 64%) | NCT04802967: 2/16 (12.5%) on Ketoprofen |
| Nausea | 801 | 1.6 1.5–1.7ROR 1.7 · χ² 203 / p 2e-46 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00553605: 5/164 (3.0%) on Ketoprofen |
| Drug ineffective (drug did not work) | 773 | 0.9 0.9–1.0ROR 0.9 · χ² 3 / p 0.050 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Off label use (used outside approved label) | 767 | 1.4 1.3–1.5ROR 1.4 · χ² 99 / p 1e-23 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.7 · ♀ 85% (drug 64%) | not reported in cached trials |
| Infusion site pain | 764 | 102.3 95.3–109.9ROR 108.6 · χ² 71,951 / p <1e-300 | 95.9 EB05 90.4 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=198 · 95% consumer | NCT00553605: 1/174 (0.6%) on Ketoprofen (serious AE) |
| Pyrexia (fever) | 757 | 3.5 3.3–3.8ROR 3.7 · χ² 1,384 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.9 | NCT00553605: 1/164 (0.6%) on Ketoprofen |
| Hypersensitivity (allergic reaction) | 705 | 6.1 5.7–6.6ROR 6.4 · χ² 3,040 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · ♀ 94% (drug 64%) | not reported in cached trials |
| Rheumatoid arthritis | 697 | 10.0 9.3–10.7ROR 10.5 · χ² 5,608 / p <1e-300 | 9.9 EB05 9.3 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.0 · ♀ 97% (drug 64%) | not reported in cached trials |
| Hyperhidrosis (excessive sweating) | 693 | 8.7 8.1–9.3ROR 9.1 · χ² 4,706 / p <1e-300 | 8.6 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 91% (drug 64%) | not reported in cached trials |
| Back pain | 690 | 4.8 4.4–5.1ROR 5.0 · χ² 2,078 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · ♀ 85% (drug 64%) | NCT00553605: 3/164 (1.8%) on Ketoprofen |
| Diarrhoea (diarrhea) | 685 | 1.7 1.6–1.8ROR 1.8 · χ² 209 / p 1e-47 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00553605: 1/174 (0.6%) on Ketoprofen |
| Rash | 667 | 2.5 2.3–2.7ROR 2.6 · χ² 596 / p 5e-132 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 85% (drug 64%) | NCT04802967: 1/16 (6.2%) on Ketoprofen |
| Erythema (skin redness) | 655 | 5.1 4.8–5.5ROR 5.4 · χ² 2,196 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · ♀ 86% (drug 64%) | NCT04802967: 1/16 (6.2%) on Ketoprofen |
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.
- Amyloid arthropathy — n=26, PRR 1,084.8
- Temperature regulation disorder — n=465, PRR 435.7
- Infusion site discharge — n=140, PRR 143.4
- Infusion site induration — n=112, PRR 137.5
- Food allergy — n=567, PRR 130.5
- Infusion site warmth — n=81, PRR 116.1
- Infusion site nodule — n=59, PRR 112.7
- Infusion site discolouration — n=56, PRR 111.8
- Infusion site cellulitis — n=23, PRR 76.6
- Coeliac disease — n=428, PRR 73.3
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 Ketoprofen?
In FDA FAERS, the most frequently co-reported reaction terms for Ketoprofen are headache, pain, fatigue, nausea, infusion site pain, pyrexia. 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 Ketoprofen 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 Ketoprofen 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 4e7bceb6-dcb5-c5e0-e063-6294a90a101e, effective 20260402; matched on
openfda.generic_name.exact:"KETOPROFEN") - 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, 1,149 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 - ClinicalTrials.gov API v2 (query
KETOPROFEN, results-bearing studies sorted by enrollment)
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.