Etodolac side effects: what 5,957 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
5,957 reports · 65% serious · 461 with death outcome · 66% female
Used for
Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
What it is
DESCRIPTION Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs).
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 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.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 554 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 |
|---|---|---|---|---|---|---|
| Intervertebral disc degeneration | 24 | 9.1 6.1–13.6ROR 9.1 · χ² 165 / p 6e-38 | 8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Rotator cuff syndrome | 28 | 7.7 5.3–11.1ROR 7.7 · χ² 155 / p 6e-36 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Gastric haemorrhage | 25 | 7.6 5.1–11.3ROR 7.6 · χ² 137 / p 7e-32 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 0% (drug 66%) · 92% clinician | no trial data cached |
| Chronic kidney disease | 163 | 7.5 6.4–8.7ROR 7.7 · χ² 913 / p 9e-201 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Gastric ulcer | 39 | 7.2 5.3–9.9ROR 7.3 · χ² 203 / p 3e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 39% (drug 66%) | no trial data cached |
| Hyperlipidaemia | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 107 / p 2e-25 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 43% (drug 66%) | no trial data cached |
| Intervertebral disc protrusion | 41 | 6.6 4.9–8.9ROR 6.6 · χ² 189 / p 3e-43 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 75% consumer | no trial data cached |
| Carpal tunnel syndrome | 26 | 6.5 4.4–9.6ROR 6.5 · χ² 116 / p 2e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| End stage renal disease | 34 | 6.5 4.7–9.1ROR 6.5 · χ² 153 / p 2e-35 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Economic problem | 27 | 6.2 4.2–9.0ROR 6.2 · χ² 112 / p 2e-26 | 5.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Bone disorder | 31 | 5.9 4.2–8.4ROR 6.0 · χ² 122 / p 9e-29 | 5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Atelectasis | 16 | 5.8 3.6–9.5ROR 5.8 · χ² 59 / p 8e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Osteopenia | 24 | 5.5 3.7–8.3ROR 5.6 · χ² 85 / p 2e-20 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Mydriasis | 20 | 5.5 3.5–8.5ROR 5.5 · χ² 69 / p 5e-17 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Osteoarthritis | 66 | 5.5 4.3–7.0ROR 5.5 · χ² 237 / p 9e-54 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.8 | no trial data cached |
| Vitamin d deficiency | 15 | 5.4 3.3–9.0ROR 5.4 · χ² 50 / p 9e-13 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Nerve compression | 14 | 5.4 3.2–9.0ROR 5.4 · χ² 45 / p 9e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Tendon rupture (torn tendon) | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 56 / p 4e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Psoriatic arthropathy | 58 | 5.1 3.9–6.6ROR 5.1 · χ² 186 / p 1e-42 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Renal failure acute | 62 | 5.1 4.0–6.5ROR 5.1 · χ² 199 / p 2e-45 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · ♀ 41% (drug 66%) · 91% clinician | no trial data cached |
| Anhedonia | 38 | 5.1 3.7–6.9ROR 5.1 · χ² 120 / p 4e-28 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 27% (drug 66%) | no trial data cached |
| Iron deficiency anaemia | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 37 / p 5e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Renal injury | 42 | 4.9 3.6–6.7ROR 5.0 · χ² 128 / p 7e-30 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Interstitial lung disease | 66 | 4.8 3.8–6.1ROR 4.9 · χ² 196 / p 9e-45 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Cholelithiasis | 44 | 4.7 3.5–6.3ROR 4.8 · χ² 126 / p 2e-29 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 90% (drug 66%) | no trial data cached |
| Renal tubular necrosis | 13 | 4.7 2.7–8.0ROR 4.7 · χ² 34 / p 3e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Upper gastrointestinal haemorrhage | 22 | 4.6 3.0–7.0ROR 4.6 · χ² 58 / p 1e-14 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 23% (drug 66%) | no trial data cached |
| Increased tendency to bruise | 12 | 4.6 2.6–8.1ROR 4.6 · χ² 30 / p 2e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Anorexia | 17 | 4.6 2.8–7.4ROR 4.6 · χ² 44 / p 2e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Local swelling | 23 | 4.6 3.0–6.9ROR 4.6 · χ² 61 / p 3e-15 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Tubulointerstitial nephritis | 24 | 4.5 3.0–6.7ROR 4.5 · χ² 62 / p 2e-15 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Disseminated intravascular coagulation | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 8e-12 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Cholecystitis | 15 | 4.4 2.7–7.4ROR 4.5 · χ² 37 / p 7e-10 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Sleep apnoea syndrome | 24 | 4.4 3.0–6.6ROR 4.4 · χ² 60 / p 5e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Spinal operation | 15 | 4.4 2.6–7.2ROR 4.4 · χ² 36 / p 1e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Haemorrhoids | 24 | 4.3 2.9–6.4ROR 4.3 · χ² 58 / p 1e-14 | 4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Blood alkaline phosphatase increased | 30 | 4.2 3.0–6.1ROR 4.3 · χ² 71 / p 2e-17 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · ♀ 45% (drug 66%) · 92% clinician | no trial data cached |
| Sciatica | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 43 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Obesity | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 43 / p 3e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Type 2 diabetes mellitus | 40 | 4.2 3.1–5.7ROR 4.2 · χ² 93 / p 2e-22 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | 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 |
|---|---|---|---|---|---|---|
| Pain | 354 | 2.0 1.8–2.2ROR 2.1 · χ² 188 / p 4e-43 | 2.0 EB05 1.9 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 1.9 | no trial data cached |
| Arthralgia (joint pain) | 285 | 2.4 2.2–2.7ROR 2.5 · χ² 241 / p 1e-54 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Rash | 204 | 1.7 1.4–1.9ROR 1.7 · χ² 53 / p 1e-13 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Pain in extremity | 174 | 2.1 1.8–2.4ROR 2.1 · χ² 97 / p 3e-23 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Fall | 173 | 1.8 1.6–2.1ROR 1.9 · χ² 65 / p 3e-16 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Chronic kidney disease | 163 | 7.5 6.4–8.7ROR 7.7 · χ² 913 / p 9e-201 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Anxiety | 151 | 1.9 1.6–2.2ROR 1.9 · χ² 60 / p 4e-15 | 1.9 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Renal failure (kidney failure) | 148 | 3.9 3.3–4.6ROR 4.0 · χ² 317 / p 3e-71 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Drug hypersensitivity | 147 | 2.7 2.3–3.1ROR 2.7 · χ² 153 / p 2e-35 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Back pain | 142 | 2.2 1.8–2.5ROR 2.2 · χ² 87 / p 5e-21 | 2.1 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Cough | 141 | 1.8 1.5–2.1ROR 1.8 · χ² 47 / p 3e-12 | 1.8 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 141 | 3.3 2.8–3.8ROR 3.3 · χ² 220 / p 4e-50 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Depression | 136 | 2.1 1.8–2.5ROR 2.1 · χ² 78 / p 7e-19 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Insomnia (trouble sleeping) | 135 | 1.8 1.5–2.1ROR 1.8 · χ² 46 / p 6e-12 | 1.8 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Injection site pain (pain where injected) | 129 | 1.5 1.3–1.8ROR 1.5 · χ² 21 / p 2e-6 | 1.5 EB05 1.3 · IC025 +0.3 | Likely indication confounding term in indications; also in warnings | serious PRR 1.4 · 72% 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.
- Intervertebral disc degeneration — n=24, PRR 9.1
- Rotator cuff syndrome — n=28, PRR 7.7
- Gastric haemorrhage — n=25, PRR 7.6
- Hyperlipidaemia — n=23, PRR 6.8
- Intervertebral disc protrusion — n=41, PRR 6.6
- Carpal tunnel syndrome — n=26, PRR 6.5
- End stage renal disease — n=34, PRR 6.5
- Bone disorder — n=31, PRR 5.9
- Osteopenia — n=24, PRR 5.5
- Mydriasis — n=20, PRR 5.5
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 Etodolac?
In FDA FAERS, the most frequently co-reported reaction terms for Etodolac are pain, arthralgia, rash, pain in extremity, fall, chronic kidney disease. 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 Etodolac 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 Etodolac 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 03458123-e27c-4447-9ef3-3bd32481cb97, effective 20260820; matched on
openfda.generic_name.exact:"ETODOLAC") - 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, 594 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.