Diclofenac Epolamine side effects: what 4,257 FDA adverse event reports show
Drug class
Nonsteroidal anti-inflammatory drug (nsaid), and is
Who reports
4,257 reports · 35% serious · 113 with death outcome · 73% female
Used for
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. • DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal.
What it is
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised .
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-inflamma.
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.
- 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. 142 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 |
|---|---|---|---|---|---|---|
| Application site rash | 75 | 26.9 21.5–33.7ROR 27.4 · χ² 1,836 / p <1e-300 | 26.6 EB05 21.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · 73% consumer | no trial data cached |
| Application site pain | 75 | 16.8 13.4–21.1ROR 17.1 · χ² 1,098 / p 4e-241 | 16.7 EB05 13.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 81% consumer | no trial data cached |
| Product adhesion issue | 100 | 13.9 11.5–16.9ROR 14.2 · χ² 1,186 / p 4e-260 | 13.8 EB05 11.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=9 · 81% consumer | no trial data cached |
| Body height decreased | 27 | 12.3 8.5–18.0ROR 12.4 · χ² 269 / p 8e-61 | 11.7 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 · 80% consumer | no trial data cached |
| Application site pruritus | 54 | 11.7 9.0–15.3ROR 11.9 · χ² 519 / p 3e-115 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=2 · 85% consumer | no trial data cached |
| Application site irritation | 27 | 10.7 7.3–15.6ROR 10.8 · χ² 228 / p 1e-51 | 10.0 EB05 6.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · ♀ 95% (drug 73%) · 74% consumer | no trial data cached |
| Poor quality product administered | 22 | 10.6 7.0–16.1ROR 10.7 · χ² 182 / p 1e-41 | 9.7 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | 82% consumer | no trial data cached |
| Application site erythema | 55 | 10.3 7.9–13.4ROR 10.4 · χ² 453 / p 9e-101 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 77% consumer | no trial data cached |
| Secretion discharge | 20 | 8.0 5.2–12.4ROR 8.0 · χ² 115 / p 4e-27 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · 70% consumer | no trial data cached |
| Back disorder | 25 | 7.5 5.1–11.2ROR 7.6 · χ² 135 / p 1e-31 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 74% consumer | no trial data cached |
| Eosinophilia | 26 | 7.3 5.0–10.8ROR 7.4 · χ² 136 / p 1e-31 | 6.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 · ♀ 25% (drug 73%) | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 15 | 7.3 4.4–12.0ROR 7.3 · χ² 75 / p 3e-18 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Expired product administered | 48 | 7.1 5.4–9.5ROR 7.2 · χ² 247 / p 6e-56 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=9 · 79% consumer | no trial data cached |
| Obstructive airways disorder | 15 | 6.6 4.0–11.0ROR 6.6 · χ² 66 / p 2e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Drug effective for unapproved indication | 37 | 6.2 4.5–8.6ROR 6.3 · χ² 158 / p 2e-36 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 78% consumer | no trial data cached |
| Bursitis | 15 | 6.1 3.7–10.2ROR 6.1 · χ² 59 / p 7e-15 | 5.2 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Drug hypersensitivity | 236 | 6.0 5.3–6.8ROR 6.3 · χ² 984 / p 3e-216 | 5.9 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Drug ineffective for unapproved indication | 67 | 5.9 4.7–7.5ROR 6.0 · χ² 270 / p 6e-61 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 70% consumer | no trial data cached |
| Dermatitis contact | 13 | 5.6 3.3–9.7ROR 5.7 · χ² 45 / p 9e-12 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Intervertebral disc protrusion | 24 | 5.4 3.6–8.0ROR 5.4 · χ² 82 / p 8e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Intervertebral disc degeneration | 10 | 5.3 2.9–9.8ROR 5.3 · χ² 31 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Pneumothorax | 17 | 5.3 3.3–8.5ROR 5.3 · χ² 55 / p 7e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Fibromyalgia | 26 | 5.3 3.6–7.7ROR 5.3 · χ² 86 / p 1e-20 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 96% (drug 73%) | no trial data cached |
| Breast pain | 11 | 5.1 2.8–9.2ROR 5.1 · χ² 32 / p 7e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Drug effect incomplete | 38 | 5.1 3.7–7.0ROR 5.1 · χ² 121 / p 2e-28 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 71% consumer | no trial data cached |
| Drug administered at inappropriate site | 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 | Not in label — unassessed | serious n=4 | no trial data cached |
| Poor quality sleep | 20 | 4.6 3.0–7.1ROR 4.6 · χ² 53 / p 2e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 | no trial data cached |
| Intentional product misuse | 80 | 4.5 3.7–5.6ROR 4.6 · χ² 218 / p 1e-49 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Seasonal allergy | 13 | 4.5 2.6–7.8ROR 4.5 · χ² 32 / p 6e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Neuralgia | 22 | 4.5 2.9–6.8ROR 4.5 · χ² 56 / p 4e-14 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Hyponatraemia (low sodium) | 47 | 4.1 3.1–5.5ROR 4.2 · χ² 108 / p 1e-25 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 91% clinician | no trial data cached |
| Pelvic pain | 15 | 4.1 2.5–6.7ROR 4.1 · χ² 32 / p 9e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Conjunctivitis | 15 | 4.0 2.4–6.7ROR 4.0 · χ² 31 / p 1e-8 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Hypoaesthesia oral | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 7e-7 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Tinnitus (ringing in the ears) | 35 | 3.7 2.7–5.2ROR 3.8 · χ² 68 / p 9e-17 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 74% consumer | no trial data cached |
| Osteoarthritis | 32 | 3.7 2.6–5.2ROR 3.7 · χ² 61 / p 3e-15 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Hyperkalaemia (high potassium) | 26 | 3.7 2.5–5.4ROR 3.7 · χ² 48 / p 2e-12 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Skin reaction | 10 | 3.5 1.9–6.5ROR 3.5 · χ² 15 / p 4e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Chronic kidney disease | 54 | 3.5 2.7–4.5ROR 3.5 · χ² 93 / p 3e-22 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Hepatocellular injury | 10 | 3.5 1.9–6.4ROR 3.5 · χ² 15 / p 5e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 5.8 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 658 | 2.5 2.3–2.6ROR 2.7 · χ² 608 / p 2e-134 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 82% consumer | no trial data cached |
| Pain | 280 | 2.2 2.0–2.5ROR 2.3 · χ² 197 / p 5e-45 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.4 | no trial data cached |
| Drug hypersensitivity | 236 | 6.0 5.3–6.8ROR 6.3 · χ² 984 / p 3e-216 | 5.9 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Product adhesion issue | 100 | 13.9 11.5–16.9ROR 14.2 · χ² 1,186 / p 4e-260 | 13.8 EB05 11.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=9 · 81% consumer | no trial data cached |
| Abdominal discomfort | 97 | 2.9 2.3–3.5ROR 2.9 · χ² 116 / p 2e-27 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Feeling abnormal | 94 | 1.9 1.6–2.4ROR 1.9 · χ² 41 / p 7e-11 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.8 · 85% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 85 | 2.7 2.2–3.4ROR 2.8 · χ² 93 / p 2e-22 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 90% clinician | no trial data cached |
| Intentional product misuse | 80 | 4.5 3.7–5.6ROR 4.6 · χ² 218 / p 1e-49 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Erythema (skin redness) | 75 | 1.8 1.4–2.3ROR 1.8 · χ² 26 / p 2e-7 | 1.8 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Application site pain | 75 | 16.8 13.4–21.1ROR 17.1 · χ² 1,098 / p 4e-241 | 16.7 EB05 13.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 81% consumer | no trial data cached |
| Application site rash | 75 | 26.9 21.5–33.7ROR 27.4 · χ² 1,836 / p <1e-300 | 26.6 EB05 21.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · 73% consumer | no trial data cached |
| Drug ineffective for unapproved indication | 67 | 5.9 4.7–7.5ROR 6.0 · χ² 270 / p 6e-61 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 70% consumer | no trial data cached |
| Application site erythema | 55 | 10.3 7.9–13.4ROR 10.4 · χ² 453 / p 9e-101 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 77% consumer | no trial data cached |
| Chronic kidney disease | 54 | 3.5 2.7–4.5ROR 3.5 · χ² 93 / p 3e-22 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Application site pruritus | 54 | 11.7 9.0–15.3ROR 11.9 · χ² 519 / p 3e-115 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=2 · 85% 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.
- Body height decreased — n=27, PRR 12.3
- Poor quality product administered — n=22, PRR 10.6
- Secretion discharge — n=20, PRR 8.0
- Back disorder — n=25, PRR 7.5
- Intervertebral disc protrusion — n=24, PRR 5.4
- Fibromyalgia — n=26, PRR 5.3
- Neuralgia — n=22, PRR 4.5
- Hyponatraemia — n=47, PRR 4.1
- Tinnitus — n=35, PRR 3.7
- Chronic kidney disease — n=54, PRR 3.5
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 Diclofenac Epolamine?
In FDA FAERS, the most frequently co-reported reaction terms for Diclofenac Epolamine are pain, drug hypersensitivity, abdominal discomfort, feeling abnormal, acute kidney injury, erythema. 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 Diclofenac Epolamine 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-inflamma.
Do FAERS signals prove that Diclofenac Epolamine 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 1a5c4d2d-a819-4749-b4d4-7f2c099175a4, effective 20260608; matched on
openfda.generic_name.exact:"DICLOFENAC EPOLAMINE") - 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, 182 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.