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Drug · FAERS side-effect profile with label screen

Diclofenac Potassium side effects: what 10,743 FDA adverse event reports show

Diclofenac Potassium · Diclofenac Sodium · 1,005 reaction terms · 249,929 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal anti-inflammatory drug

FDA label, Indications wording

Brand names

Diclofenac Sodium

openFDA label

Who reports

10,743 reports · 78% serious · 4,166 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). ( 1 )

FDA label, Indications and Usage

What it is

Diclofenac sodium topical solution, USP contains 2% diclofenac sodium USP, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application.

FDA label, Description section

Boxed warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 1Labeled (related wording) 2Lab value / disease marker 7Not in label — unassessed 30

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 (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 965 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Grip strength	134	2,715.5 2,089.2–3,529.5ROR 2,749.8 · calibrated p 3e-22 ✓	969.7 EB05 839.5 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious n=134 · 97% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	379	2,605.8 2,235.5–3,037.5ROR 2,701.1 · calibrated p 1e-22 ✓	1,048.6 EB05 962.9 · IC025 +8.6 3/3 methods agree	Lab value / disease marker	serious n=379 · 95% clinician	not reported in cached trials
Hepatic enzyme	78	2,502.7 1,788.4–3,502.3ROR 2,521.0 · calibrated p 2e-21 ✓	857.7 EB05 709.5 · IC025 +6.7 3/3 methods agree	Labeled (related wording) related wording	serious n=78 · 100% clinician	not reported in cached trials
Lupus vulgaris	623	2,172.8 1,940.6–2,432.7ROR 2,306.5 · calibrated p 9e-22 ✓	989.9 EB05 926.4 · IC025 +9.0 3/3 methods agree	Not in label — unassessed	serious n=623 · 95% clinician	not reported in cached trials
C-reactive protein	474	2,162.4 1,899.1–2,462.1ROR 2,262.1 · calibrated p 1e-21 ✓	978.4 EB05 906.6 · IC025 +8.8 3/3 methods agree	Lab value / disease marker	serious n=474 · 97% clinician	not reported in cached trials
Deep vein thrombosis postoperative	977	1,961.3 1,797.8–2,139.7ROR 2,157.4 · calibrated p 2e-21 ✓	953.7 EB05 904.6 · IC025 +9.2 3/3 methods agree	Not in label — unassessed	serious n=977 · 94% clinician	not reported in cached trials
Swollen joint count	108	1,540.1 1,196.7–1,982.2ROR 1,555.8 · calibrated p 4e-19 ✓	742.6 EB05 632.3 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=108 · 94% clinician	not reported in cached trials
Swollen joint count increased	1,333	1,469.8 1,372.1–1,574.4ROR 1,677.8 · calibrated p 5e-20 ✓	824.0 EB05 787.5 · IC025 +9.2 3/3 methods agree	Lab value / disease marker	serious n=1,333 · 96% clinician	not reported in cached trials
Facet joint syndrome	1,289	1,361.2 1,270.8–1,458.1ROR 1,546.7 · calibrated p 1e-19 ✓	788.4 EB05 752.9 · IC025 +9.2 3/3 methods agree	Not in label — unassessed	serious n=1,289 · 97% clinician	not reported in cached trials
Rheumatic fever	1,761	1,329.0 1,254.5–1,407.9ROR 1,589.3 · calibrated p 9e-20 ✓	779.9 EB05 749.8 · IC025 +9.3 3/3 methods agree	Not in label — unassessed	serious n=1,761 · 96% clinician	not reported in cached trials
Retinitis	574	1,028.9 931.4–1,136.6ROR 1,086.9 · calibrated p 1e-17 ✓	656.1 EB05 612.3 · IC025 +8.6 3/3 methods agree	Not in label — unassessed	serious n=574 · 95% clinician	not reported in cached trials
Adjustment disorder with depressed mood	687	1,015.0 927.2–1,111.1ROR 1,084.3 · calibrated p 1e-17 ✓	652.8 EB05 612.8 · IC025 +8.7 3/3 methods agree	Not in label — unassessed	serious n=686 · 96% clinician	not reported in cached trials
Hypocholesterolaemia	99	929.7 732.0–1,180.9ROR 938.3 · calibrated p 1e-16 ✓	559.1 EB05 472.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=99 · 96% clinician	not reported in cached trials
Dislocation of vertebra	700	900.8 825.1–983.4ROR 963.5 · calibrated p 4e-17 ✓	603.8 EB05 567.2 · IC025 +8.6 3/3 methods agree	Not in label — unassessed	serious n=700 · 94% clinician	not reported in cached trials
X-ray abnormal	503	769.1 694.8–851.4ROR 806.9 · calibrated p 3e-16 ✓	538.5 EB05 500.2 · IC025 +8.3 3/3 methods agree	Lab value / disease marker	serious n=503 · 96% clinician	not reported in cached trials
Sleep disorder due to general medical condition, hypersomnia type	28	759.2 490.4–1,175.3ROR 761.2 · calibrated p 1e-14 ✓	396.7 EB05 288.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=28 · 93% clinician	not reported in cached trials
Duodenal ulcer perforation	2,026	747.2 712.4–783.7ROR 920.6 · calibrated p 7e-17 ✓	535.8 EB05 516.5 · IC025 +8.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 397.4 · 95% clinician	not reported in cached trials
Rheumatoid factor positive	1,569	732.1 692.9–773.5ROR 857.1 · calibrated p 2e-16 ✓	527.2 EB05 505.7 · IC025 +8.7 3/3 methods agree	Lab value / disease marker	serious n=1,569 · 96% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	1,728	629.2 598.0–662.1ROR 749.6 · calibrated p 7e-16 ✓	472.0 EB05 453.6 · IC025 +8.6 3/3 methods agree	Lab value / disease marker	serious PRR 351.7 · 95% clinician	not reported in cached trials
Peripheral venous disease	948	609.6 568.0–654.1ROR 668.5 · calibrated p 3e-15 ✓	458.9 EB05 434.9 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=948 · 95% clinician	not reported in cached trials
Seronegative arthritis	266	608.2 530.6–697.2ROR 623.6 · calibrated p 7e-15 ✓	447.5 EB05 404.1 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious n=266 · 94% clinician	not reported in cached trials
Helicobacter infection	2,082	502.3 480.5–525.1ROR 622.8 · calibrated p 5e-15 ✓	397.1 EB05 383.0 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 311.2 · 95% clinician	not reported in cached trials
Muscle injury	1,542	452.6 429.6–476.8ROR 528.3 · calibrated p 3e-14 ✓	365.0 EB05 349.9 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious PRR 293.4 · 97% clinician	not reported in cached trials
Porphyria acute	259	451.6 395.0–516.4ROR 462.8 · calibrated p 2e-13 ✓	356.4 EB05 321.4 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious n=259 · 94% clinician	not reported in cached trials
Acquired porphyria	13	439.1 240.5–801.7ROR 439.6 · calibrated p 1e-11 ✓	234.7 EB05 145.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
C-reactive protein abnormal	1,162	433.4 407.8–460.5ROR 485.8 · calibrated p 8e-14 ✓	351.9 EB05 335.2 · IC025 +8.2 3/3 methods agree	Lab value / disease marker	serious n=1,162 · 97% clinician	not reported in cached trials
Pemphigus	2,230	427.6 410.1–445.9ROR 539.3 · calibrated p 3e-14 ✓	349.0 EB05 337.0 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious PRR 259.4 · 95% clinician	not reported in cached trials
Bone erosion	619	414.1 380.4–450.7ROR 439.3 · calibrated p 2e-13 ✓	337.4 EB05 315.7 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious n=619 · 97% clinician	not reported in cached trials
Folliculitis	1,758	401.1 382.4–420.8ROR 479.4 · calibrated p 9e-14 ✓	330.9 EB05 318.2 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 288.4 · 97% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	92	397.1 317.5–496.6ROR 400.5 · calibrated p 1e-12 ✓	308.3 EB05 258.9 · IC025 +6.5 3/3 methods agree	Labeled (related wording) related wording	serious n=92 · 95% clinician	not reported in cached trials
Hand deformity	2,177	390.4 374.3–407.1ROR 489.3 · calibrated p 7e-14 ✓	323.8 EB05 312.5 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 260.9 · 95% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	1,049	380.6 357.2–405.5ROR 421.7 · calibrated p 3e-13 ✓	316.1 EB05 300.4 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious n=1,049 · 97% clinician	not reported in cached trials
Lip dry	1,386	357.8 338.9–377.7ROR 410.6 · calibrated p 4e-13 ✓	300.6 EB05 287.6 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious n=1,386 · 97% clinician	not reported in cached trials
Tender joint count	13	352.5 195.2–636.5ROR 352.9 · calibrated p 8e-11 ✓	207.6 EB05 129.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Breast cancer stage iii	962	343.7 321.7–367.1ROR 377.4 · calibrated p 1e-12 ✓	290.1 EB05 275.0 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious n=962 · 94% clinician	not reported in cached trials
Pericarditis	2,169	292.5 280.7–304.7ROR 366.2 · calibrated p 1e-12 ✓	253.5 EB05 244.6 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 189.2 · 95% clinician	not reported in cached trials
Synovitis	2,211	272.8 262.1–284.1ROR 343.3 · calibrated p 3e-12 ✓	238.6 EB05 230.4 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 185.0 · 95% clinician	not reported in cached trials
Musculoskeletal deformity	28	262.9 177.2–390.1ROR 263.6 · calibrated p 2e-10 ✓	200.0 EB05 145.2 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=28 · 100% clinician	not reported in cached trials
Hypercholesterolaemia	1,109	256.2 241.3–271.9ROR 285.6 · calibrated p 2e-11 ✓	225.3 EB05 214.4 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 177.5 · 96% clinician	not reported in cached trials
Joint range of motion decreased	1,528	252.2 239.9–265.1ROR 293.9 · calibrated p 1e-11 ✓	222.5 EB05 213.3 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 210.1 · 96% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Liver injury	3,047	19.919.3–20.5	signal
Interstitial lung disease	887	18.217.1–19.4	signal
Hyperglycaemia / diabetes	2,155	12.211.8–12.7	signal
Depression	1,074	7.57.1–7.9	signal
Pancreatitis	264	6.45.7–7.2	signal
Serious infection	2,336	5.95.7–6.1	signal
Gi bleeding	322	3.43.1–3.8	signal
Rhabdomyolysis / myopathy	104	2.52.1–3.0	signal
Thrombocytopenia	202	1.81.6–2.1	raised
Fall / fracture	341	1.71.6–1.9	raised
Anaphylaxis / angioedema	88	1.41.1–1.7	raised
Severe cutaneous reaction	42	1.10.8–1.5	no difference
Opportunistic infection	66	0.90.7–1.2	no difference
Suicidality	107	0.80.7–1.0	no difference
Venous thromboembolism	93	0.80.7–1.0	no difference
Hyponatraemia	33	0.80.6–1.1	no difference

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Diclofenac Potassium 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 (0 of 40 signal terms matched).

NCT00141102 — Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With (N=4484, PHASE4; 146 AE terms posted; arms: Celecoxib; Oral Diclofenac Plus Omeprazole)

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
Drug ineffective (drug did not work)	2,826	4.2 4.1–4.3ROR 5.3 · calibrated p 0.201	4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.2 · serious PRR 7.3	not reported in cached trials
Fatigue (tiredness)	2,577	6.5 6.3–6.7ROR 8.2 · calibrated p 0.061	6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.4 · serious PRR 8.7 · 90% clinician	not reported in cached trials
Rheumatoid arthritis	2,570	45.4 43.9–47.0ROR 59.3 · calibrated p 4e-6 ✓	44.3 EB05 42.9 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 44.4 · serious PRR 40.0 · 94% clinician	NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium (serious AE)
Off label use (used outside approved label)	2,492	5.6 5.4–5.8ROR 7.0 · calibrated p 0.098	5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 6.2 · serious PRR 7.4	not reported in cached trials
Pain	2,477	7.9 7.6–8.2ROR 9.9 · calibrated p 0.033 ✓	7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 8.2 · serious PRR 8.9	NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium (serious AE)
Rash	2,456	11.1 10.7–11.5ROR 14.1 · calibrated p 0.009 ✓	11.1 EB05 10.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 11.6 · serious PRR 17.8 · 92% clinician	not reported in cached trials
Systemic lupus erythematosus	2,403	142.3 137.2–147.6ROR 183.0 · calibrated p 9e-10 ✓	132.4 EB05 128.1 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 144.0 · serious PRR 100.5 · 95% clinician	not reported in cached trials
Joint swelling	2,366	39.1 37.7–40.5ROR 49.9 · calibrated p 1e-5 ✓	38.3 EB05 37.0 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 35.5 · serious PRR 48.7 · 95% clinician	not reported in cached trials
Wound	2,280	174.5 167.9–181.3ROR 221.2 · calibrated p 2e-10 ✓	159.8 EB05 154.4 · IC025 +7.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 172.2 · serious PRR 140.8 · 95% clinician	NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium (serious AE)
Pemphigus	2,230	427.6 410.1–445.9ROR 539.3 · calibrated p 3e-14 ✓	349.0 EB05 337.0 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious PRR 259.4 · 95% clinician	not reported in cached trials
Synovitis	2,211	272.8 262.1–284.1ROR 343.3 · calibrated p 3e-12 ✓	238.6 EB05 230.4 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 185.0 · 95% clinician	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	2,200	213.2 204.9–221.9ROR 267.9 · calibrated p 3e-11 ✓	191.7 EB05 185.1 · IC025 +7.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 205.3 · 95% clinician	not reported in cached trials
Swelling	2,184	46.7 45.0–48.5ROR 58.4 · calibrated p 5e-6 ✓	45.6 EB05 44.0 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 45.6 · serious PRR 54.5 · 95% clinician	not reported in cached trials
Abdominal discomfort	2,181	25.8 24.8–26.8ROR 32.1 · calibrated p 2e-4 ✓	25.5 EB05 24.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 26.9 · serious PRR 41.1 · 90% clinician	not reported in cached trials
Hand deformity	2,177	390.4 374.3–407.1ROR 489.3 · calibrated p 7e-14 ✓	323.8 EB05 312.5 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 260.9 · 95% clinician	not reported in cached trials

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.

Grip strength — n=134, PRR 2,715.5
Lupus vulgaris — n=623, PRR 2,172.8
Deep vein thrombosis postoperative — n=977, PRR 1,961.3
Swollen joint count — n=108, PRR 1,540.1
Facet joint syndrome — n=1,289, PRR 1,361.2
Rheumatic fever — n=1,761, PRR 1,329.0
Retinitis — n=574, PRR 1,028.9
Adjustment disorder with depressed mood — n=687, PRR 1,015.0
Hypocholesterolaemia — n=99, PRR 929.7
Dislocation of vertebra — n=700, PRR 900.8

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 Potassium?

In FDA FAERS, the most frequently co-reported reaction terms for Diclofenac Potassium are fatigue, rheumatoid arthritis, pain, rash, systemic lupus erythematosus, joint swelling. 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 Potassium have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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.

Do FAERS signals prove that Diclofenac Potassium 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 45321aec-368d-4ca4-a0c5-2ce56fae74b2, effective 20250529; matched on openfda.generic_name.exact:"DICLOFENAC")
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, field patient.drug.openfda.generic_name.exact, 1,005 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 DICLOFENAC, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.