Diclofenac Potassium Tablets side effects: what 8,373 FDA adverse event reports show
Drug class
Nonsteroidal anti-inflammatory drug
Brand names
Diclofenac Sodium
Who reports
8,373 reports · 90% serious · 4,116 with death outcome · 88% female
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 )
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.
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.
Causality screen of the 40 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 (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). 939 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 |
|---|---|---|---|---|---|---|
| Grip strength | 134 | 3,484.9 2,681.7–4,528.8ROR 3,541.6 · calibrated p 1e-23 ✓ | 1,196.8 EB05 1,036.1 · 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 | 3,344.2 2,869.9–3,896.9ROR 3,502.7 · calibrated p 4e-24 ✓ | 1,325.4 EB05 1,217.1 · IC025 +8.8 3/3 methods agree | Lab value / disease marker | serious n=379 · 95% clinician | not reported in cached trials |
| Hepatic enzyme | 78 | 3,211.9 2,295.5–4,494.0ROR 3,242.0 · calibrated p 9e-23 ✓ | 1,038.1 EB05 858.7 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=78 · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 623 | 2,788.4 2,491.6–3,120.6ROR 3,012.5 · calibrated p 2e-23 ✓ | 1,259.3 EB05 1,178.5 · IC025 +9.2 3/3 methods agree | Not in label — unassessed | serious n=623 · 95% clinician | not reported in cached trials |
| C-reactive protein | 474 | 2,775.1 2,438.2–3,158.5ROR 2,941.6 · calibrated p 4e-23 ✓ | 1,241.4 EB05 1,150.4 · IC025 +9.0 3/3 methods agree | Lab value / disease marker | serious n=474 · 97% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 977 | 2,517.0 2,308.5–2,744.4ROR 2,849.4 · calibrated p 5e-23 ✓ | 1,217.3 EB05 1,154.6 · IC025 +9.5 3/3 methods agree | Not in label — unassessed | serious n=977 · 94% clinician | not reported in cached trials |
| Swollen joint count | 108 | 1,976.5 1,536.0–2,543.3ROR 2,002.3 · calibrated p 2e-20 ✓ | 918.3 EB05 781.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=108 · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 1,333 | 1,886.2 1,762.3–2,019.0ROR 2,243.3 · calibrated p 1e-21 ✓ | 1,053.7 EB05 1,007.1 · IC025 +9.5 3/3 methods agree | Lab value / disease marker | serious n=1,333 · 96% clinician | not reported in cached trials |
| Facet joint syndrome | 1,289 | 1,746.9 1,632.0–1,869.9ROR 2,064.7 · calibrated p 3e-21 ✓ | 1,008.3 EB05 962.9 · IC025 +9.4 3/3 methods agree | Not in label — unassessed | serious n=1,289 · 97% clinician | not reported in cached trials |
| Rheumatic fever | 1,761 | 1,705.5 1,611.3–1,805.2ROR 2,159.6 · calibrated p 2e-21 ✓ | 998.4 EB05 959.8 · IC025 +9.5 3/3 methods agree | Not in label — unassessed | serious n=1,761 · 96% clinician | not reported in cached trials |
| Retinitis | 574 | 1,320.4 1,195.9–1,457.9ROR 1,417.6 · calibrated p 4e-19 ✓ | 836.7 EB05 780.8 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=574 · 95% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 684 | 1,294.0 1,182.6–1,415.8ROR 1,409.0 · calibrated p 4e-19 ✓ | 829.7 EB05 778.8 · IC025 +8.9 3/3 methods agree | Not in label — unassessed | serious n=684 · 96% clinician | not reported in cached trials |
| Hypocholesterolaemia | 99 | 1,193.1 939.6–1,515.2ROR 1,207.4 · calibrated p 7e-18 ✓ | 695.9 EB05 588.2 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=99 · 96% clinician | not reported in cached trials |
| Dislocation of vertebra | 700 | 1,156.1 1,059.6–1,261.3ROR 1,261.4 · calibrated p 2e-18 ✓ | 771.1 EB05 724.4 · IC025 +8.9 3/3 methods agree | Not in label — unassessed | serious n=700 · 94% clinician | not reported in cached trials |
| X-ray abnormal | 503 | 987.1 892.1–1,092.1ROR 1,050.1 · calibrated p 2e-17 ✓ | 687.0 EB05 638.1 · IC025 +8.6 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 | 974.3 629.5–1,508.1ROR 977.6 · calibrated p 7e-16 ✓ | 472.4 EB05 343.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=28 · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,025 | 958.3 914.6–1,004.0ROR 1,263.7 · calibrated p 2e-18 ✓ | 686.2 EB05 661.5 · IC025 +9.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 439.6 · 95% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,569 | 939.5 890.1–991.7ROR 1,156.0 · calibrated p 5e-18 ✓ | 675.3 EB05 647.7 · IC025 +9.0 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 | 1,727 | 806.9 767.6–848.2ROR 1,016.3 · calibrated p 2e-17 ✓ | 604.4 EB05 580.8 · IC025 +8.9 3/3 methods agree | Lab value / disease marker | serious PRR 389.1 · 95% clinician | not reported in cached trials |
| Peripheral venous disease | 948 | 782.3 729.5–838.9ROR 882.1 · calibrated p 1e-16 ✓ | 587.3 EB05 556.6 · IC025 +8.7 3/3 methods agree | Not in label — unassessed | serious n=948 · 95% clinician | not reported in cached trials |
| Seronegative arthritis | 266 | 780.5 681.1–894.4ROR 806.1 · calibrated p 4e-16 ✓ | 568.9 EB05 513.8 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=266 · 94% clinician | not reported in cached trials |
| Helicobacter infection | 2,081 | 644.2 617.0–672.7ROR 857.0 · calibrated p 2e-16 ✓ | 508.8 EB05 490.7 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious PRR 344.3 · 95% clinician | not reported in cached trials |
| Muscle injury | 1,541 | 580.4 551.4–610.9ROR 711.1 · calibrated p 1e-15 ✓ | 467.4 EB05 448.2 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious PRR 324.6 · 97% clinician | not reported in cached trials |
| Porphyria acute | 259 | 579.6 507.1–662.5ROR 598.1 · calibrated p 1e-14 ✓ | 453.9 EB05 409.3 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=259 · 94% clinician | not reported in cached trials |
| Acquired porphyria | 13 | 563.5 308.6–1,028.8ROR 564.4 · calibrated p 1e-12 ✓ | 274.1 EB05 170.5 · 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 | 556.2 523.8–590.5ROR 645.6 · calibrated p 4e-15 ✓ | 450.8 EB05 429.4 · IC025 +8.5 3/3 methods agree | Lab value / disease marker | serious n=1,162 · 97% clinician | not reported in cached trials |
| Pemphigus | 2,229 | 548.5 526.6–571.2ROR 747.1 · calibrated p 7e-16 ✓ | 447.3 EB05 431.9 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious PRR 287.0 · 95% clinician | not reported in cached trials |
| Bone erosion | 619 | 531.4 488.5–578.0ROR 573.7 · calibrated p 1e-14 ✓ | 431.6 EB05 403.8 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=619 · 97% clinician | not reported in cached trials |
| Folliculitis | 1,757 | 514.5 491.0–539.1ROR 650.8 · calibrated p 3e-15 ✓ | 424.0 EB05 407.6 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious PRR 319.1 · 97% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 92 | 509.6 407.6–637.2ROR 515.3 · calibrated p 8e-14 ✓ | 388.4 EB05 326.2 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=92 · 95% clinician | not reported in cached trials |
| Hand deformity | 2,176 | 500.7 480.7–521.6ROR 676.2 · calibrated p 2e-15 ✓ | 415.0 EB05 400.5 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious PRR 288.7 · 95% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,049 | 488.5 458.8–520.0ROR 558.3 · calibrated p 2e-14 ✓ | 405.0 EB05 384.8 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=1,049 · 97% clinician | not reported in cached trials |
| Lip dry | 1,386 | 459.1 435.4–484.2ROR 550.0 · calibrated p 2e-14 ✓ | 385.3 EB05 368.6 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=1,386 · 97% clinician | not reported in cached trials |
| Tender joint count | 13 | 452.4 250.5–816.8ROR 453.1 · calibrated p 9e-12 ✓ | 245.0 EB05 152.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Breast cancer stage iii | 962 | 441.0 413.2–470.7ROR 498.2 · calibrated p 6e-14 ✓ | 371.6 EB05 352.3 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=962 · 94% clinician | not reported in cached trials |
| Pericarditis | 2,168 | 375.1 360.5–390.3ROR 505.9 · calibrated p 5e-14 ✓ | 324.9 EB05 313.6 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious PRR 209.3 · 95% clinician | not reported in cached trials |
| Synovitis | 2,209 | 349.8 336.4–363.7ROR 474.8 · calibrated p 1e-13 ✓ | 305.7 EB05 295.2 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 204.6 · 95% clinician | not reported in cached trials |
| Musculoskeletal deformity | 28 | 337.5 227.5–500.6ROR 338.6 · calibrated p 2e-11 ✓ | 247.0 EB05 179.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Hypercholesterolaemia | 1,108 | 328.4 309.6–348.4ROR 378.4 · calibrated p 1e-12 ✓ | 288.6 EB05 274.6 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 196.3 · 96% clinician | not reported in cached trials |
| Joint range of motion decreased | 1,527 | 323.4 308.0–339.6ROR 395.3 · calibrated p 6e-13 ✓ | 285.1 EB05 273.3 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 232.4 · 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 | 3,035 | 25.424.7–26.2 | signal |
| Interstitial lung disease | 887 | 23.421.9–24.9 | signal |
| Hyperglycaemia / diabetes | 2,144 | 15.615.1–16.2 | signal |
| Depression | 1,028 | 9.28.7–9.7 | signal |
| Pancreatitis | 256 | 8.07.1–9.0 | signal |
| Serious infection | 2,276 | 7.47.1–7.7 | signal |
| Gi bleeding | 310 | 4.23.8–4.7 | signal |
| Rhabdomyolysis / myopathy | 102 | 3.22.6–3.8 | signal |
| Thrombocytopenia | 199 | 2.32.0–2.6 | raised |
| Fall / fracture | 298 | 2.01.8–2.2 | raised |
| Anaphylaxis / angioedema | 76 | 1.51.2–1.9 | raised |
| Severe cutaneous reaction | 41 | 1.41.0–1.9 | raised |
| Opportunistic infection | 55 | 1.00.8–1.3 | no difference |
| Hyponatraemia | 30 | 0.90.7–1.3 | no difference |
| Venous thromboembolism | 77 | 0.90.7–1.1 | no difference |
| Suicidality | 75 | 0.80.6–1.0 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Diclofenac Potassium Tablets 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 |
|---|---|---|---|---|---|---|
| Rheumatoid arthritis | 2,550 | 57.8 55.9–59.7ROR 82.7 · calibrated p 5e-7 ✓ | 56.5 EB05 54.6 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 53.3 · serious PRR 44.0 · 94% clinician | NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium Tablets (serious AE) |
| Fatigue (tiredness) | 2,452 | 7.9 7.7–8.2ROR 10.8 · calibrated p 0.025 ✓ | 7.9 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 7.4 · serious PRR 9.4 · 93% clinician | not reported in cached trials |
| Rash | 2,408 | 14.0 13.5–14.5ROR 19.2 · calibrated p 0.002 ✓ | 13.9 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 13.9 · serious PRR 19.6 · 93% clinician | not reported in cached trials |
| Systemic lupus erythematosus | 2,399 | 182.3 175.9–188.9ROR 255.1 · calibrated p 4e-11 ✓ | 169.6 EB05 164.0 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 174.7 · serious PRR 111.1 · 95% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,381 | 4.5 4.4–4.7ROR 5.9 · calibrated p 0.154 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.7 · serious PRR 7.9 | not reported in cached trials |
| Pain | 2,381 | 9.7 9.4–10.1ROR 13.2 · calibrated p 0.012 ✓ | 9.7 EB05 9.4 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 9.5 · serious PRR 9.6 · 91% clinician | NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium Tablets (serious AE) |
| Off label use (used outside approved label) | 2,360 | 6.8 6.6–7.1ROR 9.1 · calibrated p 0.044 ✓ | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.3 · serious PRR 8.1 · 92% clinician | not reported in cached trials |
| Joint swelling | 2,344 | 49.7 48.0–51.5ROR 68.6 · calibrated p 2e-6 ✓ | 48.7 EB05 47.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 42.5 · serious PRR 53.5 · 95% clinician | not reported in cached trials |
| Wound | 2,279 | 223.8 215.6–232.3ROR 307.1 · calibrated p 8e-12 ✓ | 204.9 EB05 198.0 · IC025 +7.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 208.6 · serious PRR 155.8 · 96% clinician | NCT00141102: 1/2,237 (0.0%) on Diclofenac Potassium Tablets (serious AE) |
| Pemphigus | 2,229 | 548.5 526.6–571.2ROR 747.1 · calibrated p 7e-16 ✓ | 447.3 EB05 431.9 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious PRR 287.0 · 95% clinician | not reported in cached trials |
| Synovitis | 2,209 | 349.8 336.4–363.7ROR 474.8 · calibrated p 1e-13 ✓ | 305.7 EB05 295.2 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 204.6 · 95% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 2,198 | 273.4 263.0–284.1ROR 370.3 · calibrated p 1e-12 ✓ | 245.7 EB05 237.2 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 227.0 · 95% clinician | not reported in cached trials |
| Hand deformity | 2,176 | 500.7 480.7–521.6ROR 676.2 · calibrated p 2e-15 ✓ | 415.0 EB05 400.5 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious PRR 288.7 · 95% clinician | not reported in cached trials |
| Swelling | 2,175 | 59.7 57.6–62.0ROR 80.3 · calibrated p 6e-7 ✓ | 58.3 EB05 56.3 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 55.3 · serious PRR 60.2 · 95% clinician | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 2,172 | 85.2 82.1–88.4ROR 114.6 · calibrated p 4e-8 ✓ | 82.3 EB05 79.4 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 69.6 · serious PRR 66.2 · 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 3,484.9
- Lupus vulgaris — n=623, PRR 2,788.4
- Deep vein thrombosis postoperative — n=977, PRR 2,517.0
- Swollen joint count — n=108, PRR 1,976.5
- Facet joint syndrome — n=1,289, PRR 1,746.9
- Rheumatic fever — n=1,761, PRR 1,705.5
- Retinitis — n=574, PRR 1,320.4
- Adjustment disorder with depressed mood — n=684, PRR 1,294.0
- Hypocholesterolaemia — n=99, PRR 1,193.1
- Dislocation of vertebra — n=700, PRR 1,156.1
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 Tablets?
In FDA FAERS, the most frequently co-reported reaction terms for Diclofenac Potassium Tablets are rheumatoid arthritis, fatigue, rash, systemic lupus erythematosus, pain, 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 Tablets 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 Tablets 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, fieldpatient.drug.openfda.generic_name.exact, 979 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.