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Drug · FAERS side-effect profile with label screen

Diclofenac Sodium side effects: what 149,524 FDA adverse event reports show

Diclofenac Sodium · Diclofenac Sodium · 1,199 reaction terms · 1,015,358 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

149,524 reports · 60% serious · 13,473 with death outcome · 68% 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 is a monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. It has a role as a non-steroidal anti-inflammatory drug, a non-narcotic analgesic, an antipyretic, an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, a xenobiotic, an...

PubChem CID 3033 (ChEBI)

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) 4Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 27

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.
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, 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). 1,159 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
Lupus vulgaris	955	596.1 514.9–690.1ROR 599.9 · calibrated p 1e-14 ✓	112.2 EB05 106.3 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=955 · ♀ 100% (drug 68%) · 96% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	5,583	535.4 505.3–567.2ROR 556.1 · calibrated p 2e-14 ✓	110.0 EB05 107.6 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious PRR 105.7 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	516	495.5 411.7–596.3ROR 497.2 · calibrated p 9e-14 ✓	107.9 EB05 100.3 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious n=516 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Swollen joint count increased	2,406	490.9 450.8–534.6ROR 498.9 · calibrated p 6e-14 ✓	108.0 EB05 104.4 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious n=2,404 · ♀ 100% (drug 68%) · 95% clinician	not reported in cached trials
Rheumatic fever	3,334	468.1 436.0–502.6ROR 478.8 · calibrated p 9e-14 ✓	106.9 EB05 103.9 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=3,333 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Deep vein thrombosis postoperative	1,448	407.4 367.8–451.4ROR 411.4 · calibrated p 5e-13 ✓	103.3 EB05 98.9 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=1,448 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Duodenal ulcer perforation	5,286	370.3 351.7–389.9ROR 383.9 · calibrated p 9e-13 ✓	100.9 EB05 98.6 · IC025 +6.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 96.4 · ♀ 99% (drug 68%) · 93% clinician	not reported in cached trials
Hepatic enzyme	96	313.9 218.4–451.0ROR 314.1 · calibrated p 3e-11 ✓	94.5 EB05 79.6 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=96 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
C-reactive protein	599	276.9 241.0–318.2ROR 278.1 · calibrated p 2e-11 ✓	92.2 EB05 86.2 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	serious n=599 · ♀ 100% (drug 68%) · 95% clinician	not reported in cached trials
Grip strength	150	260.7 198.6–342.4ROR 261.0 · calibrated p 8e-11 ✓	89.6 EB05 78.2 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=150 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Facet joint syndrome	2,037	260.2 241.7–280.1ROR 263.8 · calibrated p 3e-11 ✓	90.5 EB05 87.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=2,035 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Pemphigus	7,999	257.2 247.9–266.8ROR 271.6 · calibrated p 2e-11 ✓	90.2 EB05 88.5 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 86.5 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Rheumatoid factor positive	3,503	219.4 208.1–231.4ROR 224.7 · calibrated p 1e-10 ✓	85.0 EB05 82.7 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	serious n=3,501 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Fractional exhaled nitric oxide increased	99	188.8 139.4–255.8ROR 188.9 · calibrated p 1e-9 ✓	78.9 EB05 66.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=99 · ♀ 0% (drug 68%)	not reported in cached trials
Swollen joint count	137	177.5 137.7–228.7ROR 177.6 · calibrated p 2e-9 ✓	77.2 EB05 66.9 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=137 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Adjustment disorder with depressed mood	1,120	176.8 161.8–193.1ROR 178.1 · calibrated p 1e-9 ✓	77.7 EB05 74.0 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=1,120 · ♀ 100% (drug 68%) · 96% clinician	not reported in cached trials
Hand deformity	7,170	171.4 165.6–177.4ROR 180.0 · calibrated p 1e-9 ✓	76.8 EB05 75.3 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 79.8 · ♀ 100% (drug 68%) · 92% clinician	not reported in cached trials
Dislocation of vertebra	1,154	152.1 139.9–165.3ROR 153.2 · calibrated p 4e-9 ✓	72.6 EB05 69.2 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=1,154 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Helicobacter infection	5,179	145.6 140.1–151.4ROR 150.8 · calibrated p 4e-9 ✓	71.2 EB05 69.6 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 72.0 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Hypocholesterolaemia	154	141.0 112.6–176.5ROR 141.1 · calibrated p 1e-8 ✓	69.5 EB05 60.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=154 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Retinitis	822	136.7 124.1–150.5ROR 137.4 · calibrated p 1e-8 ✓	68.9 EB05 65.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=822 · ♀ 100% (drug 68%) · 96% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	259	127.5 107.6–150.9ROR 127.7 · calibrated p 2e-8 ✓	66.3 EB05 59.8 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=259 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
X-ray abnormal	848	127.4 116.0–139.9ROR 128.1 · calibrated p 2e-8 ✓	66.5 EB05 62.8 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=848 · ♀ 100% (drug 68%) · 97% clinician	not reported in cached trials
Muscle injury	3,855	124.7 119.4–130.2ROR 127.9 · calibrated p 2e-8 ✓	65.8 EB05 64.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 68.2 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Embolia cutis medicamentosa	351	109.5 95.2–126.0ROR 109.8 · calibrated p 6e-8 ✓	61.2 EB05 56.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=351 · 100% clinician	not reported in cached trials
Folliculitis	4,382	103.5 99.6–107.6ROR 106.6 · calibrated p 7e-8 ✓	59.4 EB05 58.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 66.8 · ♀ 100% (drug 68%) · 95% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	2,635	97.3 92.6–102.2ROR 99.0 · calibrated p 1e-7 ✓	57.3 EB05 55.5 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=2,630 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Peripheral venous disease	1,594	93.2 87.5–99.3ROR 94.2 · calibrated p 2e-7 ✓	55.9 EB05 53.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=1,589 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Product administered at inappropriate site	7,105	90.2 87.6–92.9ROR 94.6 · calibrated p 2e-7 ✓	54.8 EB05 53.8 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 50.0 · 100% consumer	not reported in cached trials
Pericarditis	6,393	87.3 84.7–90.1ROR 91.2 · calibrated p 2e-7 ✓	53.8 EB05 52.7 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 51.9 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Seronegative arthritis	419	83.5 74.0–94.3ROR 83.7 · calibrated p 5e-7 ✓	52.2 EB05 48.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=418 · ♀ 89% (drug 68%) · 100% clinician	not reported in cached trials
Synovitis	6,658	82.0 79.5–84.5ROR 85.7 · calibrated p 3e-7 ✓	51.7 EB05 50.7 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.7 · ♀ 98% (drug 68%) · 92% clinician	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	7,814	75.3 73.3–77.4ROR 79.4 · calibrated p 6e-7 ✓	49.0 EB05 48.1 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 67.6 · ♀ 100% (drug 68%) · 92% clinician	not reported in cached trials
Inspiratory capacity decreased	96	74.9 58.4–96.0ROR 74.9 · calibrated p 1e-6 ✓	48.4 EB05 40.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=96 · ♀ 0% (drug 68%) · 100% clinician	not reported in cached trials
Intestinal diaphragm disease	88	65.3 50.7–84.2ROR 65.4 · calibrated p 3e-6 ✓	44.2 EB05 37.0 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious n=88 · ♀ 0% (drug 68%) · 100% clinician	not reported in cached trials
C-reactive protein abnormal	1,901	59.0 55.9–62.3ROR 59.8 · calibrated p 4e-6 ✓	41.6 EB05 40.0 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=1,900 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Drug effect faster than expected	96	56.1 44.2–71.1ROR 56.1 · calibrated p 8e-6 ✓	39.8 EB05 33.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Ductus arteriosus stenosis foetal	119	54.3 43.9–67.1ROR 54.3 · calibrated p 1e-5 ✓	39.0 EB05 33.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=119 · 100% clinician	not reported in cached trials
Porphyria acute	355	48.4 42.9–54.6ROR 48.5 · calibrated p 2e-5 ✓	36.0 EB05 32.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=355 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Breast cancer stage iii	1,649	48.2 45.5–50.9ROR 48.7 · calibrated p 2e-5 ✓	35.9 EB05 34.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=1,649 · ♀ 100% (drug 68%) · 95% 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	10,952	5.25.1–5.3	signal
Interstitial lung disease	2,362	3.53.4–3.7	signal
Anaphylaxis / angioedema	2,590	2.92.8–3.1	signal
Gi bleeding	3,514	2.72.6–2.8	signal
Severe cutaneous reaction	1,221	2.32.2–2.5	signal
Hyperglycaemia / diabetes	5,385	2.22.1–2.3	signal
Serious infection	11,535	2.12.1–2.1	signal
Tendon disorder	564	2.11.9–2.3	raised
Kidney injury	6,483	2.02.0–2.1	raised
Depression	3,804	1.91.8–2.0	raised
Rhabdomyolysis / myopathy	1,048	1.81.7–1.9	raised
Fall / fracture	4,176	1.51.5–1.6	raised
Anaemia	3,202	1.51.5–1.6	raised
Hyponatraemia	797	1.41.3–1.5	raised
Pancreatitis	781	1.41.3–1.5	raised
Thrombocytopenia	1,742	1.11.1–1.2	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Diclofenac 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)	29,891	3.2 3.2–3.3ROR 3.8 · calibrated p 0.419	3.2 EB05 3.2 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.4 · serious PRR 3.7	not reported in cached trials
Pain	14,906	3.5 3.4–3.5ROR 3.7 · calibrated p 0.432	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 3.9 · serious PRR 4.6	NCT00141102: 1/2,237 (0.0%) on Diclofenac (serious AE)
Fatigue (tiredness)	13,384	2.4 2.4–2.5ROR 2.6 · calibrated p 0.779	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.5 · serious PRR 4.0	not reported in cached trials
Off label use (used outside approved label)	13,318	2.2 2.1–2.2ROR 2.3 · calibrated p 0.911	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.2 · serious PRR 2.5	not reported in cached trials
Product use in unapproved indication	13,274	8.0 7.9–8.1ROR 8.7 · calibrated p 0.051	7.6 EB05 7.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.8 · serious PRR 4.6 · 75% consumer	not reported in cached trials
Arthralgia (joint pain)	10,693	3.7 3.6–3.8ROR 3.9 · calibrated p 0.398	3.6 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.0 · serious PRR 5.7	not reported in cached trials
Rash	10,628	3.5 3.4–3.6ROR 3.7 · calibrated p 0.441	3.4 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.6 · serious PRR 6.5 · ♀ 90% (drug 68%)	not reported in cached trials
Rheumatoid arthritis	10,153	13.7 13.5–14.0ROR 14.7 · calibrated p 0.008 ✓	12.6 EB05 12.4 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 13.0 · serious PRR 14.5 · ♀ 97% (drug 68%)	NCT00141102: 1/2,237 (0.0%) on Diclofenac (serious AE)
Abdominal discomfort	9,354	8.3 8.1–8.4ROR 8.7 · calibrated p 0.050	7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 7.8 · serious PRR 15.9 · ♀ 96% (drug 68%)	not reported in cached trials
Product use issue	9,295	7.3 7.1–7.4ROR 7.7 · calibrated p 0.075	7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 6.7 · serious PRR 9.2	not reported in cached trials
Nausea	8,928	1.6 1.6–1.6ROR 1.6 · calibrated p 0.726	1.6 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.7 · serious PRR 2.5	NCT00141102: 3/2,237 (0.1%) on Diclofenac (serious AE)
Joint swelling	8,760	10.9 10.7–11.2ROR 11.5 · calibrated p 0.019 ✓	10.2 EB05 10.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 10.8 · serious PRR 16.2 · ♀ 91% (drug 68%)	not reported in cached trials
Alopecia (hair loss)	8,661	6.4 6.3–6.5ROR 6.7 · calibrated p 0.110	6.2 EB05 6.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 6.3 · serious PRR 12.2 · ♀ 98% (drug 68%)	not reported in cached trials
Headache	8,316	1.9 1.8–1.9ROR 1.9 · calibrated p 0.902	1.9 EB05 1.8 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 3.2	NCT00141102: 1/2,237 (0.0%) on Diclofenac (serious AE)
Systemic lupus erythematosus	8,209	42.2 41.2–43.2ROR 44.6 · calibrated p 3e-5 ✓	32.5 EB05 31.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 47.6 · serious PRR 31.9 · ♀ 100% (drug 68%) · 92% 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.

Lupus vulgaris — n=955, PRR 596.1
Rheumatic fever — n=3,334, PRR 468.1
Deep vein thrombosis postoperative — n=1,448, PRR 407.4
Grip strength — n=150, PRR 260.7
Facet joint syndrome — n=2,037, PRR 260.2
Pemphigus — n=7,999, PRR 257.2
Fractional exhaled nitric oxide increased — n=99, PRR 188.8
Swollen joint count — n=137, PRR 177.5
Adjustment disorder with depressed mood — n=1,120, PRR 176.8
Hand deformity — n=7,170, PRR 171.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.

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?

In FDA FAERS, the most frequently co-reported reaction terms for Diclofenac are pain, fatigue, arthralgia, rash, rheumatoid arthritis, abdominal discomfort. 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 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 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 3033 description (ChEBI)
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, 1,199 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.