Drug · FAERS side-effect profile with label screen

Diclofenac and Misoprostol side effects: what 435 FDA adverse event reports show

Diclofenac Sodium/Misoprostol · 47 reaction terms · 1,139 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal anti-inflammatory drug

FDA label, Indications wording of the closest related product

Label matched

Diclofenac (Diclofenac Sodium)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

435 reports · 71% serious · 18 with death outcome · 86% 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 39 strongest signals

Labeled adverse reaction 7Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 6Lab value / disease marker 6Not in label — unassessed 14

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. 8 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
Red blood cell sedimentation rate increased	43	187.2 140.8–248.7ROR 207.5 · χ² 7,751 / p <1e-300	172.3 EB05 133.2 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious PRR 172.9 · 100% clinician	no trial data cached
Secretion discharge	43	167.9 126.4–223.2ROR 186.2 · χ² 6,950 / p <1e-300	155.9 EB05 120.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 224.7 · 98% clinician	no trial data cached
Platelet count increased	43	158.8 119.5–211.0ROR 176.1 · χ² 6,568 / p <1e-300	148.0 EB05 114.5 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious PRR 170.7 · 100% clinician	no trial data cached
Pulmonary mass	31	100.5 71.5–141.1ROR 108.1 · χ² 2,950 / p <1e-300	94.6 EB05 69.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 89.4	no trial data cached
Skin laceration	19	84.7 54.6–131.6ROR 88.6 · χ² 1,488 / p <1e-300	78.2 EB05 52.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 94.9	no trial data cached
Blood iron decreased	18	73.5 46.8–115.6ROR 76.7 · χ² 1,215 / p 2e-266	68.3 EB05 45.7 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 81.7	no trial data cached
Helicobacter infection	15	70.9 43.1–116.6ROR 73.3 · χ² 963 / p 8e-212	65.2 EB05 41.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 61.1	no trial data cached
Tooth abscess	15	70.7 43.0–116.3ROR 73.2 · χ² 961 / p 3e-211	65.0 EB05 41.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 75.8	no trial data cached
Pharyngitis	17	65.7 41.2–104.7ROR 68.3 · χ² 1,019 / p 8e-224	61.3 EB05 40.5 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 65.4	no trial data cached
Staphylococcal infection	43	62.5 47.1–83.1ROR 69.3 · χ² 2,544 / p <1e-300	60.9 EB05 47.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 56.4 · 100% clinician	no trial data cached
Ankylosing spondylitis	16	59.1 36.5–95.7ROR 61.3 · χ² 856 / p 1e-188	55.4 EB05 36.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 55.1	no trial data cached
Lower respiratory tract infection	55	58.4 45.6–74.8ROR 66.7 · χ² 3,051 / p <1e-300	57.3 EB05 45.7 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 50.5	no trial data cached
Pemphigus	13	50.3 29.5–86.0ROR 51.9 · χ² 580 / p 2e-128	47.0 EB05 29.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 41.2	no trial data cached
Blood pressure fluctuation	23	46.0 30.9–68.5ROR 48.5 · χ² 968 / p 7e-213	44.4 EB05 31.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 47.5	no trial data cached
Blood pressure systolic increased	17	41.8 26.2–66.6ROR 43.4 · χ² 636 / p 1e-140	40.0 EB05 26.5 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 37.2	no trial data cached
Therapeutic product effect incomplete	60	40.8 32.3–51.7ROR 47.2 · χ² 2,298 / p <1e-300	40.3 EB05 32.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 61.7 · 97% clinician	no trial data cached
Pericarditis	14	40.4 24.1–67.7ROR 41.7 · χ² 500 / p 6e-111	38.5 EB05 24.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 33.3	no trial data cached
Sleep apnoea syndrome	16	40.3 24.9–65.1ROR 41.8 · χ² 574 / p 4e-127	38.5 EB05 25.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 36.7	no trial data cached
Ear pain	16	39.6 24.5–64.1ROR 41.1 · χ² 564 / p 5e-125	37.9 EB05 24.8 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 48.9	no trial data cached
Drug intolerance	78	39.0 31.9–47.7ROR 47.3 · χ² 2,861 / p <1e-300	38.6 EB05 32.0 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 49.3 · 96% clinician	no trial data cached
Synovitis	12	32.0 18.3–55.9ROR 32.9 · χ² 330 / p 5e-74	30.6 EB05 18.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.4	no trial data cached
Viral infection	21	30.4 20.0–46.1ROR 31.9 · χ² 569 / p 6e-126	29.7 EB05 20.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.9 · 90% clinician	no trial data cached
Localised infection	15	29.8 18.1–49.0ROR 30.9 · χ² 390 / p 5e-87	28.8 EB05 18.5 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 31.6	no trial data cached
Irritable bowel syndrome	13	29.3 17.1–50.0ROR 30.1 · χ² 327 / p 2e-73	28.2 EB05 17.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.4	no trial data cached
Body temperature increased	12	28.2 16.1–49.3ROR 29.0 · χ² 288 / p 6e-65	27.1 EB05 16.4 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 28.4	no trial data cached
Infection	82	27.4 22.5–33.3ROR 33.5 · χ² 2,070 / p <1e-300	27.2 EB05 22.6 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.1 · 93% clinician	no trial data cached
Arthritis	44	26.9 20.3–35.6ROR 29.8 · χ² 1,074 / p 8e-236	26.6 EB05 20.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 32.6	no trial data cached
Liver injury	13	25.9 15.1–44.2ROR 26.6 · χ² 287 / p 1e-64	24.9 EB05 15.4 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.9	no trial data cached
Therapeutic response shortened	17	25.7 16.1–41.0ROR 26.7 · χ² 380 / p 7e-85	25.0 EB05 16.5 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 61.7	no trial data cached
Impaired work ability	11	24.7 13.8–44.2ROR 25.3 · χ² 227 / p 1e-51	23.6 EB05 13.8 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.8	no trial data cached
Drug hypersensitivity	98	24.3 20.4–28.9ROR 31.0 · χ² 2,183 / p <1e-300	24.2 EB05 20.4 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.9	no trial data cached
Wound	14	24.2 14.5–40.6ROR 25.0 · χ² 289 / p 4e-65	23.5 EB05 14.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.6	no trial data cached
Rheumatoid arthritis	51	21.7 16.8–28.1ROR 24.4 · χ² 991 / p 7e-218	21.5 EB05 17.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.3	no trial data cached
Contraindicated product administered	12	19.1 11.0–33.4ROR 19.7 · χ² 189 / p 3e-43	18.2 EB05 10.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 19.5	no trial data cached
Pain in jaw	11	18.7 10.4–33.5ROR 19.1 · χ² 167 / p 2e-38	17.6 EB05 9.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 24.8	no trial data cached
Systemic lupus erythematosus	13	17.7 10.3–30.2ROR 18.2 · χ² 188 / p 3e-43	16.8 EB05 9.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Psoriatic arthropathy	14	16.7 10.0–28.0ROR 17.3 · χ² 192 / p 5e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 17.2	no trial data cached
Therapeutic product effect decreased	14	15.2 9.1–25.4ROR 15.6 · χ² 172 / p 2e-39	14.2 EB05 8.2 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 24.5	no trial data cached
Disease recurrence	15	15.1 9.2–24.9ROR 15.6 · χ² 184 / p 3e-42	14.2 EB05 8.5 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 21.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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 hypersensitivity	98	24.3 20.4–28.9ROR 31.0 · χ² 2,183 / p <1e-300	24.2 EB05 20.4 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.9	no trial data cached
Infection	82	27.4 22.5–33.3ROR 33.5 · χ² 2,070 / p <1e-300	27.2 EB05 22.6 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.1 · 93% clinician	no trial data cached
Drug intolerance	78	39.0 31.9–47.7ROR 47.3 · χ² 2,861 / p <1e-300	38.6 EB05 32.0 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 49.3 · 96% clinician	no trial data cached
Therapeutic product effect incomplete	60	40.8 32.3–51.7ROR 47.2 · χ² 2,298 / p <1e-300	40.3 EB05 32.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 61.7 · 97% clinician	no trial data cached
Lower respiratory tract infection	55	58.4 45.6–74.8ROR 66.7 · χ² 3,051 / p <1e-300	57.3 EB05 45.7 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 50.5	no trial data cached
Rheumatoid arthritis	51	21.7 16.8–28.1ROR 24.4 · χ² 991 / p 7e-218	21.5 EB05 17.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.3	no trial data cached
Arthritis	44	26.9 20.3–35.6ROR 29.8 · χ² 1,074 / p 8e-236	26.6 EB05 20.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 32.6	no trial data cached
Staphylococcal infection	43	62.5 47.1–83.1ROR 69.3 · χ² 2,544 / p <1e-300	60.9 EB05 47.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 56.4 · 100% clinician	no trial data cached
Platelet count increased	43	158.8 119.5–211.0ROR 176.1 · χ² 6,568 / p <1e-300	148.0 EB05 114.5 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious PRR 170.7 · 100% clinician	no trial data cached
Secretion discharge	43	167.9 126.4–223.2ROR 186.2 · χ² 6,950 / p <1e-300	155.9 EB05 120.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 224.7 · 98% clinician	no trial data cached
Red blood cell sedimentation rate increased	43	187.2 140.8–248.7ROR 207.5 · χ² 7,751 / p <1e-300	172.3 EB05 133.2 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious PRR 172.9 · 100% clinician	no trial data cached
Pulmonary mass	31	100.5 71.5–141.1ROR 108.1 · χ² 2,950 / p <1e-300	94.6 EB05 69.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 89.4	no trial data cached
Blood pressure fluctuation	23	46.0 30.9–68.5ROR 48.5 · χ² 968 / p 7e-213	44.4 EB05 31.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 47.5	no trial data cached
Viral infection	21	30.4 20.0–46.1ROR 31.9 · χ² 569 / p 6e-126	29.7 EB05 20.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.9 · 90% clinician	no trial data cached
Skin laceration	19	84.7 54.6–131.6ROR 88.6 · χ² 1,488 / p <1e-300	78.2 EB05 52.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 94.9	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.

Secretion discharge — n=43, PRR 167.9
Pulmonary mass — n=31, PRR 100.5
Staphylococcal infection — n=43, PRR 62.5

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 and Misoprostol?

In FDA FAERS, the most frequently co-reported reaction terms for Diclofenac and Misoprostol are drug hypersensitivity, infection, lower respiratory tract infection, rheumatoid arthritis, arthritis, staphylococcal infection. 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 and Misoprostol 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 and Misoprostol 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, 47 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.