Drug · FAERS side-effect profile with label screen
Diatrizoate Meglumine side effects: what 148 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Cystografin
openFDA label
Who reports
148 reports · 91% serious · 87 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cystografin is indicated for retrograde cystourethrography.
FDA label, Indications and Usage
What it is
DESCRIPTION Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution.
FDA label, Description section
Boxed warning
None in the current 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
Reporting / coding artifact 8Lab value / disease marker 1No label text to screen 30
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pemphigus | 63 | 721.6 597.9–870.8ROR 1,255.7 · χ² 44,413 / p <1e-300 | 588.7 EB05 476.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 457.8 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Pericarditis | 64 | 546.2 453.8–657.3ROR 961.6 · χ² 34,179 / p <1e-300 | 467.6 EB05 379.1 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 348.7 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Synovitis | 59 | 464.7 381.0–566.6ROR 772.0 · χ² 26,769 / p <1e-300 | 402.5 EB05 323.4 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 308.4 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Wound | 63 | 321.8 266.7–388.1ROR 559.5 · χ² 19,806 / p <1e-300 | 292.5 EB05 236.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 243.1 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Back injury | 24 | 314.7 218.1–454.1ROR 375.4 · χ² 7,182 / p <1e-300 | 251.3 EB05 177.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 264.4 · ♀ 100% (drug 77%) · 96% clinician | no trial data cached |
| Contraindicated product administered | 58 | 272.9 223.2–333.7ROR 448.2 · χ² 15,436 / p <1e-300 | 250.0 EB05 200.5 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 215.8 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 64 | 269.0 223.6–323.6ROR 473.2 · χ² 16,815 / p <1e-300 | 248.6 EB05 201.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.9 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Systemic lupus erythematosus | 63 | 252.8 209.6–304.9ROR 439.4 · χ² 15,545 / p <1e-300 | 234.4 EB05 189.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| C-reactive protein increased | 61 | 238.0 196.3–288.6ROR 404.2 · χ² 14,163 / p <1e-300 | 221.2 EB05 178.4 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 157.3 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Wound infection | 18 | 235.0 152.4–362.5ROR 267.4 · χ² 3,959 / p <1e-300 | 188.1 EB05 125.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.0 | no trial data cached |
| Psoriatic arthropathy | 64 | 225.8 187.7–271.7ROR 397.1 · χ² 14,105 / p <1e-300 | 211.3 EB05 171.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 180.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Therapeutic product effect decreased | 63 | 201.4 167.0–242.9ROR 349.9 · χ² 12,371 / p <1e-300 | 189.6 EB05 153.5 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 252.5 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 13 | 192.7 114.6–324.1ROR 211.2 · χ² 2,290 / p <1e-300 | 150.4 EB05 93.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.1 | no trial data cached |
| Bursitis | 16 | 188.1 118.4–298.9ROR 210.8 · χ² 2,792 / p <1e-300 | 153.8 EB05 100.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.6 | no trial data cached |
| Obesity | 18 | 160.0 103.7–246.8ROR 182.0 · χ² 2,686 / p <1e-300 | 136.9 EB05 91.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 118.0 | no trial data cached |
| Helicobacter infection | 11 | 153.0 86.6–270.3ROR 165.2 · χ² 1,512 / p <1e-300 | 121.3 EB05 72.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.7 | no trial data cached |
| Coeliac disease | 10 | 144.5 79.4–262.9ROR 154.9 · χ² 1,284 / p 2e-281 | 113.6 EB05 66.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.3 | no trial data cached |
| Taste disorder | 20 | 141.5 94.1–212.8ROR 163.5 · χ² 2,652 / p <1e-300 | 124.8 EB05 85.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 180.6 · 95% clinician | no trial data cached |
| Ill-defined disorder | 60 | 140.0 115.1–170.1ROR 234.7 · χ² 8,156 / p <1e-300 | 133.9 EB05 107.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.1 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Folliculitis | 10 | 137.3 75.4–249.8ROR 147.1 · χ² 1,219 / p 2e-267 | 109.2 EB05 63.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.5 | no trial data cached |
| Injection site reaction | 62 | 128.1 106.0–154.9ROR 219.8 · χ² 7,712 / p <1e-300 | 123.2 EB05 99.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 420.9 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Joint range of motion decreased | 12 | 127.3 74.0–219.0ROR 138.4 · χ² 1,380 / p <1e-300 | 106.2 EB05 64.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 103.1 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 59 | 126.7 103.9–154.4ROR 210.0 · χ² 7,247 / p <1e-300 | 121.6 EB05 97.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.5 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Sleep disorder | 61 | 123.6 102.0–149.9ROR 209.6 · χ² 7,315 / p <1e-300 | 119.0 EB05 96.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Therapeutic product effect incomplete | 61 | 122.3 100.9–148.3ROR 207.4 · χ² 7,238 / p <1e-300 | 117.8 EB05 95.0 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 146.2 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Treatment failure | 64 | 110.6 91.9–133.0ROR 194.0 · χ² 6,861 / p <1e-300 | 107.0 EB05 86.8 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 135.0 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Underdose | 49 | 95.1 75.6–119.6ROR 141.6 · χ² 4,480 / p <1e-300 | 91.7 EB05 72.1 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 230.0 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Intentional product use issue | 57 | 91.9 75.0–112.6ROR 148.8 · χ² 5,051 / p <1e-300 | 89.2 EB05 71.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 85.9 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Swelling | 58 | 88.1 72.0–107.6ROR 144.1 · χ² 4,924 / p <1e-300 | 85.6 EB05 68.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.8 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Gait inability | 20 | 85.7 57.0–128.8ROR 98.9 · χ² 1,591 / p <1e-300 | 79.3 EB05 54.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.7 | no trial data cached |
| Epilepsy | 17 | 79.0 50.5–123.5ROR 89.1 · χ² 1,233 / p 2e-270 | 72.7 EB05 48.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.5 | no trial data cached |
| Rheumatoid arthritis | 62 | 77.7 64.3–94.0ROR 133.0 · χ² 4,642 / p <1e-300 | 75.9 EB05 61.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.4 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Fibromyalgia | 13 | 75.9 45.1–127.5ROR 83.1 · χ² 888 / p 2e-195 | 68.5 EB05 42.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.4 | no trial data cached |
| Liver injury | 12 | 70.3 40.9–121.0ROR 76.5 · χ² 753 / p 5e-166 | 63.5 EB05 38.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.4 | no trial data cached |
| Incorrect product administration duration | 10 | 69.8 38.4–127.1ROR 74.8 · χ² 612 / p 2e-135 | 62.0 EB05 36.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Irritable bowel syndrome | 10 | 66.3 36.5–120.7ROR 71.1 · χ² 580 / p 2e-128 | 59.2 EB05 34.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.5 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 10 | 63.4 34.8–115.4ROR 67.9 · χ² 554 / p 1e-122 | 56.9 EB05 33.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.3 | no trial data cached |
| Hepatitis (liver inflammation) | 11 | 60.9 34.5–107.6ROR 65.7 · χ² 590 / p 1e-130 | 55.4 EB05 33.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.4 | no trial data cached |
| Overdose | 54 | 35.3 28.6–43.7ROR 55.0 · χ² 1,785 / p <1e-300 | 34.9 EB05 27.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 28.3 · ♀ 100% (drug 77%) · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 64 | 110.6 91.9–133.0ROR 194.0 · χ² 6,861 / p <1e-300 | 107.0 EB05 86.8 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 135.0 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Psoriatic arthropathy | 64 | 225.8 187.7–271.7ROR 397.1 · χ² 14,105 / p <1e-300 | 211.3 EB05 171.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 180.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Type 2 diabetes mellitus | 64 | 269.0 223.6–323.6ROR 473.2 · χ² 16,815 / p <1e-300 | 248.6 EB05 201.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.9 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Pericarditis | 64 | 546.2 453.8–657.3ROR 961.6 · χ² 34,179 / p <1e-300 | 467.6 EB05 379.1 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 348.7 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Therapeutic product effect decreased | 63 | 201.4 167.0–242.9ROR 349.9 · χ² 12,371 / p <1e-300 | 189.6 EB05 153.5 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 252.5 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Systemic lupus erythematosus | 63 | 252.8 209.6–304.9ROR 439.4 · χ² 15,545 / p <1e-300 | 234.4 EB05 189.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Wound | 63 | 321.8 266.7–388.1ROR 559.5 · χ² 19,806 / p <1e-300 | 292.5 EB05 236.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 243.1 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Pemphigus | 63 | 721.6 597.9–870.8ROR 1,255.7 · χ² 44,413 / p <1e-300 | 588.7 EB05 476.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 457.8 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Rheumatoid arthritis | 62 | 77.7 64.3–94.0ROR 133.0 · χ² 4,642 / p <1e-300 | 75.9 EB05 61.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.4 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Injection site reaction | 62 | 128.1 106.0–154.9ROR 219.8 · χ² 7,712 / p <1e-300 | 123.2 EB05 99.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 420.9 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Therapeutic product effect incomplete | 61 | 122.3 100.9–148.3ROR 207.4 · χ² 7,238 / p <1e-300 | 117.8 EB05 95.0 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 146.2 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Sleep disorder | 61 | 123.6 102.0–149.9ROR 209.6 · χ² 7,315 / p <1e-300 | 119.0 EB05 96.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.6 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| C-reactive protein increased | 61 | 238.0 196.3–288.6ROR 404.2 · χ² 14,163 / p <1e-300 | 221.2 EB05 178.4 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 157.3 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Ill-defined disorder | 60 | 140.0 115.1–170.1ROR 234.7 · χ² 8,156 / p <1e-300 | 133.9 EB05 107.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.1 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 59 | 126.7 103.9–154.4ROR 210.0 · χ² 7,247 / p <1e-300 | 121.6 EB05 97.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.5 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Diatrizoate Meglumine?
In FDA FAERS, the most frequently co-reported reaction terms for Diatrizoate Meglumine are psoriatic arthropathy, type 2 diabetes mellitus, pericarditis, systemic lupus erythematosus, wound, pemphigus. 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 Diatrizoate Meglumine have an FDA boxed warning?
No. The FDA label retrieved for Diatrizoate Meglumine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Diatrizoate Meglumine 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 7496d736-9f7d-4136-ad5d-b24c7803c21b, effective 20251123; matched on
openfda.generic_name.exact:"DIATRIZOATE MEGLUMINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 46 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.