Iodixanol side effects: what 3,517 FDA adverse event reports show
Drug class
Who reports
3,517 reports · 92% serious · 271 with death outcome · 48% female
Used for
Iodixanol injection is indicated in for: Iodixanol injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL).
Boxed warning
NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] .
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 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.
- 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. 96 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 |
|---|---|---|---|---|---|---|
| Rash maculo-papular | 114 | 30.8 25.7–37.0ROR 31.8 · χ² 3,248 / p <1e-300 | 30.5 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · 96% clinician | no trial data cached |
| Toxic skin eruption | 43 | 25.5 18.9–34.3ROR 25.8 · χ² 983 / p 4e-216 | 25.1 EB05 19.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 95% clinician | no trial data cached |
| Eosinophilia | 74 | 25.4 20.2–31.8ROR 25.9 · χ² 1,702 / p <1e-300 | 25.1 EB05 20.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 · 99% clinician | no trial data cached |
| Eyelid oedema | 48 | 24.6 18.5–32.5ROR 24.9 · χ² 1,057 / p 3e-232 | 24.3 EB05 19.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.5 · 100% clinician | no trial data cached |
| Nephropathy toxic | 40 | 21.5 15.8–29.3ROR 21.7 · χ² 759 / p 2e-167 | 21.2 EB05 16.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 24% (drug 48%) · 95% clinician | no trial data cached |
| Face oedema | 56 | 19.8 15.2–25.7ROR 20.1 · χ² 977 / p 9e-215 | 19.6 EB05 15.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 96% clinician | no trial data cached |
| Dermatitis allergic | 38 | 18.2 13.3–25.0ROR 18.4 · χ² 600 / p 7e-133 | 18.0 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 97% clinician | no trial data cached |
| Anaphylactic shock | 78 | 18.2 14.6–22.7ROR 18.6 · χ² 1,249 / p 8e-274 | 18.1 EB05 14.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · 99% clinician | no trial data cached |
| Renal tubular necrosis | 25 | 15.2 10.3–22.5ROR 15.3 · χ² 317 / p 4e-71 | 14.8 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 26% (drug 48%) · 92% clinician | no trial data cached |
| Renal failure acute | 104 | 14.4 11.9–17.5ROR 14.9 · χ² 1,287 / p 3e-282 | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 98% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 38 | 14.4 10.5–19.8ROR 14.6 · χ² 460 / p 2e-102 | 14.1 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 97% clinician | no trial data cached |
| Erythema multiforme | 22 | 14.1 9.3–21.4ROR 14.2 · χ² 254 / p 1e-57 | 13.5 EB05 9.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 100% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 60 | 14.0 10.9–18.0ROR 14.3 · χ² 713 / p 3e-157 | 13.9 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 · 97% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 125 | 13.6 11.4–16.2ROR 14.1 · χ² 1,447 / p <1e-300 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 98% clinician | no trial data cached |
| Nephropathy | 19 | 12.1 7.7–18.9ROR 12.2 · χ² 182 / p 8e-42 | 11.2 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Shock | 46 | 12.0 9.0–16.1ROR 12.2 · χ² 454 / p 4e-101 | 11.7 EB05 9.0 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.6 · 100% clinician | no trial data cached |
| Cardiogenic shock | 28 | 11.7 8.1–17.0ROR 11.8 · χ² 264 / p 1e-59 | 11.1 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 20% (drug 48%) · 96% clinician | no trial data cached |
| Hyperthyroidism | 28 | 11.6 8.0–16.7ROR 11.6 · χ² 259 / p 1e-58 | 10.9 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.8 · ♀ 78% (drug 48%) · 100% clinician | no trial data cached |
| Petechiae | 18 | 10.3 6.5–16.4ROR 10.4 · χ² 142 / p 4e-33 | 9.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Bronchospasm (airway tightening) | 24 | 10.0 6.7–14.9ROR 10.1 · χ² 186 / p 1e-42 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.9 · 100% clinician | no trial data cached |
| Cold sweat | 29 | 9.8 6.8–14.1ROR 9.9 · χ² 221 / p 3e-50 | 9.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 · 100% clinician | no trial data cached |
| Rash erythematous | 75 | 9.6 7.6–12.0ROR 9.7 · χ² 567 / p 1e-125 | 9.3 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 99% clinician | no trial data cached |
| Multi-organ failure | 28 | 9.5 6.6–13.8ROR 9.6 · χ² 205 / p 8e-47 | 8.8 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 68 | 9.2 7.3–11.6ROR 9.4 · χ² 489 / p 1e-108 | 8.9 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.8 · 99% clinician | no trial data cached |
| Swelling face | 98 | 9.0 7.4–10.9ROR 9.2 · χ² 690 / p 2e-152 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 98% clinician | no trial data cached |
| Tachypnoea | 20 | 8.8 5.7–13.7ROR 8.9 · χ² 131 / p 1e-30 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 95% clinician | no trial data cached |
| Fear | 40 | 8.8 6.5–12.0ROR 8.9 · χ² 269 / p 8e-61 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Drug eruption | 26 | 8.8 6.0–12.9ROR 8.9 · χ² 172 / p 1e-39 | 8.0 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Anhedonia | 39 | 8.8 6.4–12.0ROR 8.9 · χ² 262 / p 4e-59 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Ventricular fibrillation | 16 | 8.6 5.3–14.0ROR 8.6 · χ² 100 / p 9e-24 | 7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.4 | no trial data cached |
| Lactic acidosis | 45 | 8.4 6.3–11.2ROR 8.5 · χ² 285 / p 3e-64 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 70% (drug 48%) · 98% clinician | no trial data cached |
| Urticaria (hives) | 229 | 8.2 7.2–9.3ROR 8.7 · χ² 1,454 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 98% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 48 | 8.2 6.2–10.9ROR 8.3 · χ² 297 / p 8e-67 | 7.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 73% (drug 48%) · 96% clinician | no trial data cached |
| Sneezing | 30 | 8.0 5.6–11.4ROR 8.1 · χ² 177 / p 1e-40 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 100% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 20 | 7.9 5.1–12.3ROR 8.0 · χ² 114 / p 7e-27 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Erythema (skin redness) | 265 | 7.7 6.9–8.7ROR 8.3 · χ² 1,553 / p <1e-300 | 7.6 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 97% clinician | no trial data cached |
| Unresponsive to stimuli | 33 | 7.7 5.5–10.8ROR 7.7 · χ² 184 / p 3e-42 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Hepatic cytolysis | 15 | 7.3 4.4–12.1ROR 7.4 · χ² 76 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Pharyngeal oedema | 19 | 7.3 4.6–11.4ROR 7.3 · χ² 97 / p 4e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Cardio-respiratory arrest | 51 | 7.2 5.5–9.5ROR 7.3 · χ² 268 / p 2e-60 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 98% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Pruritus (itching) | 456 | 7.2 6.6–7.8ROR 8.1 · χ² 2,471 / p <1e-300 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 · 98% clinician | no trial data cached |
| Rash | 297 | 4.1 3.7–4.6ROR 4.4 · χ² 704 / p 3e-155 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 97% clinician | no trial data cached |
| Erythema (skin redness) | 265 | 7.7 6.9–8.7ROR 8.3 · χ² 1,553 / p <1e-300 | 7.6 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 97% clinician | no trial data cached |
| Urticaria (hives) | 229 | 8.2 7.2–9.3ROR 8.7 · χ² 1,454 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 98% clinician | no trial data cached |
| Hypotension (low blood pressure) | 156 | 4.6 4.0–5.4ROR 4.8 · χ² 447 / p 2e-99 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 100% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 143 | 5.6 4.8–6.6ROR 5.8 · χ² 540 / p 1e-119 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.4 · 98% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 125 | 13.6 11.4–16.2ROR 14.1 · χ² 1,447 / p <1e-300 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 98% clinician | no trial data cached |
| Rash maculo-papular | 114 | 30.8 25.7–37.0ROR 31.8 · χ² 3,248 / p <1e-300 | 30.5 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · 96% clinician | no trial data cached |
| Renal failure acute | 104 | 14.4 11.9–17.5ROR 14.9 · χ² 1,287 / p 3e-282 | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 98% clinician | no trial data cached |
| Chills | 99 | 5.0 4.1–6.1ROR 5.1 · χ² 317 / p 3e-71 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 100% clinician | no trial data cached |
| Swelling face | 98 | 9.0 7.4–10.9ROR 9.2 · χ² 690 / p 2e-152 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 98% clinician | no trial data cached |
| Renal failure (kidney failure) | 93 | 4.1 3.4–5.1ROR 4.2 · χ² 220 / p 4e-50 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 | no trial data cached |
| Flushing | 89 | 5.2 4.2–6.4ROR 5.3 · χ² 299 / p 3e-67 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 95% clinician | no trial data cached |
| Chest discomfort | 79 | 4.6 3.7–5.7ROR 4.7 · χ² 222 / p 2e-50 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 97% clinician | no trial data cached |
| Anaphylactic shock | 78 | 18.2 14.6–22.7ROR 18.6 · χ² 1,249 / p 8e-274 | 18.1 EB05 14.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · 99% clinician | 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.
- Rash maculo-papular — n=114, PRR 30.8
- Toxic skin eruption — n=43, PRR 25.5
- Eyelid oedema — n=48, PRR 24.6
- Nephropathy toxic — n=40, PRR 21.5
- Face oedema — n=56, PRR 19.8
- Dermatitis allergic — n=38, PRR 18.2
- Renal tubular necrosis — n=25, PRR 15.2
- Cyanosis — n=38, PRR 14.4
- Erythema multiforme — n=22, PRR 14.1
- Cardiogenic shock — n=28, PRR 11.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Iodixanol ↔ Contrast-induced nephropathy.
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 Iodixanol?
In FDA FAERS, the most frequently co-reported reaction terms for Iodixanol are pruritus, rash, erythema, urticaria, hypotension, acute kidney injury. 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 Iodixanol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] .
Do FAERS signals prove that Iodixanol 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 0fe89ea2-04f7-46c5-9c35-220d8c144a95, effective 20230721; matched on
openfda.generic_name.exact:"IODIXANOL") - 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, 136 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.