Iopamidol side effects: what 2,931 FDA adverse event reports show
Drug class
Brand names
Isovue 200, Isovue 250, Isovue 300, Isovue 370
Who reports
2,931 reports · 74% serious · 263 with death outcome · 59% female
Used for
ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac.
What it is
1.3 Oral Procedures † ISOVUE is indicated for: CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )].
Boxed warning
RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 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.
- 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. 77 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 |
|---|---|---|---|---|---|---|
| Anaphylactic reaction (severe allergic reaction) | 185 | 24.1 21.0–27.8ROR 25.7 · χ² 4,076 / p <1e-300 | 24.0 EB05 21.2 · IC025 +4.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 18.9 | no trial data cached |
| Anaphylactic shock | 79 | 22.1 17.8–27.5ROR 22.7 · χ² 1,566 / p <1e-300 | 21.9 EB05 18.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 · 92% clinician | no trial data cached |
| Sneezing | 62 | 19.9 15.5–25.4ROR 20.3 · χ² 1,089 / p 4e-239 | 19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.3 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 68 | 19.1 15.1–24.1ROR 19.5 · χ² 1,144 / p 6e-251 | 18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.9 · 100% clinician | no trial data cached |
| Product physical issue | 53 | 19.0 14.6–24.9ROR 19.4 · χ² 886 / p 5e-195 | 18.9 EB05 15.0 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | 98% clinician | no trial data cached |
| Nephropathy toxic | 27 | 17.4 11.9–25.3ROR 17.5 · χ² 399 / p 4e-89 | 17.0 EB05 12.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · 100% clinician | no trial data cached |
| Acute respiratory failure | 34 | 12.7 9.1–17.7ROR 12.8 · χ² 355 / p 2e-79 | 12.3 EB05 9.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 | no trial data cached |
| Throat tightness | 46 | 12.2 9.1–16.2ROR 12.4 · χ² 461 / p 2e-102 | 11.9 EB05 9.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · 93% clinician | no trial data cached |
| Unresponsive to stimuli | 41 | 11.4 8.4–15.5ROR 11.5 · χ² 378 / p 1e-84 | 11.0 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Pharyngeal oedema | 24 | 11.0 7.4–16.4ROR 11.1 · χ² 208 / p 2e-47 | 10.2 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 95% clinician | no trial data cached |
| Ventricular fibrillation | 16 | 10.3 6.3–16.8ROR 10.3 · χ² 125 / p 3e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Cardio-respiratory arrest | 57 | 9.7 7.5–12.5ROR 9.9 · χ² 435 / p 5e-97 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Throat irritation | 60 | 9.6 7.5–12.3ROR 9.8 · χ² 454 / p 5e-101 | 9.2 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Toxic skin eruption | 13 | 9.2 5.3–15.8ROR 9.2 · χ² 87 / p 6e-21 | 7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Hypoaesthesia oral | 19 | 9.0 5.8–14.1ROR 9.1 · χ² 128 / p 7e-30 | 7.9 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Urticaria (hives) | 187 | 8.0 7.0–9.2ROR 8.5 · χ² 1,152 / p 7e-253 | 7.9 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Urosepsis | 10 | 7.8 4.2–14.4ROR 7.8 · χ² 52 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Skin laceration | 11 | 7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Renal tubular necrosis | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Ischaemic stroke | 18 | 7.2 4.5–11.4ROR 7.2 · χ² 90 / p 1e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Injection site extravasation | 12 | 6.9 3.9–12.1ROR 6.9 · χ² 54 / p 8e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Incorrect route of product administration | 16 | 6.8 4.2–11.1ROR 6.8 · χ² 74 / p 5e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Clostridium difficile colitis | 10 | 6.7 3.6–12.5ROR 6.8 · χ² 43 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Respiratory arrest | 24 | 6.2 4.1–9.2ROR 6.2 · χ² 99 / p 1e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.9 · 95% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 71 | 6.1 4.9–7.7ROR 6.3 · χ² 300 / p 1e-67 | 5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 | no trial data cached |
| Paraesthesia oral | 12 | 6.0 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Multi-organ failure | 14 | 5.7 3.4–9.6ROR 5.7 · χ² 50 / p 9e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Contraindicated product administered | 24 | 5.7 3.8–8.5ROR 5.7 · χ² 88 / p 3e-21 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Brain oedema | 10 | 5.7 3.0–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.5 | no trial data cached |
| No adverse event | 140 | 5.6 4.8–6.6ROR 5.9 · χ² 534 / p 2e-118 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | 92% clinician | no trial data cached |
| Hiatus hernia | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 33 / p 6e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Hypoxia (low oxygen) | 27 | 5.5 3.8–8.0ROR 5.5 · χ² 95 / p 9e-23 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 5.4 3.1–9.6ROR 5.5 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 114 | 5.3 4.5–6.4ROR 5.5 · χ² 401 / p 1e-89 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 · 90% clinician | no trial data cached |
| Neurotoxicity | 13 | 5.3 3.1–9.2ROR 5.4 · χ² 42 / p 5e-11 | 4.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Oxygen saturation decreased | 41 | 5.3 3.9–7.1ROR 5.3 · χ² 137 / p 6e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 97% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 11 | 5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Maternal exposure during pregnancy | 64 | 5.2 4.1–6.6ROR 5.3 · χ² 213 / p 2e-48 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 0.3 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 31 | 5.0 3.5–7.1ROR 5.1 · χ² 96 / p 6e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.0 · ♀ 34% (drug 59%) · 90% clinician | no trial data cached |
| Shock | 16 | 5.0 3.1–8.2ROR 5.0 · χ² 47 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Urticaria (hives) | 187 | 8.0 7.0–9.2ROR 8.5 · χ² 1,152 / p 7e-253 | 7.9 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 185 | 24.1 21.0–27.8ROR 25.7 · χ² 4,076 / p <1e-300 | 24.0 EB05 21.2 · IC025 +4.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 18.9 | no trial data cached |
| Pruritus (itching) | 166 | 3.1 2.7–3.6ROR 3.3 · χ² 244 / p 3e-55 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| No adverse event | 140 | 5.6 4.8–6.6ROR 5.9 · χ² 534 / p 2e-118 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 114 | 5.3 4.5–6.4ROR 5.5 · χ² 401 / p 1e-89 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 · 90% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 106 | 4.1 3.4–4.9ROR 4.2 · χ² 246 / p 1e-55 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 | no trial data cached |
| Erythema (skin redness) | 81 | 2.8 2.3–3.5ROR 2.9 · χ² 94 / p 1e-22 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Anaphylactic shock | 79 | 22.1 17.8–27.5ROR 22.7 · χ² 1,566 / p <1e-300 | 21.9 EB05 18.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 · 92% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 71 | 6.1 4.9–7.7ROR 6.3 · χ² 300 / p 1e-67 | 5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 68 | 19.1 15.1–24.1ROR 19.5 · χ² 1,144 / p 6e-251 | 18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.9 · 100% clinician | no trial data cached |
| Maternal exposure during pregnancy | 64 | 5.2 4.1–6.6ROR 5.3 · χ² 213 / p 2e-48 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 0.3 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Sneezing | 62 | 19.9 15.5–25.4ROR 20.3 · χ² 1,089 / p 4e-239 | 19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.3 | no trial data cached |
| Throat irritation | 60 | 9.6 7.5–12.3ROR 9.8 · χ² 454 / p 5e-101 | 9.2 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Cardio-respiratory arrest | 57 | 9.7 7.5–12.5ROR 9.9 · χ² 435 / p 5e-97 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Product physical issue | 53 | 19.0 14.6–24.9ROR 19.4 · χ² 886 / p 5e-195 | 18.9 EB05 15.0 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | 98% 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.
- Anaphylactic shock — n=79, PRR 22.1
- Nephropathy toxic — n=27, PRR 17.4
- Unresponsive to stimuli — n=41, PRR 11.4
- Pharyngeal oedema — n=24, PRR 11.0
- Cardio-respiratory arrest — n=57, PRR 9.7
- Throat irritation — n=60, PRR 9.6
- Hypoxia — n=27, PRR 5.5
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 Iopamidol?
In FDA FAERS, the most frequently co-reported reaction terms for Iopamidol are urticaria, anaphylactic reaction, pruritus, acute kidney injury, hypersensitivity, erythema. 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 Iopamidol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )].
Do FAERS signals prove that Iopamidol 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 ae8c18c9-3e7d-4515-b980-120025a88fc1, effective 20260310; matched on
openfda.generic_name.exact:"IOPAMIDOL") - 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, 117 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.