Iopromide side effects: what 4,026 FDA adverse event reports show
Drug class
Brand names
Ultravist
Who reports
4,026 reports · 90% serious · 330 with death outcome · 54% female
Used for
ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography a.
What it is
ULTRAVIST (iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration.
Boxed warning
NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
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.
- 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. 104 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 shock | 383 | 79.0 71.8–87.0ROR 87.2 · χ² 29,014 / p <1e-300 | 77.5 EB05 71.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 50.2 · 94% clinician | no trial data cached |
| Nephropathy toxic | 132 | 62.5 52.8–73.9ROR 64.5 · χ² 7,831 / p <1e-300 | 61.2 EB05 52.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 · 99% clinician | no trial data cached |
| Eyelid oedema | 99 | 44.4 36.5–54.0ROR 45.5 · χ² 4,125 / p <1e-300 | 43.7 EB05 36.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 41.0 · 95% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 126 | 42.0 35.3–49.9ROR 43.3 · χ² 4,961 / p <1e-300 | 41.4 EB05 35.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.3 | no trial data cached |
| Tachypnoea | 93 | 36.0 29.4–44.0ROR 36.8 · χ² 3,109 / p <1e-300 | 35.5 EB05 29.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 · 94% clinician | no trial data cached |
| Sneezing | 145 | 34.0 28.9–39.9ROR 35.2 · χ² 4,584 / p <1e-300 | 33.6 EB05 29.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 41.9 | no trial data cached |
| Blood pressure decreased | 372 | 29.4 26.7–32.4ROR 32.3 · χ² 10,142 / p <1e-300 | 29.2 EB05 26.8 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.8 · 94% clinician | no trial data cached |
| Face oedema | 93 | 28.7 23.5–35.2ROR 29.4 · χ² 2,451 / p <1e-300 | 28.4 EB05 23.9 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.8 · 98% clinician | no trial data cached |
| Unresponsive to stimuli | 109 | 22.2 18.4–26.7ROR 22.7 · χ² 2,174 / p <1e-300 | 22.0 EB05 18.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · 93% clinician | no trial data cached |
| Oxygen saturation decreased | 236 | 22.1 19.5–25.0ROR 23.4 · χ² 4,729 / p <1e-300 | 22.0 EB05 19.7 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 15.5 · 96% clinician | no trial data cached |
| Cold sweat | 61 | 18.1 14.1–23.2ROR 18.3 · χ² 964 / p 8e-212 | 17.9 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 · 95% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 84 | 17.2 13.9–21.2ROR 17.5 · χ² 1,261 / p 2e-276 | 17.1 EB05 14.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 · 100% clinician | no trial data cached |
| Pallor | 87 | 16.7 13.5–20.5ROR 17.0 · χ² 1,263 / p 7e-277 | 16.5 EB05 13.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · 97% clinician | no trial data cached |
| Urticaria (hives) | 518 | 16.3 15.0–17.6ROR 18.5 · χ² 7,439 / p <1e-300 | 16.2 EB05 15.1 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 | no trial data cached |
| Urinary incontinence | 89 | 15.7 12.8–19.3ROR 16.0 · χ² 1,208 / p 5e-265 | 15.6 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · 92% clinician | no trial data cached |
| Generalised oedema | 37 | 15.7 11.4–21.6ROR 15.8 · χ² 493 / p 1e-109 | 15.4 EB05 11.6 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 · ♀ 23% (drug 54%) · 95% clinician | no trial data cached |
| Rash maculo-papular | 62 | 14.6 11.4–18.7ROR 14.8 · χ² 771 / p 5e-170 | 14.4 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 93% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 148 | 14.1 12.0–16.5ROR 14.6 · χ² 1,783 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 9.1 · 95% clinician | no trial data cached |
| Hepatic encephalopathy | 25 | 14.0 9.4–20.7ROR 14.1 · χ² 288 / p 8e-65 | 13.5 EB05 9.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 0% (drug 54%) · 92% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 38 | 13.9 10.1–19.0ROR 14.0 · χ² 440 / p 6e-98 | 13.6 EB05 10.1 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.8 | no trial data cached |
| Hypoaesthesia oral | 39 | 13.5 9.9–18.5ROR 13.6 · χ² 439 / p 1e-97 | 13.2 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · 92% clinician | no trial data cached |
| Glomerular filtration rate decreased | 29 | 12.5 8.7–18.0ROR 12.6 · χ² 295 / p 2e-66 | 12.0 EB05 8.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 · ♀ 8% (drug 54%) · 93% clinician | no trial data cached |
| Altered state of consciousness | 51 | 12.4 9.4–16.2ROR 12.5 · χ² 520 / p 2e-115 | 12.1 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 94% clinician | no trial data cached |
| Peripheral coldness | 32 | 12.1 8.6–17.1ROR 12.2 · χ² 315 / p 9e-71 | 11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 97% clinician | no trial data cached |
| Eosinophilia | 40 | 11.9 8.8–16.3ROR 12.1 · χ² 390 / p 5e-87 | 11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · ♀ 24% (drug 54%) · 95% clinician | no trial data cached |
| Heart rate decreased | 78 | 11.5 9.3–14.4ROR 11.7 · χ² 740 / p 4e-163 | 11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 94% clinician | no trial data cached |
| Throat tightness | 58 | 11.2 8.7–14.5ROR 11.4 · χ² 528 / p 3e-117 | 10.9 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Ventricular fibrillation | 23 | 10.8 7.2–16.2ROR 10.8 · χ² 194 / p 2e-44 | 9.9 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Shock | 46 | 10.5 7.9–14.0ROR 10.6 · χ² 386 / p 3e-86 | 10.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.8 | no trial data cached |
| Pharyngeal oedema | 31 | 10.4 7.3–14.7ROR 10.4 · χ² 253 / p 3e-57 | 9.7 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Loss of consciousness | 252 | 10.3 9.1–11.6ROR 10.9 · χ² 2,104 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 91% clinician | no trial data cached |
| Lip swelling | 64 | 10.0 7.9–12.8ROR 10.2 · χ² 512 / p 1e-113 | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Rash erythematous | 90 | 10.0 8.2–12.3ROR 10.2 · χ² 722 / p 2e-159 | 9.8 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 94% clinician | no trial data cached |
| Dysphonia | 111 | 9.9 8.3–11.9ROR 10.2 · χ² 881 / p 5e-194 | 9.7 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 95% clinician | no trial data cached |
| Erythema (skin redness) | 381 | 9.7 8.8–10.7ROR 10.6 · χ² 2,982 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 92% clinician | no trial data cached |
| Blood pressure systolic increased | 36 | 9.6 6.9–13.3ROR 9.7 · χ² 268 / p 2e-60 | 9.0 EB05 6.6 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 · 100% clinician | no trial data cached |
| Temperature intolerance | 18 | 9.2 5.8–14.6ROR 9.2 · χ² 123 / p 6e-29 | 8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Throat irritation | 78 | 9.1 7.3–11.3ROR 9.3 · χ² 555 / p 6e-123 | 8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 75% (drug 54%) · 94% clinician | no trial data cached |
| Chest discomfort | 174 | 8.9 7.7–10.3ROR 9.3 · χ² 1,216 / p 1e-266 | 8.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 96% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 71 | 8.4 6.7–10.6ROR 8.5 · χ² 455 / p 3e-101 | 8.1 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · 90% 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 598 | 5.5 5.1–5.9ROR 6.3 · χ² 2,263 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Urticaria (hives) | 518 | 16.3 15.0–17.6ROR 18.5 · χ² 7,439 / p <1e-300 | 16.2 EB05 15.1 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 | no trial data cached |
| Pruritus (itching) | 458 | 6.3 5.8–6.9ROR 7.0 · χ² 2,080 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 92% clinician | no trial data cached |
| Anaphylactic shock | 383 | 79.0 71.8–87.0ROR 87.2 · χ² 29,014 / p <1e-300 | 77.5 EB05 71.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 50.2 · 94% clinician | no trial data cached |
| Erythema (skin redness) | 381 | 9.7 8.8–10.7ROR 10.6 · χ² 2,982 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 92% clinician | no trial data cached |
| Blood pressure decreased | 372 | 29.4 26.7–32.4ROR 32.3 · χ² 10,142 / p <1e-300 | 29.2 EB05 26.8 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.8 · 94% clinician | no trial data cached |
| Vomiting | 273 | 3.0 2.7–3.4ROR 3.2 · χ² 378 / p 1e-84 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 91% clinician | no trial data cached |
| Loss of consciousness | 252 | 10.3 9.1–11.6ROR 10.9 · χ² 2,104 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 91% clinician | no trial data cached |
| Oxygen saturation decreased | 236 | 22.1 19.5–25.0ROR 23.4 · χ² 4,729 / p <1e-300 | 22.0 EB05 19.7 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 15.5 · 96% clinician | no trial data cached |
| Rash | 222 | 2.7 2.3–3.0ROR 2.8 · χ² 234 / p 3e-53 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 188 | 4.9 4.3–5.6ROR 5.1 · χ² 583 / p 3e-129 | 4.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Chest discomfort | 174 | 8.9 7.7–10.3ROR 9.3 · χ² 1,216 / p 1e-266 | 8.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 96% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 169 | 6.8 5.9–7.9ROR 7.1 · χ² 840 / p 6e-185 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 96% clinician | no trial data cached |
| Cough | 163 | 3.0 2.6–3.5ROR 3.1 · χ² 223 / p 9e-51 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 148 | 14.1 12.0–16.5ROR 14.6 · χ² 1,783 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 9.1 · 95% 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=383, PRR 79.0
- Nephropathy toxic — n=132, PRR 62.5
- Eyelid oedema — n=99, PRR 44.4
- Cyanosis — n=126, PRR 42.0
- Tachypnoea — n=93, PRR 36.0
- Sneezing — n=145, PRR 34.0
- Unresponsive to stimuli — n=109, PRR 22.2
- Cold sweat — n=61, PRR 18.1
- Pallor — n=87, PRR 16.7
- Urinary incontinence — n=89, PRR 15.7
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 Iopromide?
In FDA FAERS, the most frequently co-reported reaction terms for Iopromide are dyspnoea, urticaria, pruritus, anaphylactic shock, erythema, blood pressure decreased. 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 Iopromide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Do FAERS signals prove that Iopromide 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 df917c3a-59a2-4ed1-8470-8a5394c73325, effective 20260302; matched on
openfda.generic_name.exact:"IOPROMIDE") - 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, 144 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.