Drug · FAERS side-effect profile with label screen
Ioversol side effects: what 3,821 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Optiray 320, Optiray 350
openFDA label
Who reports
3,821 reports · 75% serious · 232 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Art.
FDA label, Indications and Usage
Boxed warning
RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precuations ( 5.1 )].
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 40 strongest signals
Labeled — boxed warning 5Labeled adverse reaction 9Labeled (related wording) 6Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 17
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.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nephropathy toxic | 200 | 100.4 87.6–115.0ROR 105.9 · χ² 19,231 / p <1e-300 | 97.7 EB05 86.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 76.9 · ♀ 25% (drug 60%) · 99% clinician | no trial data cached |
| Sneezing | 208 | 51.5 45.1–58.8ROR 54.4 · χ² 10,170 / p <1e-300 | 50.8 EB05 45.3 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 47.7 · 96% clinician | no trial data cached |
| Anaphylactic shock | 174 | 37.5 32.4–43.4ROR 39.3 · χ² 6,114 / p <1e-300 | 37.1 EB05 32.7 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 28.7 · 95% clinician | no trial data cached |
| Throat tightness | 143 | 29.2 24.9–34.3ROR 30.3 · χ² 3,852 / p <1e-300 | 29.0 EB05 25.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.6 · 92% clinician | no trial data cached |
| Throat irritation | 215 | 26.5 23.3–30.2ROR 28.0 · χ² 5,240 / p <1e-300 | 26.3 EB05 23.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 94% clinician | no trial data cached |
| Pharyngeal oedema | 68 | 24.0 19.0–30.4ROR 24.5 · χ² 1,473 / p <1e-300 | 23.8 EB05 19.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · 91% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 53 | 20.4 15.6–26.7ROR 20.7 · χ² 955 / p 5e-210 | 20.2 EB05 16.0 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.3 · 94% clinician | no trial data cached |
| Eyelid oedema | 41 | 19.3 14.2–26.2ROR 19.5 · χ² 691 / p 1e-152 | 19.1 EB05 14.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · ♀ 82% (drug 60%) · 95% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 53 | 18.5 14.2–24.2ROR 18.8 · χ² 859 / p 5e-189 | 18.3 EB05 14.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 · 100% clinician | no trial data cached |
| Urticaria (hives) | 544 | 18.0 16.6–19.5ROR 20.8 · χ² 8,758 / p <1e-300 | 17.9 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 96% clinician | no trial data cached |
| Injection site extravasation | 38 | 16.8 12.2–23.0ROR 16.9 · χ² 546 / p 4e-121 | 16.5 EB05 12.5 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 81% (drug 60%) | no trial data cached |
| Shock | 66 | 15.9 12.5–20.2ROR 16.2 · χ² 906 / p 2e-199 | 15.8 EB05 12.8 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.1 · 100% clinician | no trial data cached |
| Paraesthesia oral | 37 | 14.2 10.3–19.5ROR 14.3 · χ² 439 / p 1e-97 | 13.9 EB05 10.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 97% clinician | no trial data cached |
| Eye pruritus | 81 | 13.5 10.9–16.8ROR 13.8 · χ² 926 / p 1e-203 | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.7 · 98% clinician | no trial data cached |
| Rash maculo-papular | 53 | 13.2 10.1–17.2ROR 13.3 · χ² 583 / p 5e-129 | 12.9 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · 96% clinician | no trial data cached |
| Hypoaesthesia oral | 34 | 12.4 8.9–17.4ROR 12.5 · χ² 345 / p 3e-77 | 12.0 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 80% (drug 60%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 24 | 11.9 7.9–17.7ROR 11.9 · χ² 227 / p 1e-51 | 11.1 EB05 7.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · ♀ 29% (drug 60%) · 100% clinician | no trial data cached |
| Face oedema | 36 | 11.7 8.4–16.2ROR 11.8 · χ² 341 / p 2e-76 | 11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 · ♀ 84% (drug 60%) · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 112 | 11.2 9.3–13.5ROR 11.5 · χ² 1,032 / p 9e-227 | 11.1 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.6 · 92% clinician | no trial data cached |
| Drug administration error | 62 | 11.0 8.6–14.0ROR 11.1 · χ² 551 / p 5e-122 | 10.7 EB05 8.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 20.0 | no trial data cached |
| Eosinophilia | 33 | 10.4 7.4–14.6ROR 10.5 · χ² 270 / p 5e-61 | 9.8 EB05 7.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · 97% clinician | no trial data cached |
| Eye swelling | 68 | 10.1 8.0–12.8ROR 10.3 · χ² 549 / p 9e-122 | 9.8 EB05 7.9 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 75 | 9.8 7.8–12.3ROR 10.0 · χ² 584 / p 3e-129 | 9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 90% clinician | no trial data cached |
| Nephropathy | 16 | 9.4 5.7–15.3ROR 9.4 · χ² 111 / p 3e-26 | 8.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Oxygen saturation decreased | 91 | 9.0 7.3–11.0ROR 9.2 · χ² 637 / p 9e-141 | 8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 · 93% clinician | no trial data cached |
| Chest discomfort | 162 | 8.7 7.5–10.2ROR 9.1 · χ² 1,105 / p 1e-242 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 98% clinician | no trial data cached |
| Lip swelling | 51 | 8.4 6.4–11.1ROR 8.5 · χ² 327 / p 2e-73 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · 96% clinician | no trial data cached |
| Swollen tongue | 47 | 8.3 6.2–11.0ROR 8.4 · χ² 293 / p 6e-66 | 7.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Pallor | 40 | 8.1 5.9–11.0ROR 8.1 · χ² 240 / p 2e-54 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 92% clinician | no trial data cached |
| Respiratory distress | 40 | 8.0 5.8–10.8ROR 8.0 · χ² 236 / p 1e-53 | 7.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 92% clinician | no trial data cached |
| Fear | 38 | 7.7 5.6–10.6ROR 7.8 · χ² 215 / p 5e-49 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Post procedural complication | 26 | 7.4 5.1–10.9ROR 7.5 · χ² 138 / p 3e-32 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 100% clinician | no trial data cached |
| Blood pressure decreased | 89 | 7.4 6.0–9.1ROR 7.5 · χ² 485 / p 9e-108 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 94% clinician | no trial data cached |
| Unresponsive to stimuli | 34 | 7.3 5.2–10.2ROR 7.3 · χ² 177 / p 9e-41 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 97% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 33 | 7.1 5.1–10.0ROR 7.1 · χ² 167 / p 2e-38 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · ♀ 83% (drug 60%) · 100% clinician | no trial data cached |
| Respiratory arrest | 35 | 6.9 5.0–9.6ROR 7.0 · χ² 171 / p 2e-39 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 · ♀ 39% (drug 60%) · 94% clinician | no trial data cached |
| Renal failure acute | 54 | 6.9 5.3–9.0ROR 7.0 · χ² 266 / p 3e-60 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 92% clinician | no trial data cached |
| Ocular hyperaemia | 58 | 6.8 5.3–8.8ROR 6.9 · χ² 283 / p 1e-63 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 95% clinician | no trial data cached |
| Wheezing | 73 | 6.8 5.4–8.5ROR 6.9 · χ² 355 / p 2e-79 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 90% clinician | no trial data cached |
| Pruritus generalised | 27 | 6.8 4.6–9.8ROR 6.8 · χ² 127 / p 1e-29 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · 96% 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 |
|---|---|---|---|---|---|---|
| Urticaria (hives) | 544 | 18.0 16.6–19.5ROR 20.8 · χ² 8,758 / p <1e-300 | 17.9 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 96% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 462 | 4.5 4.1–4.9ROR 5.0 · χ² 1,282 / p 5e-281 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 94% clinician | no trial data cached |
| Pruritus (itching) | 434 | 6.3 5.8–6.9ROR 7.0 · χ² 1,967 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 95% clinician | no trial data cached |
| Rash | 240 | 3.0 2.7–3.4ROR 3.2 · χ² 333 / p 1e-74 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 94% clinician | no trial data cached |
| Throat irritation | 215 | 26.5 23.3–30.2ROR 28.0 · χ² 5,240 / p <1e-300 | 26.3 EB05 23.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 94% clinician | no trial data cached |
| Sneezing | 208 | 51.5 45.1–58.8ROR 54.4 · χ² 10,170 / p <1e-300 | 50.8 EB05 45.3 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 47.7 · 96% clinician | no trial data cached |
| Erythema (skin redness) | 202 | 5.4 4.7–6.2ROR 5.7 · χ² 727 / p 2e-160 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | no trial data cached |
| Nephropathy toxic | 200 | 100.4 87.6–115.0ROR 105.9 · χ² 19,231 / p <1e-300 | 97.7 EB05 86.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 76.9 · ♀ 25% (drug 60%) · 99% clinician | no trial data cached |
| Cough | 191 | 3.7 3.3–4.3ROR 3.9 · χ² 387 / p 2e-86 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 93% clinician | no trial data cached |
| Anaphylactic shock | 174 | 37.5 32.4–43.4ROR 39.3 · χ² 6,114 / p <1e-300 | 37.1 EB05 32.7 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 28.7 · 95% clinician | no trial data cached |
| Chest discomfort | 162 | 8.7 7.5–10.2ROR 9.1 · χ² 1,105 / p 1e-242 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 98% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 145 | 4.3 3.7–5.0ROR 4.4 · χ² 366 / p 6e-82 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.4 · 93% clinician | no trial data cached |
| Throat tightness | 143 | 29.2 24.9–34.3ROR 30.3 · χ² 3,852 / p <1e-300 | 29.0 EB05 25.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.6 · 92% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 112 | 11.2 9.3–13.5ROR 11.5 · χ² 1,032 / p 9e-227 | 11.1 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.6 · 92% clinician | no trial data cached |
| Loss of consciousness | 103 | 4.4 3.6–5.3ROR 4.5 · χ² 270 / p 6e-61 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 93% 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.
- Nephropathy toxic — n=200, PRR 100.4
- Throat tightness — n=143, PRR 29.2
- Pharyngeal oedema — n=68, PRR 24.0
- Eyelid oedema — n=41, PRR 19.3
- Paraesthesia oral — n=37, PRR 14.2
- Rash maculo-papular — n=53, PRR 13.2
- Hypoaesthesia oral — n=34, PRR 12.4
- Cardio-respiratory arrest — n=75, PRR 9.8
- Chest discomfort — n=162, PRR 8.7
- Swollen tongue — n=47, PRR 8.3
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 Ioversol?
In FDA FAERS, the most frequently co-reported reaction terms for Ioversol are urticaria, dyspnoea, pruritus, rash, throat irritation, sneezing. 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 Ioversol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precuations ( 5.1 )].
Do FAERS signals prove that Ioversol 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 cd718d1c-f813-4114-a50d-c744ff7eb1bf, effective 20251229; matched on
openfda.generic_name.exact:"IOVERSOL") - 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.