Radiographic Contrast Agent side effects compared: 6 drugs, 23,820 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Iohexol | 8,244 | 80% | 488 | boxed | Urticaria; Contrast media reaction; Contrast media allergy | Sneezing; Rash maculo-papular |
| Iopromide (Ultravist) | 4,026 | 90% | 330 | boxed | Urticaria; Erythema; Blood pressure decreased | Anaphylactic shock; Sneezing |
| Ioversol (Optiray 320, Optiray 350) | 3,821 | 75% | 232 | boxed | Urticaria; Throat irritation; Sneezing | Nephropathy toxic; Chest discomfort |
| Iodixanol | 3,517 | 92% | 271 | boxed | Erythema; Urticaria; Anaphylactic reaction | Rash maculo-papular; Swelling face |
| Iopamidol (Isovue 200, Isovue 250) | 2,931 | 74% | 263 | boxed | Urticaria; Anaphylactic reaction; Acute kidney injury | Anaphylactic shock; Throat irritation |
| Ethiodized Oil (Lipiodol) | 1,281 | 97% | 152 | boxed | Pulmonary embolism; Aspartate aminotransferase increased; Hypothyroidism | Pancytopenia |
Class-wide signals (flagged in at least 3 of 6 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Sneezing | 5/6 | 34.0 | 1,063 | 3/5 members' labels |
| Anaphylactic shock | 5/6 | 22.1 | 912 | 3/5 members' labels |
| Urticaria | 5/6 | 15.5 | 2,484 | 5/5 members' labels |
| Drug reaction with eosinophilia and systemic symptoms | 5/6 | 14.0 | 261 | 5/5 members' labels |
| Nephropathy toxic | 4/6 | 42.0 | 399 | 0/4 members' labels |
| Rash maculo-papular | 4/6 | 17.1 | 399 | 0/4 members' labels |
| Cyanosis | 4/6 | 16.5 | 229 | 2/4 members' labels |
| Throat tightness | 4/6 | 16.0 | 455 | 2/4 members' labels |
| Anaphylactic reaction | 4/6 | 13.8 | 570 | 4/4 members' labels |
| Shock | 4/6 | 11.3 | 174 | 4/4 members' labels |
| Pharyngeal oedema | 4/6 | 10.7 | 142 | 2/4 members' labels |
| Ventricular fibrillation | 4/6 | 10.5 | 79 | 3/4 members' labels |
| Unresponsive to stimuli | 4/6 | 9.5 | 217 | 0/4 members' labels |
| Eyelid oedema | 3/6 | 24.6 | 188 | 0/3 members' labels |
| Face oedema | 3/6 | 19.8 | 185 | 2/3 members' labels |
| Tachypnoea | 3/6 | 15.1 | 193 | 0/3 members' labels |
| Bronchospasm | 3/6 | 13.9 | 115 | 3/3 members' labels |
| Hypoaesthesia oral | 3/6 | 12.4 | 92 | 0/3 members' labels |
| Eosinophilia | 3/6 | 11.9 | 147 | 3/3 members' labels |
| Cardio-respiratory arrest | 3/6 | 9.7 | 183 | 0/3 members' labels |
| Throat irritation | 3/6 | 9.6 | 353 | 1/3 members' labels |
| Angioedema | 3/6 | 8.4 | 170 | 3/3 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Contrast encephalopathy | Iohexol | 58 | 703.0 | Labeled (related wording) |
| Contrast media allergy | Iohexol | 247 | 407.2 | Labeled (related wording) |
| Contrast media reaction | Iohexol | 267 | 324.4 | Labeled adverse reaction |
| Extravasation | Iohexol | 133 | 84.4 | Labeled adverse reaction |
| Laryngeal oedema | Iohexol | 55 | 22.9 | Labeled adverse reaction |
| Urinary incontinence | Iopromide | 89 | 15.7 | Not in label — unassessed |
| Sensation of foreign body | Iohexol | 50 | 15.3 | Not in label — unassessed |
| Eye pruritus | Ioversol | 81 | 13.5 | Labeled (related wording) |
| Altered state of consciousness | Iopromide | 51 | 12.4 | Not in label — unassessed |
| Loss of consciousness | Iopromide | 252 | 10.3 | Labeled (related wording) |
| Eye swelling | Ioversol | 68 | 10.1 | Labeled (related wording) |
| Dysphonia | Iopromide | 111 | 9.9 | Not in label — unassessed |
| Swelling face | Iodixanol | 98 | 9.0 | Not in label — unassessed |
| Ocular hyperaemia | Ioversol | 58 | 6.8 | Not in label — unassessed |
| Wheezing | Ioversol | 73 | 6.8 | Not in label — unassessed |
| Cardiac arrest | Iopamidol | 71 | 6.1 | Labeled — boxed warning |
| Acute kidney injury | Iopamidol | 114 | 5.3 | Labeled — boxed warning |
Common questions
Which radiographic contrast agent has the most FDA adverse event reports?
Iohexol has the most FAERS co-reports in this class (8,244), followed by Iopromide (4,026). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across radiographic contrast agent drugs?
Reaction terms flagged in at least half of the 6 members include sneezing, anaphylactic shock, urticaria, drug reaction with eosinophilia and systemic symptoms, nephropathy toxic. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.