What the label lists and what reports show
Iodixanol side effects
Iodixanol's FDA label: “Most common adverse reactions (incidence greater than 0.5%) in adult patients after VISIPAQUE injection: Discomfort, warmth, pain; Cardiovascular: angina.” FAERS holds 3,517 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (456 reports).
- Generic listed
- Boxed warning
Check it at the source: the iodixanol FDA label on DailyMed (effective October 10, 2025, GE Healthcare Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than 0.5%) in adult patients after VISIPAQUE injection: Discomfort, warmth, pain; Cardiovascular: angina.
TABLE 3 ADVERSE EVENTS REPORTED IN CONTROLLED CLINICAL TRIALS IN GREATER THAN 0.5% OF 1244 ADULT PATIENTS RECEIVING VISIPAQUE OR OTHER IODINATED CONTRAST AGENTS
| NUMBER OF PATIENTS EXPOSED | VISIPAQUE N (%) = 1244 | Pooled Comparators N (%) = 861 |
|---|---|---|
| Number of Patients with Any Adverse Event | 248 (19.9) | 194 (22.5) |
| Edema (any location) | 7 (0.6) | 0 (0) |
| Angina Pectoris/Chest Pain | 28 (2.2) | 22 (2.6) |
| Diarrhea | 7 (0.6) | 6 (0.7) |
| Nausea | 35 (2.8) | 32 (3.7) |
| Vomiting | 10 (0.8) | 11 (1.3) |
| Agitation, Anxiety, Insomnia, Nervousness | 10 (0.8) | 0 (0) |
| Dizziness | 8 (0.7) | 8 (0.9) |
| Headache/Migraine | 31 (2.5) | 15 (1.7) |
| Paresthesia | 12 (1.0) | 1 (0.1) |
| Sensory Disturbance | 10 (0.8) | 9 (1.0) |
| Syncope | 8 (0.6) | 1 (0.1) |
| Vertigo | 30 (2.4) | 20 (2.3) |
| Nonurticarial Rash or Erythema | 26 (2.1) | 4 (0.5) |
| Pruritus | 20 (1.6) | 3 (0.3) |
| Urticaria | 6 (0.5) | 10 (1.2) |
| Parosmia | 6 (0.5) | 4 (0.5) |
| Taste Perversion | 43 (3.5) | 32 (3.7) |
| Scotoma | 14 (1.1) | 2 (0.2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.3) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.4) ] Thromboembolic Events [see Warnings and Precautions (5.5) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence greater than 0.5%) in adult patients after VISIPAQUE injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. ( 6.1 ) Pediatric patients experienced similar adverse reactions. ( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, GE Healthcare Inc., effective October 10, 2025 (SPL set e9d87b8c-7695-4c0f-8e81-000dedb5f66d), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,517 reports list iodixanol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 271 are coded as a death and 1,420 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 25 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Iodixanol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions