What the label lists and what reports show
Iomeprol side effects
Iomeprol's FDA label: “Most common adverse reactions (incidence ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting.” FAERS holds 1,328 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 rash maculo-papular (218 reports).
- No generic listed
- Boxed warning
Check it at the source: the iomeprol FDA label on DailyMed (effective February 5, 2026, BRACCO DIAGNOSTICS INC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Table 5: Adverse Reactions Reported in ≥0.5% of 4,621 Adult Patients Receiving… Incidence (%) |
|---|---|
| Feeling hot | 2 |
| Headache | 1.2 |
| Nausea | 1 |
| Chest pain | 0.6 |
| Back pain | 0.5 |
| Vomiting | 0.5 |
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 Intrathecal Administration [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Acute 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 )] Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] Thyroid Dysfunction in Pediatric Patients 0 Years 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 ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, BRACCO DIAGNOSTICS INC, effective February 5, 2026 (SPL set cb2e0e00-7c93-0fb4-89a5-861641662a5a), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,328 reports list iomeprol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 823 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 24 reactions below, 18 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?
- Iomeprol: 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