What the label lists and what reports show
Ioversol side effects
Ioversol's FDA label: “The most common reaction is nausea, occurring at a rate of greater than 1 percent.” FAERS holds 3,821 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 urticaria (544 reports).
- No generic listed
- Boxed warning
Check it at the source: the ioversol FDA label on DailyMed (effective December 29, 2025, Liebel-Flarsheim Company LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common reaction is nausea, occurring at a rate of greater than 1 percent.
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 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 )] 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 ( 5.10 ) The most common reaction is nausea, occurring at a rate of greater than 1 percent. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIEBEL-FLARSHEIM COMPANY LLC at 855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Adult Patients 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. The following table shows reactions based upon clinical trials with OPTIRAY (ioversol) in 4,187 patients. Adverse reactions are listed by organ system according to clinical importance. …
Source: FDA drug label, Liebel-Flarsheim Company LLC, effective December 29, 2025 (SPL set 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,821 reports list ioversol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 232 are coded as a death and 1,005 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, 17 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?
- Ioversol: 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