What the label lists and what reports show
Iopromide side effects
Iopromide's FDA label lists its adverse reactions in its own words. FAERS holds 4,026 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 dyspnoea (598 reports).
- No generic listed
- Boxed warning
Check it at the source: the iopromide FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following adverse reactions are described elsewhere in the labeling: • Risks Associated with Intrathecal Use [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 to 3 Years of Age [see Warnings and Precautions ( 5.8 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Table 4: Adverse Reactions Reported in >1% of Patients Receiving ULTRAVIST in Clinical… ULTRAVIST N=1,142 (%) |
|---|---|
| Headache | 46 (4) |
| Abnormal Vision | 12 (1.1) |
| Chest pain | 18 (1.6) |
| Vasodilatation | 30 (2.6) |
| Nausea | 42 (3.7) |
| Back pain | 22 (1.9) |
| Urinary urgency | 21 (1.8) |
| Injection site and infusion site reactions (hemorrhage, hematoma, pain, edema, erythema,… | 41 (3.7) |
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.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set df917c3a-59a2-4ed1-8470-8a5394c73325), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,026 reports list iopromide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 330 are coded as a death and 1,317 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, 13 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?
- Iopromide: 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