What the label lists and what reports show
Gadodiamide side effects
Gadodiamide's FDA label lists its adverse reactions in its own words. FAERS holds 3,355 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 nephrogenic systemic fibrosis (2,225 reports).
- No generic listed
- Boxed warning
Check it at the source: the gadodiamide FDA label on DailyMed (effective April 18, 2025, GE Healthcare Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of OMNISCAN?See " What is the most important information I should know about OMNISCAN? " Allergic reactions. OMNISCAN can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of OMNISCAN include: nausea, headache, and dizziness. These are not all the possible side effects of OMNISCAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, GE Healthcare Inc., effective April 18, 2025 (SPL set 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Acute Renal Failure [see Warnings and Precautions (5.5) ] The most frequent adverse reactions (≤ 3%) observed during OMNISCAN adult clinical studies were nausea, headache, and dizziness ( 6.1 ) Serious or life-threatening reactions include: cardiac failure, arrhythmia and myocardial infarction ( 6.1 , 6.2 ) 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 April 18, 2025 (SPL set 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,355 reports list gadodiamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 373 are coded as a death and 313 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, 8 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?
- Gadodiamide: 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