What the label lists and what reports show
Indocyanine green and water side effects
Indocyanine green and water's FDA label: “The most common adverse reactions reported are anaphylaxis and urticaria.” FAERS holds 103 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 palpitations (10 reports).
- Generic listed
Check it at the source: the indocyanine green and water FDA label on DailyMed (effective April 13, 2025, Renew Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions reported are anaphylaxis and urticaria.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )]. The following adverse reactions have been identified during post-approval use of Indocyanine Green. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Renew Pharmaceuticals Limited, effective April 13, 2025 (SPL set a6f24787-c243-445a-9c55-7c7479b292d9), via openFDA; the full label on DailyMed
What do FAERS reports show?
103 reports list indocyanine green and water among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 24 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 22 reactions below, 1 is 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.
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?
- Indocyanine green and water: 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