INDOCYANINE GREEN: 89 Adverse Event Reports & Safety Profile
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89
Total FAERS Reports
2 (2.2%)
Deaths Reported
18
Hospitalizations
89
As Primary/Secondary Suspect
11
Life-Threatening
4
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Prescription
Status
Yes
Generic Available
FDA Application: 011525 ·
Patent Expires: Jun 4, 2028 · First Report: 20140113 · Latest Report: 20250718
What Are the Most Common INDOCYANINE GREEN Side Effects?
#1 Most Reported
Patent ductus arteriosus
11 reports (12.4%)
#2 Most Reported
Low birth weight baby
11 reports (12.4%)
#3 Most Reported
Haemangioma congenital
11 reports (12.4%)
All INDOCYANINE GREEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Haemangioma congenital | 11 | 12.4% | 0 | 0 |
| Low birth weight baby | 11 | 12.4% | 0 | 0 |
| Patent ductus arteriosus | 11 | 12.4% | 0 | 0 |
| Anaphylactic reaction | 7 | 7.9% | 0 | 3 |
| Anaphylactic shock | 7 | 7.9% | 0 | 1 |
| Urticaria | 7 | 7.9% | 0 | 0 |
| Pruritus | 6 | 6.7% | 0 | 2 |
| Rash | 6 | 6.7% | 0 | 0 |
| Contrast media allergy | 5 | 5.6% | 0 | 0 |
| Liver function test increased | 5 | 5.6% | 0 | 5 |
| Nausea | 5 | 5.6% | 0 | 0 |
| Off label use | 5 | 5.6% | 0 | 0 |
| Thrombocytopenia | 5 | 5.6% | 0 | 5 |
| Visual acuity reduced | 5 | 5.6% | 0 | 0 |
Who Reports INDOCYANINE GREEN Side Effects? Age & Gender Data
Gender: 70.7% female, 29.3% male. Average age: 54.6 years. Most reports from: US. View detailed demographics →
Is INDOCYANINE GREEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 6 | 0 | 2 |
| 2015 | 4 | 0 | 0 |
| 2016 | 7 | 0 | 7 |
| 2017 | 17 | 0 | 0 |
| 2018 | 8 | 0 | 2 |
| 2019 | 4 | 0 | 1 |
| 2020 | 3 | 1 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 4 | 0 | 1 |
| 2024 | 7 | 0 | 2 |
| 2025 | 3 | 0 | 0 |
What Is INDOCYANINE GREEN Used For?
| Indication | Reports |
|---|---|
| Angiogram | 21 |
| Product used for unknown indication | 11 |
| Vitrectomy | 8 |
| Angiogram retina | 7 |
Official FDA Label for INDOCYANINE GREEN
Official prescribing information from the FDA-approved drug label.