ICODEXTRIN: 253 Adverse Event Reports & Safety Profile
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253
Total FAERS Reports
70 (27.7%)
Deaths Reported
147
Hospitalizations
253
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
Dec 20, 2002
FDA Approved
Prescription
Status
FDA Application: 021321 ·
First Report: 2012 · Latest Report: 20250825
What Are the Most Common ICODEXTRIN Side Effects?
#1 Most Reported
Peritonitis bacterial
51 reports (20.2%)
#2 Most Reported
Peritonitis
29 reports (11.5%)
#3 Most Reported
Death
26 reports (10.3%)
All ICODEXTRIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Peritonitis bacterial | 51 | 20.2% | 1 | 28 |
| Peritonitis | 29 | 11.5% | 4 | 19 |
| Death | 26 | 10.3% | 26 | 3 |
| Cerebrovascular accident | 16 | 6.3% | 13 | 14 |
| Pemphigoid | 13 | 5.1% | 2 | 7 |
| Hypotension | 10 | 4.0% | 1 | 9 |
| Chronic kidney disease-mineral and bone disorder | 9 | 3.6% | 0 | 0 |
| Fungal peritonitis | 9 | 3.6% | 0 | 8 |
| Hyponatraemia | 9 | 3.6% | 1 | 5 |
| Off label use | 9 | 3.6% | 1 | 3 |
| Therapeutic response decreased | 9 | 3.6% | 0 | 0 |
| Vomiting | 9 | 3.6% | 3 | 6 |
| Hypervolaemia | 8 | 3.2% | 0 | 8 |
| Pneumonia | 8 | 3.2% | 2 | 8 |
| Treatment noncompliance | 8 | 3.2% | 0 | 4 |
| Cardiac arrest | 6 | 2.4% | 6 | 3 |
| Hip fracture | 6 | 2.4% | 0 | 4 |
| Product use in unapproved indication | 6 | 2.4% | 0 | 0 |
| Sepsis | 6 | 2.4% | 6 | 5 |
| Cardiac failure congestive | 5 | 2.0% | 3 | 3 |
Who Reports ICODEXTRIN Side Effects? Age & Gender Data
Gender: 42.7% female, 57.3% male. Average age: 63.1 years. Most reports from: US. View detailed demographics →
Is ICODEXTRIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2013 | 7 | 2 | 1 |
| 2014 | 24 | 13 | 19 |
| 2015 | 9 | 5 | 1 |
| 2016 | 2 | 0 | 0 |
| 2017 | 16 | 12 | 13 |
| 2019 | 3 | 0 | 1 |
| 2020 | 4 | 1 | 1 |
| 2021 | 2 | 0 | 1 |
| 2022 | 5 | 0 | 1 |
| 2023 | 11 | 0 | 6 |
| 2024 | 20 | 4 | 14 |
| 2025 | 27 | 2 | 21 |
What Is ICODEXTRIN Used For?
| Indication | Reports |
|---|---|
| Peritoneal dialysis | 101 |
| End stage renal disease | 100 |
| Product used for unknown indication | 21 |
ICODEXTRIN vs Alternatives: Which Is Safer?
ICODEXTRIN vs ICOSAPENT
ICODEXTRIN vs ICOSAPENT ETHYL
ICODEXTRIN vs IDARUBICIN
ICODEXTRIN vs IDARUCIZUMAB
ICODEXTRIN vs IDECABTAGENE VICLEUCEL
ICODEXTRIN vs IDELALISIB
ICODEXTRIN vs IDURSULFASE
ICODEXTRIN vs IFOSFAMIDE
ICODEXTRIN vs IGURATIMOD
ICODEXTRIN vs ILOPERIDONE
Official FDA Label for ICODEXTRIN
Official prescribing information from the FDA-approved drug label.