Icodextrin
GET
/api/v1/drug/icodextrinMechanism of action
Sourced from openFDAMechanism-of-action class: Osmotic Activity.
Approval history
Sourced from openFDA- Dec 20, 2002NDANDA021321Vantive Us Hlthcare
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
30,672 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Death5,99720%
- 2Peritonitis1,8626.1%
- 3Peritoneal Dialysis Complication1,4704.8%
- 4Peritonitis Bacterial1,4674.8%
- 5Hypotension1,1703.8%
- 6Myocardial Infarction9713.2%
- 7Pneumonia9703.2%
- 8Infection7872.6%
- 9Sepsis7412.4%
- 10Fluid Overload7272.4%
- 11Fall7062.3%
- 12Dehydration6632.2%
- 13Asthenia6422.1%
- 14Dyspnoea6332.1%
- 15Abdominal Pain6312.1%
Literature
Recent PubMed references pinned to Icodextrin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Unexpected Reduction in Glucose Ultrafiltration Associated to a Continuously "Full Abdomen" Prescription After Introducing a Long Icodextrin Dwell: A Case Series.Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia · 2026 · Boni Brivio G, Santinello I, Cappelletti A, et al.PMID 42037289DOI 10.69097/43-01-2026-11
- Clinical benefits of icodextrin in peritoneal dialysis: Evidence from a multicenter, prospective, randomized controlled trial.The Journal of international medical research · 2025 · Li Y, Yang C, Zhou Z, et al.PMID 41027653DOI 10.1177/03000605251379205
- Estimating the costs and amount of recyclable polyvinyl chloride plastic waste associated with discarded Icodextrin.Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis · 2026 · Ghimire A, Shah M, Qirjazi E, et al.PMID 40421471DOI 10.1177/08968608251344074
- Bimodal solutions in peritoneal dialysis: what can we expect from different glucose volumes added to the icodextrin bag? Data from a simulation procedure.Journal of nephrology · 2025 · Davy A, Öberg CM, Boyer A, et al.PMID 40167986DOI 10.1007/s40620-025-02206-8
- Icodextrin versus Glucose 2.5% on markers of hypervolemia and survival of patients undergoing automated peritoneal dialysis with an unplanned start: a randomized controlled trial.Einstein (Sao Paulo, Brazil) · 2024 · Azevedo LS, Banin VB, Dias DB, et al.PMID 39661863DOI 10.31744/einstein_journal/2024AO0980
- Early Initiation of Icodextrin Reduces Peritoneal Dialysis-Associated Peritonitis Risk: A Retrospective Cohort Study.Blood purification · 2025 · Mitsuno R, Nakayama T, Morimoto K, et al.PMID 39647478DOI 10.1159/000542326
- Oxidative stress reduction by icodextrin-based glucose-free solutions in peritoneal dialysis: Support for new promising approaches.Artificial organs · 2024 · Basso A, Baldini P, Bertoldi G, et al.PMID 38822597DOI 10.1111/aor.14801
- Icodextrin-induced acute generalized exanthematous pustulosis in a patient with peritoneal dialysis.Nephrology (Carlton, Vic.) · 2024 · Liu CH, Chen CC, Sung CC, et al.PMID 38599621DOI 10.1111/nep.14302
Clinical trials
The 10 most recently updated of 46 ClinicalTrials.gov registrations naming Icodextrin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Observational Study of the Use of Extraneal in Peritoneal Dialysis in PatientsCompleted · Observational · 439 enrolled · Vantive Health LLCNCT06492031updated 2026-04-15
- Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.Recruiting · Phase 3 · Interventional · 170 enrolled · Iperboreal Pharma SrlNCT03994471updated 2026-03-24
- Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin ExchangeNot yet recruiting · Interventional · 10 enrolled · National University Health System, SingaporeNCT07168343updated 2026-01-21
- Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) PatientsCompleted · Phase 3 · Interventional · 71 enrolled · Vantive Health LLCNCT01219959updated 2025-07-24
- IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD PatientsCompleted · Phase 4 · Interventional · 137 enrolled · Vantive Health LLCNCT00567489updated 2025-07-22
- IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD PatientsCompleted · Phase 3 · Interventional · 43 enrolled · Vantive Health LLCNCT00567398updated 2025-07-22
- Heart Failure and Peritoneal UltrafiltrationTerminated · Phase 2 · Interventional · 12 enrolled · Vantive Health LLCNCT00368641updated 2025-07-15
- Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)Completed · Phase 2 · Interventional · 74 enrolled · St. Joseph's Healthcare HamiltonNCT01045980updated 2025-05-18
- PMCF Study for ADEPT® in LaparoscopicGynecologic SurgeryCompleted · Observational · 153 enrolled · Baxter Healthcare CorporationNCT05811585updated 2025-03-21
- Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IRWithdrawn · Phase 4 · Interventional · 0 enrolled · Vantive Health LLCNCT01093547updated 2025-03-13
Frequently asked questions
- How does Icodextrin work?
- Mechanism-of-action class: Osmotic Activity.
- What class of drug is Icodextrin?
- Icodextrin is classified as Osmotic Activity, Unknown Physiological Effect.
- What are the brand names for Icodextrin?
- Icodextrin is marketed under brand names including Extraneal.
Note. Data for
icodextrin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.