Defibrotide: uses, dosing, side effects & brands
Defibrotide is a medicine sold in the U.S. under one brand, for hepatic veno-occlusive disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Hepatic Veno-Occlusive Disease
- Available as
- Injectable
- Sold as
- Defitelio
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How defibrotide is dosed
From the FDA label for Defitelio (application NDA208114). Other defibrotide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer DEFITELIO 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion. ( 2.1 ) • Treat for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of DEFITELIO for adult and pediatric patients is 6.25 mg/kg every 6 hours given as a 2‑hour intravenous infusion. The dose should be based on patient’s baseline body weight, defined as the patient’s weight prior to the preparative regimen for HSCT. Administer DEFITELIO for a minimum of 21 days. If after 21 days signs and symptoms of hepatic VOD have not resolved, continue DEFITELIO until resolution of VOD or up to a maximum of 60 days. 2.2 Administration Instructions • DEFITELIO must be diluted prior to infusion [see Dosage and Administration (2.4) ] . • Prior to administration of DEFITELIO, confirm that the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor [see Warnings and Precautions (5.1) ] . • Administer DEFITELIO by constant intravenous infusion over a 2-hour period. • Administer the diluted DEFITELIO solution using an infusion set equipped with a 0.2 micron in-line filter. Flush the intravenous administration line (peripheral or central) with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP immediately…
Defibrotide side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence ≥10% and independent of causality) with DEFITELIO treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of DEFITELIO was determined in 176 adult and pediatric patients with hepatic VOD with pulmonary and/or renal dysfunction following HSCT who were treated with DEFITELIO 6.25 mg/kg every 6 hours [see Clinical Studies (14) ] . Patients were excluded from these trials if at time of study entry they had significant acute bleeding, active grades B-D graft-versus-host disease, or a requirement for multiple vasopressors to provide blood pressure support. For the purposes of adverse event recording in the clinical trials, events were not required to be reported…
Who shouldn’t take defibrotide
The use of DEFITELIO is contraindicated in the following conditions: • Concomitant administration with systemic anticoagulant or fibrinolytic therapy [see Warnings and Precautions (5.1) ] • Known hypersensitivity to DEFITELIO or to any of its excipients [see Warnings and Precautions (5.2) ] • Concomitant administration with systemic anticoagulant or fibrinolytic therapy. ( 4 ) • Known hypersensitivity to DEFITELIO or to any of its excipients. ( 4 )
Defibrotide drug interactions
Antithrombotic Agents DEFITELIO may enhance the pharmacodynamic activity of antithrombotic/fibrinolytic drugs such as heparin or alteplase. Concomitant use of DEFITELIO with antithrombotic or fibrinolytic drugs is contraindicated because of an increased risk of hemorrhage [see Contraindications (4) ] . • DEFITELIO may enhance the activity of antithrombotic/fibrinolytic drugs. ( 7 )
Every defibrotide product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Defitelio.
What people report to the FDA about defibrotide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 48 reports naming defibrotide, and the FDA flagged 73% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- altered state of consciousness9 reports
- hepatic failure9 reports
- aspergillus infection8 reports
- septic shock8 reports
- covid-197 reports
- ascites5 reports
- venoocclusive liver disease5 reports
- haemorrhage4 reports
Read these as a signal, not a rate. A report does not mean defibrotide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is defibrotide?
Defibrotide sodium is an oligonucleotide mixture with profibrinolytic properties.
Can you take defibrotide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run defibrotide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does defibrotide come in?
Across the brands we track, defibrotide is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic defibrotide?
We do not currently list a generic-labelled defibrotide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Defibrotide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/defibrotide
- MLA
- “Defibrotide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/defibrotide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for defibrotide on DailyMed (NIH) ↗.