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Defitelio Side Effects

Generic Name: defibrotide

Note: This page contains information about the side effects of defibrotide. Some of the dosage forms included on this document may not apply to the brand name Defitelio.

For the Consumer

Applies to defibrotide: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by defibrotide (the active ingredient contained in Defitelio). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking defibrotide, check with your doctor or nurse immediately:

More common:
  • Black, tarry stools
  • bloody nose
  • bloody stools
  • blurred vision
  • chills
  • confusion
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • fever
  • lightheadedness
  • rapid, shallow breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
Less common:
  • Chest pain
  • cough or hoarseness
  • lower back or side pain
  • painful or difficult urination
  • sneezing
  • sore throat
  • tightness in the chest
  • troubled breathing
Less common or rare:
  • Difficulty with swallowing
  • hives, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known:
  • Bleeding gums
  • coughing up blood
  • headache
  • increased menstrual flow or vaginal bleeding
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine

Minor Side Effects

Some of the side effects that can occur with defibrotide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Diarrhea
  • nausea
  • vomiting

For Healthcare Professionals

Applies to defibrotide: intravenous solution


The most common adverse reactions were hypotension, diarrhea, vomiting, nausea, and epistaxis. The most common adverse reactions considered to be life-threatening or fatal were hypotension (7%) and pulmonary alveolar hemorrhage (7%). Hemorrhage events of any type and any grade were reported for 104 (59%) of the patients, and the events were considered life-threatening or fatal in 35 (20%).[Ref]


Very common (10% or more): Hypotension (37%)[Ref]


Very common (10% or more): Diarrhea (24%), vomiting (18%), nausea (16%)
Common (1% to 10%): Gastrointestinal hemorrhage
Uncommon (0.1% to 1%): Hematemesis, melena, mouth hemorrhage[Ref]


Very common (10% or more): Epistaxis (14%)
Common (1% to 10%): Pulmonary alveolar hemorrhage, lung infiltration, pneumonia, pulmonary hemorrhage
Uncommon (0.1% to 1%): Hemothorax[Ref]


Common (1% to 10%): Sepsis, graft versus host disease, infection
Uncommon (0.1% to 1%): Hypersensitivity, anaphylactic reaction[Ref]

Nervous system

Common (1% to 10%): Hemorrhage intracranial, cerebral hemorrhage
Uncommon (0.1% to 1%): Cerebral hematoma[Ref]


Common (1% to 10%): Coagulopathy, hemorrhage[Ref]


Common (1% to 10%): Catheter site hemorrhage
Uncommon (0.1% to 1%): Injection site hemorrhage[Ref]


Common (1% to 10%): Hyperuricemia[Ref]


Common (1% to 10%): Hematuria[Ref]


Uncommon (0.1% to 1%): Ecchymosis, petechiae, rash, pruritus[Ref]


Uncommon (0.1% to 1%): Conjunctival hemorrhage[Ref]


Uncommon (0.1% to 1%): Pyrexia[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Defitelio (defibrotide)." Jazz Pharmaceuticals, Palo Alto, CA.

Not all side effects for Defitelio may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.