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Defitelio Side Effects

Generic Name: defibrotide

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

For the Consumer

Applies to defibrotide: intravenous solution

Along with its needed effects, defibrotide (the active ingredient contained in Defitelio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking defibrotide:

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

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

More Common

For Healthcare Professionals

Applies to defibrotide: intravenous solution

General

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]

Cardiovascular

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

Gastrointestinal

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]

Respiratory

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]

Immunologic

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]

Hematologic

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

Local

Common (1% to 10%): Catheter site hemorrhage

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

Metabolic

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

Genitourinary

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

Dermatologic

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

Ocular

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

Other

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

References

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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