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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
  • 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

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
  • Diarrhea
  • nausea
  • vomiting

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.

Some side effects of Defitelio may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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. Drugs.com 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.

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