Applies to defibrotide: intravenous solution.
Serious side effects of Defibrotide
Along with its needed effects, defibrotide 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
Other side effects of Defibrotide
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]
