Note: This document contains side effect information about filgrastim. Some dosage forms listed on this page may not apply to the brand name Zarxio.
Applies to filgrastim: injection solution. Other dosage forms:
- solution
Serious side effects of Zarxio
Along with its needed effects, filgrastim (the active ingredient contained in Zarxio) 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 immediately if any of the following side effects occur while taking filgrastim:
More common
- Bleeding gums
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blood in the urine or stools
- bloody nose
- chills
- cough
- coughing up blood
- diarrhea
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- facial swelling
- feeling of fullness
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nausea
- nosebleeds
- pain in the back, ribs, arms, or legs
- pain spreading to the left shoulder
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red or purple spots on the skin
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain
- tightness in the chest
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- chest pain
- nervousness
- pounding in the ears
- slow or fast heartbeat
Incidence not known
- Blisters on the skin
- blue lips, fingernails, or skin
- difficult or fast breathing
- sores on the skin
- swollen glands
Other side effects of Zarxio
Some side effects of filgrastim 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
- Bone, joint, or muscle pain
- hair loss or thinning of the hair
- loss of appetite
- weight loss
Less common
- Cracked lips
- difficulty having a bowel movement
- swelling or inflammation of the mouth
For Healthcare Professionals
Applies to filgrastim: injectable solution.
Hematologic
Very common (10% or more): Decreased platelet counts (up to 97%), increase in white blood cell counts between 10 x 10(9)/L and 70 x 10(9)/L (up to 88%), decreased hemoglobin (up to 65%), mild to moderate decreases in hemoglobin (up to 59%), leukocytosis (up to 41%), thrombocytopenia (up to 38%), transient thrombocytopenia (up to 35%), palpable splenomegaly (up to 30%), splenomegaly (up to 30%), anemia (up to 10%)
Common (1% to 10%): Spleen disorder, splenic rupture/fatal splenic rupture
Uncommon (0.1% to 1%): Sickle cell anemia with crisis/sickle cell crisis
Rare (0.01% to 0.1%): Cytopenia
Postmarketing reports: Sickle cell disorders[Ref]
Musculoskeletal
Very common (10% or more): Mild to moderate musculoskeletal symptoms (up to 44%), medullary bone pain (up to 38%), mild to moderate bone pain (up to 33%), bone pain (up to 30%), back pain (up to 15%), musculoskeletal pain (up to 14%), flank pain (up to 12%), myalgia (up to 12%)
Common (1% to 10%): Arthralgia, extremity pain, muscle spasms, osteoporosis, severe musculoskeletal pain
Uncommon (0.1% to 1%): Pseudogout/chondrocalcinosis pyrophosphate, rheumatoid arthritis exacerbation
Rare (0.01% to 0.1%): Decreased bone density
Frequency not reported: Musculoskeletal chest pain, neck pain[Ref]
Other
Very common (10% or more): Pyrexia (up to 48%), fatigue (up to 20%), pain (up to 12%)
Common (1% to 10%): Asthenia, generalized weakness, malaise, mucosal inflammation, mucositis[Ref]
Respiratory
Very common (10% or more): Epistaxis (up to 15%), cough (up to 14%), dyspnea (up to 13%)
Common (1% to 10%): Bronchitis, hemoptysis, sore throat, upper respiratory tract infection
Uncommon (0.1% to 1%): Acute respiratory distress syndrome (ARDS), hypoxia, interstitial lung disease, pulmonary edema, pulmonary hemorrhage, pulmonary infiltrates/lung infiltration, respiratory failure
Very rare (less than 0.01%): Pulmonary adverse events
Frequency not reported: Interstitial pneumonia, serious pulmonary adverse events
Postmarketing reports: Alveolar hemorrhage[Ref]
Metabolic
Very common (10% or more): Spontaneously reversible elevations in lactate dehydrogenase (up to 56%), spontaneously reversible elevations in uric acid (up to 56%)
Common (1% to 10%): Anorexia, blood glucose decreased, blood lactate dehydrogenase increased, blood uric acid increased, decreased appetite, hyperuricemia
Uncommon (0.1% to 1%): Fluid volume disturbances[Ref]
Hepatic
Very common (10% or more): Spontaneously reversible elevations in alkaline phosphatase (up to 56%), blood alkaline phosphatase increased (up to 11%)
Common (1% to 10%): Gamma glutamyltransferase increased, hepatomegaly
Uncommon (0.1% to 1%): AST increased[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 43%), abdominal pain (up to 12%)
Common (1% to 10%): Constipation, diarrhea, oral pain, oropharyngeal pain, pharyngolaryngeal pain, vomiting
Frequency not reported: Stomatitis[Ref]
Nervous system
Very common (10% or more): Dizziness (up to 14%), headache (up to 10%)
Common (1% to 10%): Hypoesthesia, paresthesia[Ref]
Dermatologic
Very common (10% or more): Rash/skin rash (up to 14%)
Common (1% to 10%): Alopecia, cutaneous/leukocytoclastic vasculitis, erythema
Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis/Sweet's syndrome, maculopapular rash, pre-existing skin disorder exacerbation, psoriasis exacerbation
Frequency not reported: Urticaria[Ref]
Cardiovascular
Very common (10% or more): Chest pain (up to 13%)
Common (1% to 10%): Hypertension, hypotension, peripheral edema
Uncommon (0.1% to 1%): Capillary leak syndrome, veno-occlusive disease
Rare (0.01% to 0.1%): Aortitis, vascular disorder[Ref]
Genitourinary
Common (1% to 10%): Dysuria, hematuria, urinary tract infection
Uncommon (0.1% to 1%): Proteinuria,
Rare (0.01% to 0.1%): Urine abnormality[Ref]
Local
Common (1% to 10%): Injection site pain, injection site reaction, transfusion reaction[Ref]
Immunologic
Common (1% to 10%): Antibody formation, sepsis
Uncommon (0.1% to 1%): Graft versus Host Disease (GvHD)/fatal GvHD[Ref]
Hypersensitivity
Common (1% to 10%): Drug hypersensitivity
Uncommon (0.1% to 1%): Anaphylactic reaction, hypersensitivity/hypersensitivity reactions, severe allergic reaction
Very rare (less than 0.01%): Allergic reaction
Frequency not reported: Anaphylaxis, angioedema[Ref]
Renal
Common (1% to 10%): Glomerulonephritis[Ref]
Psychiatric
Common (1% to 10%): Insomnia[Ref]
Oncologic
Frequency not reported: cytogenetic abnormalities, transformation to myelodysplastic syndromes (MDS), transformation to acute myeloid leukemia (AML)[Ref]
Transformation to MDS/AML and cytogenetic abnormalities appeared to be confined to patients with congenital neutropenia. The cumulative risk in this population in the eighth year of treatment was predicted to be 16.5%, or approximately 2% per year.[Ref]