Releuko Side Effects
Generic name: filgrastim
Medically reviewed by Drugs.com. Last updated on Mar 8, 2025.
Note: This document provides detailed information about Releuko Side Effects associated with filgrastim. Some dosage forms listed on this page may not apply specifically to the brand name Releuko.
Applies to filgrastim: solution.
Other dosage forms:
Serious side effects of Releuko
Along with its needed effects, filgrastim (the active ingredient contained in Releuko) 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 side effects
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chest pain or tightness
- chills
- confusion
- cough producing mucus
- dizziness
- fainting
- fever
- headache
- lightheadedness
- nervousness
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- slow or fast heartbeat
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- blisters on the skin
- cloudy urine
- cough or hoarseness
- coughing or spitting up blood
- decrease or increase in the amount of urine
- difficulty swallowing
- feeling of fullness
- general feeling of illness
- hives, itching, skin rash
- lower back or side pain
- nausea
- painful or difficult urination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sores on the skin
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- swollen glands
Other side effects of Releuko
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 side effects
- back pain
- bloody nose
- bone pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased appetite
- diarrhea
- difficulty with moving
- dizziness
- frequent urge to urinate
- hair loss or thinning of the hair
- muscle pain or stiffness
- pain in the arms, legs, or joints
- rash
- trouble sleeping
For healthcare professionals
Applies to filgrastim: injectable solution.
Hematologic adverse events
- 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]
References
1. (2002) "Product Information. Neupogen (filgrastim)." Amgen
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. (2018) "Product Information. Nivestym (filgrastim)." Pfizer U.S. Pharmaceuticals Group
5. (2018) "Product Information. Zarxio (filgrastim)." Sandoz Inc
Frequently asked questions
- What are biosimilar drugs and how do they compare to biologics?
- What biosimilars have been approved in the United States?
- What is the difference between Nivestym and Neupogen?
More about Releuko (filgrastim)
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Further information
Releuko side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.