Udenyca Side Effects
Generic name: pegfilgrastim
Note: This document provides detailed information about Udenyca Side Effects associated with pegfilgrastim. Some dosage forms listed on this page may not apply specifically to the brand name Udenyca.
Applies to pegfilgrastim: subcutaneous solution.
Serious side effects of Udenyca
Along with its needed effects, pegfilgrastim (the active ingredient contained in Udenyca) 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 pegfilgrastim:
More common
- chills
- cough
- fever
- sore throat
- ulcers, sores, or white spots in the mouth
Rare
- bluish lips or skin
- pain, left upper abdomen or shoulder
- tightness in the chest
- trouble breathing
Incidence not known
- black, tarry stools
- 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
- blisters in the skin
- blood in the urine or stools
- chest pain
- cloudy urine
- decrease in how much or how often you urinate
- difficulty with swallowing
- dizziness
- fainting or lightheadedness
- fast heartbeat
- flushing or redness of the skin
- hives or welts, skin rash
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- nausea
- painful or difficult urination
- pinpoint red spots on the skin
- sores on the skin
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusually warm skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking pegfilgrastim:
Symptoms of overdose
- bone pain
- chest pain
- difficult or labored breathing
- eye pain
- general feeling of illness
- headache
Other side effects of Udenyca
Some side effects of pegfilgrastim 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
- belching
- change in sense of taste
- constipation
- cracked lips
- diarrhea
- hair loss or thinning of the hair
- heartburn
- indigestion
- joint pain
- lack or loss of strength
- loss of appetite
- muscle soreness
- swelling or inflammation of the mouth
- trouble sleeping
- vomiting
- weakness, generalized
- weight loss
Incidence not known
- body produces substance that can bind to drug making it less effective or cause side effects
For healthcare professionals
Applies to pegfilgrastim: subcutaneous solution.
General
The most commonly reported side effects included bone pain, skeletal pain, medullary bone pain, and spontaneously reversible mild to moderate lactate dehydrogenase elevations.[Ref]
Musculoskeletal
- Very common (10% or more): Bone pain (up to 31%), skeletal pain (up to 27%), medullary bone pain (up to 26%)
- Common (1% to 10%): Arthralgia, back pain, extremity pain, limb pain, musculoskeletal pain, myalgia, neck pain, polyarthralgia, polymyalgia[Ref]
Metabolic
- Very common (10% or more): Spontaneously reversible mild to moderate lactate dehydrogenase elevations (up to 18%), spontaneously reversible mild to moderate alkaline phosphatase elevations (up to 11%), spontaneously reversible mild to moderate uric acid elevations (up to 11%)
- Common (1% to 10%): Spontaneously reversible severe uric acid elevations
- Frequency not reported: Anorexia[Ref]
Other
- Common (1% to 10%): Fever, non-cardiac chest pain, pain, pyrexia
- Frequency not reported: Fatigue, generalized weakness, mucositis[Ref]
Dermatologic
- Common (1% to 10%): Alopecia, contact dermatitis
- Uncommon (0.1% to 1%): Acute febrile dermatosis, cutaneous vasculitis, erythema/generalized erythema, pruritus, skin rash, Sweet's syndrome, urticaria[Ref]
Hematologic
- Common (1% to 10%): Leukocytosis, thrombocytopenia
- Uncommon (0.1% to 1%): Asymptomatic splenomegaly, fatal splenic rupture, sickle cell crisis, splenic rupture, splenomegaly/enlarged spleen
- Frequency not reported: Granulocytopenia, neutropenic fever[Ref]
Local
- Common (1% to 10%): Application site reactions, injection site pain
- Uncommon (0.1% to 1%): Injection site erythema, injection site reactions
- Postmarketing reports: Application site bruise, application site discomfort, application site hemorrhage, local skin reactions[Ref]
Gastrointestinal
- Common (1 to 10%): Diarrhea, nausea
- Frequency not reported: Abdominal pain, constipation, dyspepsia, stomatitis, vomiting[Ref]
Immunologic
Cardiovascular
- Common (1% to 10%): Chest pain
- Uncommon (0.1% to 1%): Capillary leak syndrome, flushing, hypotension
- Rare (0.01% to 0.1%): Aortitis
- Frequency not reported: Peripheral edema[Ref]
Nervous system
- Common (1% to 10%): Headache
- Frequency not reported: Dizziness, taste perversion[Ref]
Ocular
- Common (1% to 10%): Periorbital edema[Ref]
Respiratory
- Uncommon (0.1% to 1%): Acute respiratory distress syndrome (ARDS), dyspnea, fatal ARDS, interstitial pneumonia, pulmonary adverse reactions, pulmonary edema, pulmonary fibrosis, pulmonary infiltrates, respiratory failure[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Anaphylaxis, angioedema, hypersensitivity reactions/hypersensitivity-type reactions, serious allergic reactions
- Frequency not reported: Allergies to acrylics
- Postmarketing reports: Allergic reactions, allergic-type reactions, anaphylactic reactions[Ref]
Hepatic
- Uncommon (0.1% to 1%): Transient elevations in ALT, transient elevations in AST, transient elevations in liver function tests[Ref]
Renal
- Uncommon (0.1% to 1%): Glomerulonephritis[Ref]
Oncologic
- Frequency not reported: Potential for tumor growth stimulatory effects on malignant cells[Ref]
Psychiatric
- Frequency not reported: Insomnia[Ref]
References
1. (2002) "Product Information. Neulasta (pegfilgrastim)." Amgen
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
- What are biosimilar drugs and how do they compare to biologics?
- What is the difference between Udenyca and Neulasta?
- What is the difference between Udenyca and Fulphila?
- What does cbqv stand for in pegfilgrastim?
- How many biosimilars have been approved in the United States?
- What is the difference between Fulphila and Neulasta?
- How is Fulphila injected / administered?
- Is Fulphila a chemo drug?
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Further information
Udenyca 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.
Some side effects may not be reported. You may report them to the FDA.