PEG-Intron Side Effects

Please note - some side effects for PEG-Intron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of PEG-Intron - for the Consumer

PEG-Intron

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using PEG-Intron:

Diarrhea; dizziness; dry mouth or skin; hair thinning or loss; headache; joint pain; loss of appetite; mild stomach pain; muscle aches; nausea; temporary pain, redness, swelling, or itching at the injection site; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody stools or diarrhea; burning or painful urination; butterfly-shaped rash on the face; change in the amount of urine produced; chest, jaw, or arm pain; confusion; coughing up yellow or pink mucus; decreased hearing or hearing loss; fainting; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; hallucinations; loss of coordination; memory loss; mouth sores; new or worsening mental or mood problems (eg, aggression, anxiety, depression, exaggerated sense of well-being, irritability); numbness or weakness on one side of the body; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, light-headedness, or headache; severe or persistent joint or muscle pain; severe or persistent nausea or vomiting; severe or persistent stomach or back pain (with or without nausea and vomiting); shortness of breath; slurred speech; suicidal thoughts or actions; symptoms of new or worsening liver problems (eg, bloating of the stomach, dark urine, pale stools, persistent loss of appetite, unusual diarrhea or stomach pain, yellowing of the skin or eyes); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unexplained skin changes or weight changes); thoughts of hurting yourself or other people; unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness; vision loss or other vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: subcutaneous powder for injection

General

Nearly all study patients experienced one or more adverse events. The most common adverse effects associated with peginterferon alfa-2b (with or without ribavirin) for the treatment of chronic hepatitis C (CHC) have included headache, myalgia, fatigue/asthenia, injection site inflammation/reaction, emotional lability/irritability, nausea, rigors, and fevers. Serious adverse effects associated with peginterferon alfa-2b (with or without ribavirin) have been reported in approximately 12% of subjects during clinical trials. The most common serious adverse effects associated with peginterferon alfa-2b and ribavirin were depression and suicidal ideation in less than 1% of subjects. The most common fatal adverse effects associated with peginterferon alfa-2b and ribavirin were cardiac arrest, suicidal ideation, and suicide attempt in less than 1% of subjects. In most cases, adverse events resolved upon discontinuation of treatment. During clinical trials, 10% to 15% of CHC patients discontinued therapy due to adverse events.

The most common adverse effects associated with peginterferon alfa-2b for adjuvant treatment of melanoma have included fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reaction. The most common serious adverse effects were fatigue, increased ALT, increased AST, and pyrexia. During a clinical trial, 33% of melanoma patients discontinued therapy due to adverse events.

Hematologic

A 48-year-old patient with multiple myeloma experienced severe bone marrow hypoplasia coincident with peginterferon alfa-2b therapy. The patient had been receiving oral thalidomide during several months prior to adding peginterferon alfa-2b to her therapy, and she developed a severe bone marrow hypoplasia while she received these two drugs. Since she had received thalidomide therapy previously and this agent was never stopped, it would seem as if the peginterferon alfa-2b was responsible for the myelosuppression of the patient; however, the possibility of an interaction between thalidomide and interferon alfa-2b cannot be ruled out.

Hematologic side effects have included decreased neutrophil counts (70% alone, 85% with ribavirin), decreased hemoglobin levels (up to 47%), decreased platelet counts (20%), anemia (up to 35% with ribavirin), thrombocytopenia (7% alone, 5% with ribavirin), neutropenia (6% alone, up to 31% with ribavirin), and leukopenia (less than 1% alone, up to 10% with ribavirin) in CHC patients. Autoimmune thrombocytopenia with or without purpura (1% or less) and cases of severe potentially life-threatening neutropenia (1%) have been reported. Hyperbilirubinemia (10% to 14%) and hyperuricemia (33% to 38%), in association with hemolysis, have been reported during combination therapy trials using peginterferon alfa-2b with ribavirin. At least one case of severe bone marrow hypoplasia has been reported. Anemia (all grades: 6%; Grade 3/4: less than 1%) has been reported in melanoma patients. Pure red cell aplasia, idiopathic thrombocytopenic purpura, and thrombotic thrombocytopenic purpura have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (56% alone, up to 62% with ribavirin), dizziness (12% alone, up to 21% with ribavirin), hypertonia (5%), and agitation (2% alone, 8% with ribavirin) in CHC patients. Nerve palsy (facial, oculomotor), transient ischemic attack, and loss of consciousness have been reported in less than or equal to 1% of CHC patients. Headache (all grades: 70%; Grade 3/4: 4%), dysgeusia (all grades: 38%), dizziness (all grades: 35%; Grade 3/4: 2%), olfactory nerve disorder (all grades: 23%), and paresthesia (all grades: 21%; Grade 3/4: less than 1%) have been reported in melanoma patients. Vertigo, seizures, memory loss, migraine headache, paresthesia, hearing impairment, hearing loss, encephalopathy, and peripheral neuropathy have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included depression (29% alone, up to 31% with ribavirin), anxiety/emotional lability/irritability (28% alone, up to 47% with ribavirin), insomnia (23% alone, up to 41% with ribavirin), impaired concentration (10% alone, 17% with ribavirin), and nervousness (4% alone, 6% with ribavirin) in CHC patients. Life-threatening or fatal neuropsychiatric events including suicide, suicide attempt, suicidal and homicidal ideation, severe depression, psychosis, aggressive reaction, and relapse of drug addiction/overdose have been reported in less than or equal to 1% of CHC patients with and without a previous psychiatric disorder. Depression (all grades: 59%; Grade 3/4: 7%) has been reported in melanoma patients. Psychosis and hallucinations have been reported in patients treated with alpha interferons. Homicidal ideation, aggressive behavior, psychoses, hallucinations, bipolar disorders, and mania have been reported during postmarketing experience.

Other

Influenza-like symptoms may decrease in severity as treatment continues.

Other side effects have included fatigue/asthenia (52% alone, up to 68% with ribavirin), influenza-like symptoms (up to 46%), rigors (23% alone, 48% with ribavirin), fever (22% alone, up to 46% with ribavirin), chills (up to 39% with ribavirin), weight decrease (11% alone, up to 29% with ribavirin), unspecified pain (up to 13% with ribavirin), right upper quadrant pain (8% alone, 12% with ribavirin), malaise (7% alone, 4% with ribavirin), flushing (6% alone, 4% with ribavirin), and taste perversion (less than 1% alone, 9% with ribavirin) in CHC patients. Fatigue (all grades: 94%; Grade 3/4: 16%), pyrexia (all grades: 75%; Grade 3/4: 4%), chills (all grades: 63%; Grade 3/4: 1%), and decreased weight (all grades: 11%; Grade 3/4: less than 1%) have been reported in melanoma patients. Asthenic conditions (including asthenia, malaise, and fatigue) have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (54% alone, up to 56% with ribavirin), arthralgia (23% alone, up to 34% with ribavirin), and musculoskeletal pain (28% alone, 21% with ribavirin) in CHC patients. Gout and rheumatoid arthritis have been reported in less than or equal to 1% of CHC patients. Myalgia (all grades: 68%; Grade 3/4: 4%) and arthralgia (all grades: 51%; Grade 3/4: 3%) have been reported in melanoma patients. Rhabdomyolysis, myositis, and rheumatoid arthritis have been reported during postmarketing experience.

A small number of patients developed mild to moderate gout.

Local

Local side effects have included injection site inflammation/reaction, including bruise, itchiness, and irritation (47% alone, up to 75% with ribavirin); injection site pain (up to 3%); and injection site necrosis (1% or less) in CHC patients. Localized skin ulcerations have been reported after subcutaneous and intramuscular injection. Injection site reaction (all grades: 62%; Grade 3/4: 1.8%) has been reported in melanoma patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (26% alone, up to 43% with ribavirin), anorexia (20% alone, up to 32% with ribavirin), diarrhea (18% alone, up to 22% with ribavirin), abdominal pain (15% alone, up to 13% with ribavirin), vomiting (7% alone, up to 14% with ribavirin), dyspepsia (6% alone, 9% with ribavirin), dry mouth (6% alone, 12% with ribavirin), and constipation (1% alone, 5% with ribavirin) in CHC patients. Gastroenteritis and pancreatitis have been reported in less than or equal to 1% of CHC patients. Anorexia (all grades: 69%; Grade 3/4: 3%), nausea (all grades: 64%; Grade 3/4: 3%), diarrhea (all grades: 37%; Grade 3/4: 1%), and vomiting (all grades: 26%; Grade 3/4: 1%) have been reported in melanoma patients. Both fatal and nonfatal ulcerative colitis have been reported within the first three months of alpha interferon therapy. Pancreatitis, fatal and nonfatal, has also been reported with the use of alpha interferon therapy. Aphthous stomatitis, pancreatitis, and colitis have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included alopecia (22% alone, up to 36% with ribavirin), pruritus (12% alone, up to 29% with ribavirin), dry skin (11% alone, up to 24% with ribavirin), rash (6% alone, up to 34% with ribavirin), and increased sweating (6% alone, 11% with ribavirin) in CHC patients. Aggravated psoriasis, urticaria, and phototoxicity have been reported in less than or equal to 1% of CHC patients. At least one case of generalized exfoliative dermatitis has been reported. Exfoliative rash (all grades: 36%; Grade 3/4: 1%) and alopecia (all grades: 34%) have been reported in melanoma patients. Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, and psoriasis have been reported during postmarketing experience.

Urticaria and cutaneous desquamation of all of the patient's body except his face have been reported in a 41-year-old man with chronic hepatitis C infection after three months of combination antiviral treatment with peginterferon alfa-2b plus ribavirin. Initially, ribavirin was stopped and topical corticosteroid therapy started without significant improvement. Two weeks later peginterferon alfa-2b was discontinued and significant improvement (decrease in cutaneous lesions) was observed during the following week. Rechallenge with interferon alfa-2b confirmed the development of systemic cutaneous lesions and pruritus.

Immunologic

Immunologic side effects have included viral infections (11% alone, 12% with ribavirin), fungal infections (less than 1% alone, 6% with ribavirin), and exacerbation of autoimmune disorders in CHC patients. Lupus-like syndrome, sarcoidosis, and infection (sepsis, pneumonia, abscess, cellulitis) have been reported in less than or equal to 1% of CHC patients. Autoimmune thrombocytopenia has been reported four weeks after the start of treatment for hepatitis C. Autoimmune hepatitis and at least one case of Hashimoto encephalopathy have been reported. The development of binding antibodies (including neutralizing antibodies) to peginterferon alfa-2b has been reported. Bacterial infection (including sepsis) and systemic lupus erythematosus have been reported during postmarketing experience.

A case report of Hashimoto encephalopathy has been associated with the use of peginterferon alfa-2b with ribavirin for chronic hepatitis C infection in a 36-year-old woman with a 10-year history of autoimmune thyroiditis. Following discontinuation of the drugs, corticosteroid therapy was started and the patient experienced full recovery.

Cardiovascular

Cardiovascular side effects have included chest pain (6% alone, 8% with ribavirin), hypotension, arrhythmia, and tachycardia in CHC patients. Cardiomyopathy, angina pectoris, pericardial effusion, supraventricular arrhythmias, vasculitis, and myocardial infarction have been reported in less than or equal to 1% of CHC patients. Myocardial infarction, bundle-branch block, ventricular tachycardia, and supraventricular arrhythmia have been reported in 4% of melanoma patients. Palpitations, stroke, cardiomyopathy, angina pectoris, hypertension, and hypotension have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included hepatomegaly (6% alone, 4% with ribavirin) in CHC patients. Increased risks of hepatic decompensation and death have been reported in patients with cirrhosis. Increased ALT or AST (all grades: 77%; Grade 3/4: 11%) and increased gamma glutamyltransferase (all grades: 8%; Grade 3/4: 4%) have been reported in melanoma patients.

Endocrine

Endocrine side effects associated with peginterferon alfa-2b (with or without ribavirin) have included hypothyroidism (5%) and hyperthyroidism (3%). New onset or worsening of hypothyroidism and hyperthyroidism has been reported. The overall incidence of endocrine disorders was 2% in melanoma patients; hypothyroidism developed in 1% of these patients. TSH abnormalities, with and without clinical manifestations, have been associated with interferon therapies. Thyroiditis has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hyperglycemia (1% or less) in CHC patients. New onset or worsening of diabetes mellitus has been reported. Increased blood alkaline phosphatase (all grades: 23%) has been reported in melanoma patients. Elevated triglyceride levels have been associated with interferon alphas. Dehydration, hypertriglyceridemia, diabetic ketoacidosis, and diabetes have been reported during postmarketing experience.

A 48-year-old man experienced sudden onset of diabetic ketoacidosis seven months after the start of treatment for hepatitis C.

Respiratory

Respiratory side effects have included pharyngitis (10% alone, 12% with ribavirin), coughing (8% alone, up to 23% with ribavirin), sinusitis (7% alone, 6% with ribavirin), dyspnea (4% alone, up to 26% with ribavirin), and rhinitis (2% alone, 8% with ribavirin) in CHC patients. Emphysema, bronchiolitis obliterans, and pleural effusion have been reported in less than or equal to 1% of CHC patients. Dyspnea (all grades: 6%; Grade 3/4: 1%) and cough (all grades: 5%; Grade 3/4: less than 1%) have been reported in melanoma patients. Pulmonary infiltrates, pneumonitis, and pneumonia (sometimes fatal) have been reported with the use of peginterferon alfa-2b or alpha interferon therapy in general. Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, sarcoidosis, and pulmonary hypertension have been reported during postmarketing experience.

Ocular

Ocular side effects have included conjunctivitis (4% alone, 4% with ribavirin) and blurred vision (2% alone, 5% with ribavirin) in CHC patients. Retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, and optic neuritis have been reported in less than or equal to 1% of CHC patients. Retinal and ocular changes induced or aggravated by treatment with peginterferon alfa-2b or other alpha interferons have included decreased or loss of vision, retinopathy including macular edema, retinal hemorrhages and cotton wool spots, retinal artery or vein thrombosis, optic neuritis, papilledema, and serous retinal detachment. Partial loss of vision due to retinal thrombosis or retinopathy has been reported in at least two melanoma patients. Less than 1% of melanoma patients reported serious retinal disorders, visual disturbances, blurred vision, and reduction in visual acuity. Vogt-Koyanagi-Harada syndrome has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These have included serious, acute reactions with the use of alpha interferon therapy. Cases of acute hypersensitivity reactions (including anaphylaxis, angioedema, bronchoconstriction, urticaria) have been reported during postmarketing experience.

Renal

Renal side effects have included interstitial nephritis (1% or less) in CHC patients. Renal insufficiency, renal failure, and interstitial nephritis have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included menstrual disorder (4% alone, 7% with ribavirin) in CHC patients. Proteinuria (all grades: 7%) has been reported in melanoma patients.

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