Peginterferon alfa-2b Side Effects

Please note - some side effects for Peginterferon alfa-2b may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Peginterferon alfa-2b - for the Consumer

Peginterferon alfa-2b

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 Peginterferon alfa-2b:

Diarrhea; dizziness; dry mouth or skin; flushing; hair thinning or loss; headache; increased sweating; joint pain; loss of appetite; muscle aches; nausea; stomach pain or upset; stuffy nose; temporary 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, or tongue; unusual hoarseness); blood in the urine; bloody stools or diarrhea; butterfly-shaped rash on the face; chest pain; confusion; decreased hearing or hearing loss; decreased urination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; memory loss; mental or mood problems (eg, aggression, depression, exaggerated sense of well-being, irritability); numbness or weakness on one side of the body; red, swollen, blistered, or peeling skin; severe or persistent dizziness, tiredness, or weakness; severe or persistent joint or muscle pain; severe or persistent nausea or vomiting; severe or persistent stomach or lower back pain; shortness of breath; slurred speech; suicidal thoughts or actions; swelling in the hands or feet; symptoms of high blood sugar (eg, increased thirst, appetite, or urination; rapid breathing; unusual drowsiness); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unexplained weight changes); thoughts of hurting yourself or other people; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

Side Effects by Body System

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) 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 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). 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. A small number of patients developed mild to moderate gout. Pure red cell aplasia and thrombotic thrombocytopenic purpura have been reported during postmarketing experience. At least one case of severe bone marrow hypoplasia has been reported.

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). Nerve palsy (facial, oculomotor), transient ischemic attack, and loss of consciousness have been reported in less than or equal to 1% of patients. Vertigo, seizures, memory loss, migraine headache, paresthesia, hearing impairment, hearing loss, 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). 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 patients with and without a previous psychiatric disorder. Psychosis and hallucinations have been reported in patients treated with alpha interferons. Homicidal ideation has been reported during postmarketing experience.

Other

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). 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). Gout and rheumatoid arthritis have been reported in less than or equal to 1% of patients. Rhabdomyolysis and myositis have been reported during postmarketing experience.

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) have been reported. Localized skin ulcerations have been reported after subcutaneous and intramuscular injection.

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). Gastroenteritis and pancreatitis have been reported in less than or equal to 1% of 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 has been reported during postmarketing experience.

Dermatologic

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.

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). Aggravated psoriasis, urticaria, and phototoxicity have been reported in less than or equal to 1% of patients. At least one case of generalized exfoliative dermatitis has been reported. Erythema multiforme, urticaria, and psoriasis have been reported during postmarketing experience.

Immunologic

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.

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. Lupus-like syndrome, sarcoidosis, and infection (sepsis, pneumonia, abscess, cellulitis) have been reported in less than or equal to 1% of 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. Bacterial infection (including sepsis) and systemic lupus erythematosus have been reported during postmarketing experience.

Cardiovascular

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

Hepatic

Hepatic side effects have included hepatomegaly (6% alone, 4% with ribavirin).

Endocrine

Endocrine side effects associated with peginterferon alfa-2b (with or without ribavirin) have included hypothyroidism (5%) and hyperthyroidism (3%). Elevated triglyceride levels and TSH abnormalities with and without clinical manifestations have been associated with interferon therapies.

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). Emphysema, bronchiolitis obliterans, and pleural effusion have been reported in less than or equal to 1% of patients. Pulmonary infiltrates, pneumonitis, and pneumonia (sometimes fatal) have been reported with the use of peginterferon alfa-2b or alpha interferon therapy in general.

Ocular

Ocular side effects have included conjunctivitis (4% alone, 4% with ribavirin) and blurred vision (2% alone, 5% with ribavirin). 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 patients. 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. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and cases of acute hypersensitivity reactions (including anaphylaxis, angioedema, urticaria) have been reported during postmarketing experience.

Renal

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

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