Interferon alfa-2b Side Effects

Brand Names: Intron A

Please note - some side effects for Interferon 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 Interferon alfa-2b - for the Consumer

Interferon Alfa-2b Powder

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 Interferon Alfa-2b Powder:

Constipation; diarrhea; dizziness; dry mouth; hair thinning; increased sweating; loss of appetite; mild flu-like symptoms (eg, headache, muscle aches, mild fever or chills); mild redness, swelling, or itching at the injection site; nausea; tiredness; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; bloody diarrhea; chest pain; confusion; dark urine; decreased concentration; decreased urination; fainting; fast or irregular heartbeat; hearing problems or loss of hearing; high or persistent fever, chills, or sore throat; mental or mood changes (eg, aggressive behavior, anxiety, depression, hallucination, irritability, nervousness); one-sided weakness; pain or numbness of an arm or leg; pale stools; persistent feeling of being unusually cold; reddened, blistered, swollen, or peeling skin; severe lower back pain; severe or persistent cough; severe or persistent dizziness or headache; severe or persistent muscle pain or weakness; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; slurred speech; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts of killing yourself or others; unusual bleeding or bruising; vision problems or changes (eg, blurred or double vision, decreased vision, or loss of vision); yellowing of the skin or eyes.

Interferon Alfa-2b Solution

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 Interferon Alfa-2b Solution:

Constipation; diarrhea; dizziness; dry mouth; mild flu-like symptoms (eg, headache, muscle aches, mild fever or chills); hair thinning; increased sweating; loss of appetite; mild redness, swelling, or itching at the injection site; nausea; tiredness; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; bloody diarrhea; chest pain; confusion; dark urine; decreased concentration; decreased urination; fainting; fast or irregular heartbeat; hearing problems or loss of hearing; high or persistent fever, chills, or sore throat; mental or mood changes (eg, aggressive behavior, anxiety, depression, hallucination, irritability, nervousness); one-sided weakness; pain or numbness of an arm or leg; pale stools; persistent feeling of being unusually cold; reddened, blistered, swollen, or peeling skin; severe lower back pain; severe or persistent cough; severe or persistent dizziness or headache; severe or persistent muscle pain or weakness; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; slurred speech; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts of killing yourself or others; unusual bleeding or bruising; vision problems or changes (eg, blurred or double vision, decreased vision, or loss of vision); yellowing of the skin or eyes.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included anorexia (1% to 69%), nausea (17% to 66%), diarrhea (2% to 45%), vomiting (2% to 32%), altered taste (up to 24%), abdominal pain (1% to 21%), constipation (up to 14%), gingivitis (up to 14%), loose stools (up to 10%), dyspepsia (up to 7%), and pancreatitis (less than 5%). Pancreatitis has also been reported during postmarketing experience.

Hepatic

Hepatic side effects have included increased transaminases (elevated SGOT up to 63%) and right upper quadrant pain (up to 15%).

Psychiatric

Psychiatric side effects have included depression (3% to 40%) and anxiety (up to 9%). Frontal subcortical dementia and choreic movements mimicking Huntington's disease have been reported. Psychosis including hallucinations have been reported during postmarketing experience.

Frontal subcortical dysfunction and choreic movements of the limbs appeared in a 68-year-old woman almost 2 years after the initiation of interferon alfa-2b (3 x 10(6) units/day) for CML. She had no history of psychiatric disorders and no hereditary neurodegenerative disease with long term recombinant interferon therapy. Symptoms of personality changes, short memory loss, and choreic movements progressively worsened over a 4 months period until she became bedridden. One month after interferon alfa-2b therapy was discontinued patient's cognitive performance had improved and choreic movements had disappeared. Clinical examination of her cognitive performances at six and 12 months later were normal.

Dermatologic

Dermatologic side effects have included alopecia (up to 38%), rash (up to 25%), pruritus (up to 11%), dry skin (up to 10%), dermatitis (up to 8%), and hair discoloration. Trichomegaly following treatment with interferon alfa-2b has been reported in a few cases, but mechanism is unknown. Radiation recall dermatitis manifested as an erythematous macular rash in the region of irradiation has been reported after a high-dose of interferon alfa-2b. Aseptic necrosis of the skin and ulceration have been reported. Erythema multiforme has been reported during postmarketing experience.

Case reports of aseptic necrosis of the skin and ulceration have been described in patients with Kaposi's sarcoma associated with HIV infection treated with interferon alfa-2b.

Respiratory

Respiratory side effects have included dyspnea (up to 34%), coughing (up to 31%), pharyngitis (up to 31%), sinusitis (up to 21%), nonproductive cough (up to 14%), nasal congestion (up to 10%), bronchitis (up to 10%), and epistaxis (up to 7%). At least two cases of severe asthma have been reported during postmarketing experience.

Severe asthma developed in two patients as soon as 8 weeks after the start of interferon alfa-2b therapy in patients diagnosed with chronic hepatitis C and mild asthma.

Nervous system

Nervous system side effects have included headache (21% to 62%), somnolence (up to 33%), dizziness (up to 24%), irritability (up to 22%), paresthesia (less than 1% to 21%), impaired concentration (up to 14%), amnesia (up to 14%), confusion (up to 12%), insomnia (up to 12%), hypoesthesia (up to 10%), nervousness (up to 3%), and decreased libido (up to 5%). Hearing loss has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (16% to 75%), musculoskeletal pain (up to 21%), and arthralgia (up to 19%). Myositis has been reported during postmarketing experience.

Immunologic

Immunologic side effects have included moniliasis (up to 17%) and herpes simplex (up to 5%).

Hematologic

Hematologic side effects have included neutropenia (up to 14%), thrombocytopenia (up to 10%), and bleeding (up to 8%). Aplastic anemia, pure red cell aplasia, sarcoidosis or exacerbation of sarcoidosis, idiopathic thrombocytopenia purpura, and thrombotic thrombocytopenic purpura have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included amenorrhea (up to 12%), polyuria (up to 10%), urinary tract infections (up to 5%), and gynecomastia (less than 5%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 9% in chronic hepatitis C). Angina, arrhythmia, atrial fibrillation, bradycardia, cardiac failure, cardiomegaly, cardiac failure, cardiomyopathy, coronary artery disorder, extrasystole, heart valve disorder, hematoma, hypotension, palpitations, phlebitis, postural hypotension, pulmonary embolism, Raynaud's disease, tachycardia, thrombosis, and varicose vein have been reported in less than 5% of patients.

Endocrine

Endocrine side effects have included aggravation of diabetes mellitus, goiter, hyperthyroidism, and hypothyroidism in less than 5% of patients.

Ocular

Ocular side effects have included at least seven cases of retinopathy in patients receiving high dose interferon alfa-2b.

Renal

Renal side effects have included nephritic syndrome, renal failure, and renal insufficiency during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included Stevens-Johnson syndrome and toxic epidermal necrolysis during postmarketing experience.

Local

Local side effects including inflammation at the site of injection have been reported in up to 20% of patients. Injection site necrosis has also been reported during postmarketing experience.

Other

Other side effects have included fatigue (8% to 96%), fever (47% to 94%), influenza-like symptoms (up to 79%), asthenia (up to 63%), chills (up to 54%), rigors (up to 42%), dry mouth (up to 28%), chest pain (up to 28%), increased sweating (1% to 21%), back pain (up to 19%), unspecified pain (up to 18%), malaise (up to 14%), facial edema (up to 10%), weight loss (less than 1% to 10%), and virilism (less than 5%).

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