Interferon Alfacon-1 Side Effects

Brand Names: Infergen

Please note - some side effects for Interferon Alfacon-1 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 Alfacon-1 - for the Consumer

Interferon Alfacon-1

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 Alfacon-1:

Diarrhea; dizziness; flu-like symptoms (eg, chills; headache; mild, temporary fever); hair thinning; increased sweating; joint or muscle aches; loss of appetite; mild bruising, itching, lump, redness, or swelling at the injection site; nausea; stomach upset; tiredness; 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 blood stools; blood diarrhea; chest pain; confusion; dark urine; decreased urination; fainting; fast or irregular heartbeat; high or persistent fever, chills, or sore throat; mental or mood changes (eg, depression, irritability, nervousness, anxiety, aggressive behavior); numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or headache; severe stomach or lower back pain; shortness of breath; slurred speech; sudden severe vomiting; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts of killing or hurting yourself or others; unusual bleeding or bruising; vision problems or changes; yellowing of skin or eyes.

Side Effects by Body System

General

General flu-like side effects (8% to 15%) have been reported most frequently. These have included headache (78% to 82%), fatigue (65% to 69%), fever (58% to 61%), rigors (57% to 62%), myalgia (51% to 58%), body pain (29% to 54%), arthralgia (43% to 51%), and increased sweating (12% to 13%). Less frequent side effects including hot flushes (7% to 13%) and non-cardiac chest pain have been reported.

Gastrointestinal

Gastrointestinal (GI) side effects including abdominal pain (24% to 41%), nausea (30% to 40%), diarrhea (24% to 29%), anorexia (21% to 24%), dyspepsia (12% to 21%), vomiting (12% to 13%), constipation (5% to 9%), flatulence (6% to 8%), toothache (3% to 7%), decreased saliva output (4% to 6%), ulcerative stomatitis (2% to 6%), hemorrhoids (1% to 6%), and gingivitis (1% to 5%) have been reported. Abdominal distention, GI bleeding, and gastritis have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included insomnia (24% to 39%), dizziness (18% to 22%), paresthesia (9% to 13%), hypoesthesia (8% to 10%), amnesia (2% to 10%), hypertonia (6% to 7%), somnolence (4% to 5%), taste perversion (3% to 5%), confusion (4%), and hyperesthesia (1% to 5%). Speech disorder, ataxia, gait abnormal, convulsions, loss of consciousness, memory impairment, tremors, and visual field defect have also been reported during postmarketing experience.

Hematologic

Hematologic side effects including granulocytopenia (23% to 42%), thrombocytopenia (18% to 19%), leukopenia (15% to 19%), lymphocytosis (5% to 11%), ecchymosis (4% to 6%), lymphadenopathy (4% to 6%), anemia (2% to 6%), and increased prothrombin time (1% to 3%) have been reported. Hemorrhage has been reported during postmarketing experience.

Higher doses of interferon alfacon-1 were associated with a greater incidence of leukopenia and granulocytopenia and required dose reductions in 33% of patients receiving secondary therapy.

Psychiatric

Depression has been mild to moderate in severity in patients receiving interferon alfacon-1 therapy during clinical studies and was the most common side effect resulting in drug study discontinuation.

Psychiatric side effects have included nervousness (16% to 31%), depression (18% to 26%), abnormal thinking (8% to 20%), anxiety (9% to 19%), emotional lability (3% to 12%), agitation (4% to 6%), decreased libido (4% to 5%), and apathy (2% to 5%). Delusions and hallucinations have also been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have been infrequently reported. These have included palpitation (2% to 5%) and hypertension (2% to 5%). At least one case of irreversible pulmonary artery hypertension has been reported.

Hepatic

Hepatic side effects including liver tenderness (5%) and hepatomegaly (3% to 5%) have been reported. Hepatic enzyme elevations, including ALT and AST elevations, abnormal hepatic function, hyperbilirubinemia, jaundice, ascites, and hepatic encephalopathy have also been reported during postmarketing experience.

Ocular

Ocular side effects have included conjunctivitis (4% to 8%), abnormal vision (3% to 5%), and eye pain (2% to 5%). Retinal hemorrhage, cotton wool spots, and retinal artery or vein obstruction have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported in 3% to 7% of patients. Urticaria, angioedema, bronchoconstriction, and anaphylaxis have been rarely reported.

Local

Local side effects have included injection site erythema (17% to 23%), pain (8% to 11%), and ecchymosis (5% to 6%). Injection site necrosis ulcer and bruising have also been reported during postmarketing experience.

Endocrine

Endocrine side effects have included abnormal thyroid function tests (4% to 9%) with increases in TSH and decreases in T4 mean values during the treatment period or during the 24-week posttreatment period.

Immunologic

Immunologic side effects have included infection (2% to 6%). Sepsis has been reported during postmarketing experience.

Metabolic

Metabolic side effects including hypertriglyceridemia (5% to 6%) and decreased weight (2% to 5%) have been reported. Dehydration has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included back pain (23% to 42%), limb pain (13% to 26%), skeletal pain (10% to 14%), neck pain (5% to 14%), and musculoskeletal disorder (4% to 7%). Rhabdomyolysis, arthritis, bone pain have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included alopecia (10% to 14%), pruritus (10% to 14%), rash (10% to 13%), increased sweating (11% to 12%), erythema (6% to 9%), dry skin (2% to 6%), and wound (3% to 4%). Bruising, pyoderma gangrenosum, and toxic epidermal necrolysis have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included dysmenorrheal (2% to 9%), vaginitis (5% to 8%), menstrual disorder (2% to 6%), menorrhagia (2% to 5%), genital moniliasis (2%), breast mass (5%), and breast pain (2%).

Respiratory

Respiratory side effects have included pharyngitis (17% to 31%), upper respiratory infection (16% to 31%), cough (11% to 22%), sinusitis (12% to 17%), rhinitis (7% to 13%), respiratory tract congestion (4% to 12%), upper respiratory tract congestion (7% to 10%), epistaxis (6% to 8%), dyspnea (7% to 8%), and bronchitis (1% to 6%).

Other

Vestibular side effects associated with interferon alfacon-1 have been mild and infrequent.

Other side effects have included malaise (2% to 11%), asthenia (7% to 10%), peripheral edema (1% to 9%), access pain (1% to 8%), tinnitus (4% to 6%), earache (5%), taste perversion (3% to 5%), and otitis (1% to 2%). Hearing loss and impairment have also been reported during postmarketing experience.

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