Interferon beta-1b Side Effects

Brand Names: Betaseron, Extavia

Please note - some side effects for Interferon beta-1b 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 Interferon beta-1b - for the Consumer

Interferon Beta-1b 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 Beta-1b Solution:

Decreased sexual ability; flu-like symptoms (eg, low-grade fever, chills, general body discomfort; unusual sweating); frequent urination; headache; joint pain; mild pain, swelling, or redness at the injection site; muscle pain or weakness; nausea; stomach upset; trouble sleeping; unusual spotting or menstrual bleeding; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue-black discoloration, skin breakdown, oozing, or persistent pain or swelling around the injection site; chest pain; decreased coordination; feeling cold or hot all the time; mood or mental changes (eg, depression, anxiety, nervousness, severe or persistent trouble sleeping); muscle stiffness; seizures; severe or persistent headache or dizziness; shortness of breath; suicidal thoughts or behaviors; swelling of the hands, ankles, or feet; swollen lymph nodes; symptoms of infection (eg, severe or persistent fever, chills, sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, right-sided stomach pain); unusual bruising or bleeding; unusual weight gain or loss.

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

General

The most serious side effects reported in all studies were depression, suicidal ideation, and injection site necrosis. The most frequently reported side effects were lymphopenia (lymphocytes less than 1500/mm3), injection site reaction, asthenia, flu-like symptom complex, headache, and pain. The most commonly reported side effects resulting in clinical intervention (e.g., discontinuation of interferon beta-1b, dosage adjustment, or the need for treatment of side effect symptom with concomitant medication) were depression, flu-like symptom complex, injection site reactions, leukopenia, elevated liver enzymes, asthenia, hypertonia, and myasthenia.

Local

Local side effects have included injection site reaction (various kinds; 78%) and injection site necrosis (4%). Injection site reaction (various kinds) includes injection site inflammation (42%), injection site pain (16%), injection site hypersensitivity (4%), injection site mass (2%), injection site edema (2%), injection site reaction, injection site hemorrhage, injection site atrophy, and nonspecific reactions. Severe necrotic lesions have occurred.

About 69% of patients experienced injection site reactions during the first 3 months of therapy with the incidence decreasing to about 40% at the end of the trials.

Other

Flu-like symptom complex appears to occur most frequently during the first 3 months of therapy, and abates with continued treatment.

Other side effects have included flu-like symptom complex (denotes flu syndrome and/or a combination of at least 2 side effects from fever, chills, myalgia, malaise, sweating; 57%), asthenia (53%), pain (42%), fever (31%), chills (21%), peripheral edema (12%), chest pain (9%), and malaise (6%).

Hematologic

Hematologic side effects have included decreased lymphocyte count (less than 1500/mm3; 86%), decreased white blood cell count (less than 3000/mm3; 13% to 18%), decreased absolute neutrophil count (less than 1500/mm3; 13%), and lymphadenopathy (6%). Anemia and thrombocytopenia have been reported during postmarketing experience.

Psychiatric

One suicide and four suicide attempts were reported in 372 patients treated with 1.6 or 8 million international units every other day, while none were reported in patients on placebo.

Psychiatric side effects have included depression (any severity; about 30%), suicidal ideation, suicide attempts, and suicide. Anxiety, confusion, depersonalization, emotional lability, and psychotic symptoms have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (50%), insomnia (21%), incoordination (17%), somnolence, and myasthenia. Sudden hearing loss, which was reversible within 7 to 14 days of drug discontinuation, has been reported. Ataxia, convulsion, dizziness, and paresthesia have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included hypertonia (40%) and myalgia (23%). In a study of 124 multiple sclerosis patients, myalgia (44%) and myasthenia (13%) were reported. A study of 19 patients with primary progressive multiple sclerosis reported frequent and clinically significant increase in spasticity that appeared approximately 2 months after start of interferon beta-1b. Arthralgia has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (21%) and skin disorder (10%). Contact dermatitis, erythema nodosum, exfoliative dermatitis, furunculosis, hirsutism, leukoderma, lichenoid dermatitis, maculopapular rash, psoriasis, seborrhea, benign skin neoplasm, skin carcinoma, skin hypertrophy, skin necrosis, skin ulcer, vesiculobullous lesions, sarcoid-like dermatitis, and septal panniculitis have been reported. Alopecia, pruritus, skin discoloration, and urticaria have been reported during postmarketing experience.

A case of sarcoid-like dermatitis is reported in a 57-year-old white man diagnosed with multiple sclerosis. The cutaneous eruption that developed 2 months after initiation of interferon beta-1b therapy histologically resembled sarcoidal granulomas, but without distinctive features of true sarcoidosis.

A case of cutaneous necrosis in a 38-year-old woman diagnosed with relapsing-remitting multiple sclerosis is believed to be a result of an immunological response to the improperly dissolved lyophilized drug. The patient was rechallenged with the drug, after introducing changes to the way she reconstituted the drug, without any reports of scars.

Hepatic

Hepatic side effects have included elevated liver enzymes, including elevated alanine aminotransferase (SGPT greater than 5 times baseline; 12%) and aspartate aminotransferase (SGOT greater than 5 times baseline; 4%). Hepatitis and elevated gamma-glutamyltransferase have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (16%). Diarrhea, nausea, pancreatitis, and vomiting have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included menstrual disorders/irregularities (12%) and metrorrhagia (9%) in premenopausal women, urinary urgency (11%), and male impotence (8%). Severe vaginal bleeding has been reported. Menorrhagia, urinary tract infection, and urosepsis have been reported during postmarketing experience.

A 19-year-old white woman diagnosed with multiple sclerosis experienced severe vaginal bleeding when her dose of interferon beta-1b was increased, 1 month from the start of therapy, from 4 to 8 million international units.

Cardiovascular

Development of fatal capillary leak syndrome has been associated with the administration of cytokines to patients with a preexisting monoclonal gammopathy.

Cardiovascular side effects have included hypertension (6%). Cardiomyopathy, palpitations, tachycardia, deep vein thrombosis, pulmonary embolism, vasodilatation, and fatal capillary leak syndrome have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and other allergic reactions.

Respiratory

Respiratory side effects have included dyspnea (6%). Bronchospasm and pneumonia have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypocalcemia, hyperuricemia, increased triglycerides, anorexia, decreased weight, and increased weight during postmarketing experience.

Immunologic

Immunologic side effects have included the development of antibodies against interferon beta, often as early as 3 months after the start of treatment. The antibodies may bind to and block the beneficial effect of interferon beta in multiple sclerosis. The overall clinical significance is unknown.

Results of a prospective study suggest that several autoimmune events may occur during interferon beta treatment of multiple sclerosis and recommends the close monitoring of thyroid, liver function, and autoantibodies.

Neutralizing antibodies formation occurred after the 24-week treatment in 95% of patients treated with natural interferon beta compared to 27% of patients treated with recombinant interferon beta.

Endocrine

Endocrine side effects have included hypothyroidism, hyperthyroidism, and thyroid dysfunction during postmarketing experience.

Renal

Renal side effects have included hemolytic uremic syndrome and nephrotic syndrome with minimal histologic changes of the glomerulus during postmarketing experience. Upon withdrawal of interferon beta therapy these side effects subsided.

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