Note: This document contains side effect information about interferon beta-1b. Some dosage forms listed on this page may not apply to the brand name Betaseron.

Summary

Common side effects of Betaseron include: uterine hemorrhage, abdominal pain, antibody development, asthenia, chest pain, decreased white blood cell count, fever, flu-like symptoms, headache, hypertonia, increased serum alanine aminotransferase, injection site reaction, insomnia, leukopenia, myalgia, pain, anxiety, arthralgia, constipation, diarrhea, disorder of integument, dizziness, dyspepsia, lymphocytopenia, myasthenia, nausea, peripheral edema, skin rash, urinary urgency, abnormal absolute neutrophil count, chills, and inflammation at injection site. Other side effects include: alopecia, dyspnea, hypertension, lower limb cramp, lymphadenopathy, palpitations, tachycardia, tissue necrosis at injection site, impotence, nervousness, peripheral vascular disease, urinary frequency, vasodilation, weight gain, malaise, and diaphoresis. Continue reading for a comprehensive list of adverse effects.

Applies to interferon beta-1b: subcutaneous powder for solution.

Serious side effects of Betaseron

Along with its needed effects, interferon beta-1b (the active ingredient contained in Betaseron) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking interferon beta-1b:

More common

• Blue-green to black skin discoloration
• changes in menstrual periods
• chills
• cough
• decreased sexual ability in males
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• irregular or pounding heartbeat
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny or stuffy nose
• shivering
• sore throat
• stomach pain
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bloody or cloudy urine
• changes in vision
• cold hands and feet
• difficult, burning, or painful urination
• frequent urge to urinate
• pelvic pain
• swollen glands
• trouble breathing
• unusual weight gain

Incidence not known

• Black, tarry stools
• bleeding problems
• bleeding gums
• bloating or swelling
• blood in the urine or stools
• chest pain, discomfort, or tightness
• confusion
• dry, puffy skin
• feeling cold
• hoarseness or husky voice
• increased muscle tone
• increased urge to urinate
• light-colored stools
• loss of memory
• nervousness
• nosebleeds
• pale skin
• pinpoint red spots on the skin
• problems with speaking
• red, itching, or swollen eyes
• restlessness
• seizures
• sensitivity to heat
• swelling of the feet or lower legs
• swelling of the front part of the neck
• trouble sitting still
• unusual bleeding or bruising
• unusual weight loss
• upper right abdominal or stomach pain
• yellowing eyes and skin

Other side effects of Betaseron

Some side effects of interferon beta-1b may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• dizziness
• loss of voice
• menstrual pain or other changes

Incidence not known

• Difficulty in moving
• loss or thinning of the hair
• muscle stiffness

For Healthcare Professionals

Applies to interferon beta-1b: subcutaneous powder for injection.

Cardiovascular

Common (1% to 10%): Tachycardia

Rare (Less than 0.1%): Cardiomyopathy, congestive heart failure, palpitations, arrhythmia, tachycardia, vasodilatation, chest pain, hypertension^[Ref]

Dermatologic

Very common (10% or more): Skin rashes (25%), increased sweating

Common (1% to 10%): Contusion, pruritus, erythematous rash, maculopapular rash, night sweats

Uncommon (0.1% to 1%): Alopecia, allergic dermatitis, erythema, urticaria

Rare (0.01% to 0.1%): Skin ulceration/necrosis at the site of injection, Quincke's edema (angioedema), erythema multiforme, Stevens-Johnson syndrome

Very rare (less than 0.01%): Calcified subcutaneous nodules, psoriasis, periungual and nail alterations

Frequency not reported: Rash vesicular^[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism, hyperthyroidism^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (27%), diarrhea (17%), constipation (12%), vomiting (10%)

Common (1% to 10%): Abdominal pain

Frequency not reported: Dry mouth, dyspepsia, pancreatitis^[Ref]

General

Influenza-like symptoms (e.g., myalgia, fever, chills, sweating, asthenia, headache, nausea) are the most common adverse reactions.^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (19%), cystitis (11%)

Frequency not reported: Metrorrhagia, menorrhagia, urinary incontinence, increase in the frequency of micturition^[Ref]

Hematologic

Very common (10% or more): Lymphopenia (14%), leukopenia (11%), neutropenia, thrombocytopenia, anemia

Common (1% to 10%): Neutrophil count decreased, hematocrit decreased, blood potassium increased, blood urea nitrogen increased

Uncommon (0.1% to 1%): Platelet count decreased

Rare (Less than 0.1%): Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome,

Frequency not reported: Pancytopenia^[Ref]

Hepatic

Very common (10% or more): Alanine aminotransferase increased (26%), aspartate aminotransferase increased (16%)

Common (1% to 10%): Gamma-glutamyl-transferase increased

Uncommon (0.1% to 1%): Hepatitis (with or without icterus)

Rare (Less than 0.1%): Hepatic failure, autoimmune hepatitis

Frequency not reported: Elevation of hepatic transaminases (SGPT and SGOT), bilirubinemia, jaundice^[Ref]

Hypersensitivity

Rare (Less than 0.1%): Anaphylactic reactions

Frequency not reported: Other allergic reactions^[Ref]

Immunologic

Very common (10% or more): Influenza-like symptoms (49%)

Frequency not reported: Systemic lupus erythematosus, anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (angioedema, dyspnea, urticaria, rash, pruritic rash)^[Ref]

Local

Very common (10% or more): Injection site erythema (62%), injection site pain (15%), injection site pruritus (13%), injection site bruising

Common (1% to 10%): Injection site edema, injection site warmth, injection site hematoma, injection site rash

Uncommon (0.1% to 1%): Injection site infections (which could be severe)

Rare (Less than 0.1%): Injection site cellulitis (which could be severe)

Frequency not reported: Injection site abscess, injection site reaction, injection site inflammation, injection site necrosis, injection site bleeding^[Ref]

Metabolic

Frequency not reported: Weight decreased, weight increased^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (19%), back pain (20%), pain in extremity (19%), arthralgia (16%), muscular weakness (12%), muscle spasms (10%)

Common (1% to 10%): Muscle spasticity, muscle cramp, neck pain, arthralgia, muscle stiffness, musculoskeletal stiffness

Rare (0.01% to 0.1%): Drug induced lupus erythematosus

Frequency not reported: Arthritis^[Ref]

Nervous system

Very common (10% or more): Headache (67%), dizziness (16%), paresthesia (12%)

Common (1% to 10%): Hypoesthesia

Uncommon (0.1% to 1%): Facial hypoesthesia

Frequency not reported: Neurological symptoms, syncope, hypertonia, seizures, migraine^[Ref]

Other

Very common (10% or more): Pyrexia (45%), asthenia (24%), pain (23%), fever (20%), chills (19%)

Common (1% to 10%): Fatigue, malaise, hyperthermia, vertigo

Frequency not reported: Tachyphylaxis, sudden hearing loss, tinnitus (ototoxic effects resolved 7 to 14 days after discontinuation of the drug)^[Ref]

Psychiatric

Common (1% to 10%): Depression/suicidal ideation, insomnia, somnolence

Uncommon (0.1% to 1%): Anxiety

Frequency not reported: Suicide attempt, suicide, psychosis, anxiety, confusion, emotional lability, anhedonia, psychotic thoughts, mood disturbances, hypersexuality, aggressive behavior, panic attacks^[Ref]

Renal

Rare (Less than 0.1%): Nephrotic syndrome, glomerulosclerosis^[Ref]

Respiratory

Very common (10% or more): Oropharyngeal pain (28%), nasopharyngitis (24%), upper respiratory tract infection (21%), cough (16%), sinusitis (14%)

Common (1% to 10%): Rhinorrhea, bronchitis

Rare (0.01% to 0.1%): Dyspnea

Frequency not reported: Pulmonary arterial hypertension^[Ref]