Skip to Content

Betaseron Side Effects

Generic Name: interferon beta-1b

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

In 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, vasodilatation, weight gain, malaise, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

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

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

  • Abdominal or stomach pain
  • break in the skin at the injection site, with blue-black discoloration, swelling, or drainage of fluid
  • flu-like symptoms including chills, fever, generalized feeling of discomfort or illness, increased sweating, and muscle pain
  • headache or migraine
  • hives, itching, or swelling at the injection site
  • irregular or pounding heartbeat
  • redness, pain, or feeling of heat at the injection site
  • stuffy nose

Less Common

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

Rare

  • Abnormal growth in the breast
  • benign lumps in the breast
  • bleeding problems
  • bloating or swelling
  • changes in menstrual periods
  • confusion
  • convulsions (seizures)
  • cyst (abnormal growth filled with fluid or semisolid material)
  • decreased sexual ability in males
  • dry, puffy skin
  • feeling cold
  • hyperactivity
  • increased muscle tone
  • increased urge to urinate
  • loss of memory
  • mental depression with thoughts of suicide
  • problems with speaking
  • red, itching, or swollen eyes
  • swelling of the front part of the neck
  • unusual weight loss

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

Less Common

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]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

2. "Product Information. Betaseron (interferon beta-1b)." Berlex, Richmond, CA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide