Betaseron Side Effects

Generic name: interferon beta-1b

Medically reviewed by Drugs.com. Last updated on Jun 21, 2024.

Note: This document provides detailed information about Betaseron Side Effects associated with interferon beta-1b. Some dosage forms listed on this page may not apply specifically to the brand name Betaseron.

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 side effects

• 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 side effects

• 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 side effects

• 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.

General adverse events

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

Cardiovascular

• Common (1% to 10%): Tachycardia
• Rare (Less than 0.1%): Cardiomyopathy, congestive heart failure, palpitations, arrhythmia, tachycardia, vasodilatation, chest pain, hypertension^[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]

Further information

Betaseron side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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