Betaseron Side Effects

Generic name: interferon beta-1b

Medically reviewed by Drugs.com. Last updated on Jun 1, 2024.

Note: This document provides detailed information about Betaseron.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have dark urine, persistent loss of appetite, flu-like symptoms, headache, continuing vomiting, general feeling of tiredness or weakness, light-colored stools, right upper stomach pain or tenderness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause redness, pain, or swelling at the injection site. Some patients have developed serious skin infection or damage (necrosis), including a permanent depression under the skin at the injection site. Contact your doctor right away if you notice depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

This medicine commonly causes a flu-like reaction, with aching muscles, chills, fever, headaches, joint pain, and nausea. Using your shot at bedtime may allow you to sleep through the symptoms. Your doctor may want you to take a medicine to help control the pain or fever (eg, acetaminophen or ibuprofen). Carefully follow your doctor's instructions about how to prevent or treat these symptoms.

This medicine may lower the number of white blood cells in the blood. This will increase your chance of getting an infection. It can also lower the number of platelets in the blood. Platelets are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome may occur while you are using this medicine. Tell your doctor right away if you have black, tarry stools, blood in the urine, difficulty with speaking, fever, pinpoint red spots on the skin, seizures, stomach pain, unusual bleeding or bruising, or yellow eyes or skin.

This medicine may cause pulmonary arterial hypertension. Check with your doctor right away if you have trouble breathing or unusual tiredness or weakness.

Check with your doctor right away if you have a rash, bloody or cloudy urine, drowsiness, headache, paleness or cold feeling in fingertips and toes, tingling or pain in fingers or toes when exposed to cold, swelling of the face, feet, or lower legs, trouble breathing, or unusual weight gain. These may be symptoms of a drug-induced lupus erythematosus.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

The removable rubber cap of the prefilled syringe contains natural rubber latex, which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

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:

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:

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]

See also:

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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