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The following safety information outlines the key risks and precautions associated with the use of Betaseron (interferon beta-1b). It is important to review these details carefully and discuss any concerns with your healthcare provider.

• Liver Complications: Although infrequent, Betaseron can lead to severe liver issues, including liver failure or even death. Regular blood tests may be required to monitor liver function. Immediate medical attention is necessary if you experience symptoms such as abdominal swelling, yellowing of skin or eyes, unusual stool colors, coughing or vomiting blood, confusion, slurred speech, mood changes, or personality shifts. Those with a history of liver issues, those taking liver-damaging medications, or those who consume alcohol are at increased risk.

• Mental Health Concerns: The medication may induce depression or suicidal thoughts. This risk applies to all users. It is crucial to inform your healthcare provider if any mood or behavioral changes occur, or if you experience self-harm thoughts. Depending on the severity, discontinuation of Betaseron may be necessary.

• Heart Failure Worsening: Individuals with heart failure may notice an exacerbation of symptoms when using Betaseron. Notify your provider if you have heart failure or symptoms such as breathlessness, leg swelling, irregular heartbeat, fatigue, or weakness. This is particularly important for those with a history of heart failure.

• Injection Site Reactions: Skin necrosis at the injection site is possible, typically within the first four months of treatment, but can occur over a year later. This may manifest as lesions that extend into deeper layers of skin or muscle. Contact your provider if you notice skin breakdown, discoloration, swelling, or fluid leakage at the injection site.

• Reduced White Blood Cell Count: Betaseron can lower white blood cell levels, increasing infection risk. If your white blood cell count becomes too low, discontinuation may be required. Notify your healthcare provider if you develop signs of infection like fever, exhaustion, chills, cough, or breathing difficulties.

• Blood Disorders: Rarely, Betaseron can cause thrombotic microangiopathy (TMA), a severe blood condition characterized by small vessel blood clots. TMA can occur anytime from weeks to years after starting the medication. Discontinue Betaseron and inform your provider immediately if you experience symptoms such as unusual bruising, skin spots, pale skin, jaundice, fever, fatigue, or confusion.

• Drug-Induced Lupus: The medication can trigger lupus, an autoimmune condition. Watch for symptoms such as muscle or joint pain, swelling, rash, pelvic pain, frequent or painful urination, nausea, or cold extremities. If diagnosed with lupus, discontinuation of Betaseron is necessary.

Contraindications: Betaseron should not be used if you cannot receive human albumin. Consult your healthcare provider if this applies to you.

When taking this medication, you may experience some common side effects. These include reactions at the injection site such as pain, swelling, or redness, along with flu-like symptoms like headache, fever, chills, and muscle aches. These flu-like symptoms tend to improve over time and can be eased by taking pain relievers like acetaminophen or ibuprofen. Other mild effects include abdominal discomfort, constipation, diarrhea, upset stomach, and nausea. Some people might also notice muscle weakness, stiffness, difficulty sleeping, and rashes.

It's important to be aware of more serious side effects, which, although rare, require immediate attention. These include signs of a severe allergic reaction such as rash, itching, swelling of the face, tongue, or throat, severe dizziness, and trouble breathing. You should also seek urgent care if you experience symptoms of heart failure, such as shortness of breath or swelling in the legs, as well as signs of liver problems, including yellowing of the skin or eyes, and abdominal swelling. Worsening depression, thoughts of suicide, seizures, and serious infections are other severe side effects that necessitate prompt medical attention.

Additionally, some users may experience chest pain, high blood pressure, sexual dysfunction, or difficulty breathing. If you see unusual symptoms like easy bruising, bleeding, or signs of blood problems such as yellowing of the skin, or feel excessively tired without explanation, contact your healthcare provider. This medication can also lower your ability to fight infections, so report any persistent sore throats, fever, or cough to your doctor. Always stay alert to your body's reactions and seek medical advice if you notice anything concerning.