Betaseron Side Effects

Betaseron (interferon) is made from human proteins. Interferons help the body fight viral infections.

Betaseron is used to treat relapsing multiple sclerosis (MS). Betaseron will not cure MS, it will only decrease the frequency of relapse symptoms.

Do not use Betaseron if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using Betaseron if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Before using Betaseron, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • a thyroid disorder;
  • epilepsy or other seizure disorder;
  • a bleeding or blood-clotting disorder, such as hemophilia;
  • anemia (lack of red blood cells); or
  • a history of depression or suicidal behavior.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Betaseron.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use Betaseron if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether Betaseron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Betaseron and call your doctor at once if you have any of these serious side effects:

  • depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
  • bruising, swelling, oozing, or skin changes where the injection was given;
  • weight changes, pounding heartbeats, feeling too hot or cold;
  • fever, chills, body aches, flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Betaseron side effects may include:

  • weakness;
  • headache;
  • muscle pain or weakness;
  • sleep problems (insomnia);
  • stomach pain;
  • swelling in your hands or feet;
  • skin rash; or
  • irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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