Mipomersen Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Applies to mipomersen: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Mipomersen is available only from a certified pharmacy.

You should not use mipomersen if you have active liver disease or abnormal liver function tests. Tell your doctor right away if you have liver symptoms, such as vomiting, fever, stomach pain, itching, tiredness, dark urine, or jaundice (yellowing of the skin or eyes).

Mipomersen can cause your liver enzymes to get too high. Your blood will need to be tested often. Your treatments may be stopped based on the results of these tests.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using mipomersen and call your doctor at once if you have:

• flu symptoms within 2 days after an injection--fever, chills, body aches, tired feeling, joint or muscle pain;

• pain, swelling, redness, itching, bruising, or tenderness where an injection was given; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea;

• headache; or

• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to mipomersen: subcutaneous solution.

Cardiovascular adverse events

• Common (1% to 10%): Hypertension (7%), angina pectoris (4%), palpitations (3%)^[Ref]

Dermatologic

• Very common (10% or more): [All injection site reactions (84%)], erythema (59%), pain (56%), hematoma (32%), pruritus (29%), swelling (18%), discoloration (17%)^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (14%)
• Common (1% to 10%): Vomiting (4%), abdominal pain (3%)^[Ref]

Hepatic

• Very common (10% or more): Alanine aminotransferase (ALT) increased (10%)
• Common (1% to 10%): Hepatic steatosis (7%), aspartate aminotransferase (AST) increased (6%), liver function test abnormal (5%), hepatic enzyme increased (3%)^[Ref]

Immunologic

• Rare (less than 0.1%): One case of hypersensitivity with angioedema was reported^[Ref]

Metabolic

• Common (1% to 10%): Proteinuria (9%), peripheral edema (5%)^[Ref]

Musculoskeletal

• Common (1% to 10%): Pain in extremity (7%), musculoskeletal pain (4%)^[Ref]

Nervous system

• Very common (10% or more): Fatigue (15%), headache (12%)
• Common (1% to 10%): Pyrexia (8%), chills (6%)^[Ref]

Oncologic

• Common (1% to 10%): Neoplasms [benign and malignant] (4%)^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia (3%)^[Ref]

Renal

• Rare (less than 0.1%): One case of glomerular nephritis was reported^[Ref]

Further information

Mipomersen 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.

Medical Disclaimer