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Golodirsen Side Effects

Medically reviewed by Drugs.com. Last updated on July 1, 2020.

For the Consumer

Applies to golodirsen: intravenous solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Falls.
  • A fast heartbeat.
  • Ear pain.
  • Bone pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to golodirsen: intravenous solution

General

The most commonly reported adverse reactions have included headache, pyrexia, falls, abdominal pain, nasopharyngitis, cough, vomiting, and nausea.[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Nervous system

Very common (10% or more): Headache (41%)

Common (1% to 10%): Dizziness

Gastrointestinal

Very common (10% or more): Abdominal pain (27%), vomiting (27%), nausea (20%)

Common (1% to 10%): Diarrhea, oropharyngeal pain, constipation

Local

Common (1% to 10%): Administration site pain, catheter site related reaction

Immunologic

Common (1% to 10%): Influenza, seasonal allergy

Musculoskeletal

Common (1% to 10%): Back pain, ligament strain, fracture

Respiratory

Very common (10% or more): Nasopharyngitis (27%)

Common (1% to 10%): Rhinitis

Other

Very common (10% or more): Pyrexia (41%), fall (29%)

Common (1% to 10%): Pain, ear infection

Cardiovascular

Common (1% to 10%): Tachycardia

Dermatologic

Common (1% to 10%): Contusion, skin abrasion

References

1. "Product Information. Vyondys 53 (golodirsen)." Sarepta Therapeutics, Cambridge, MA.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.