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Vyondys 53 Side Effects

Generic name: golodirsen

Medically reviewed by Drugs.com. Last updated on Feb 21, 2021.

Note: This document contains side effect information about golodirsen. Some of the dosage forms listed on this page may not apply to the brand name Vyondys 53.

For the Consumer

Applies to golodirsen: intravenous solution

Side effects requiring immediate medical attention

Along with its needed effects, golodirsen (the active ingredient contained in Vyondys 53) 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 or nurse immediately if any of the following side effects occur while taking golodirsen:

More common

  • Fever

Incidence not known

  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, scaly skin
  • difficulty in breathing swallowing
  • hives, itching skin, or rash
  • nausea
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
  • swelling
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of golodirsen 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:

More common

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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

Frequently asked questions

References

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

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.