Omaveloxolone Side Effects

Medically reviewed by Drugs.com. Last updated on May 24, 2023.

Applies to omaveloxolone: oral capsule.

Serious side effects of Omaveloxolone

Along with its needed effects, omaveloxolone 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 immediately if any of the following side effects occur while taking omaveloxolone:

More common

• Back pain
• bone pain
• chills
• cough
• dark urine
• decrease in amount of urine
• diarrhea
• fast heartbeat
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches, pains, and spasms
• nausea or vomiting
• noisy, rattling, or trouble breathing
• runny nose
• shivering
• sore throat
• stomach pain, severe
• sweating
• swelling of the fingers, hands, feet, or lower legs
• unusual tiredness or weakness
• weight gain
• yellow eyes or skin

Other side effects of Omaveloxolone

Some side effects of omaveloxolone 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

• Mouth or throat pain
• rash

For Healthcare Professionals

Applies to omaveloxolone: oral capsule.

General

The most common side effects in 20% or more patients were elevated liver enzymes [aspartate aminotransferase (AST)/alanine aminotransferase (ALT)], headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.^[Ref]

Dermatologic

Very common (10% or more): Rash (10%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (33%), abdominal pain (29%), diarrhea (20%), oropharyngeal pain (18%), vomiting (16%)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (12%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (20%), muscle spasms (14%), back pain (13%)^[Ref]

Nervous system

Very common (10% or more): Headache (37%)^[Ref]

Other

Very common (10% or more): Elevated liver enzymes [(aspartate aminotransferase (AST)/ alanine transaminase (ALT)] (37%), fatigue (24%), influenza (16%)^[Ref]

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.

Medical Disclaimer