Omaveloxolone Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 18, 2024.

Applies to omaveloxolone: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Ask your doctor which form of birth control is right for you while you are using this medicine and for 28 days after the last dose.

This medicine may increase a blood protein called B-Type Natriuretic Peptide (BNP), which affects the heart. Check with your doctor right away if you have decrease in amount of urine, noisy, rattling, or trouble breathing, fast heartbeat, swelling of the fingers, hands, feet, or lower legs, or weight gain.

This medicine may cause changes in your cholesterol levels. Talk to your doctor about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

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:

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:

For healthcare professionals

Applies to omaveloxolone: oral capsule.

General adverse events

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]

See also:

Further information

Omaveloxolone 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