Note: This document contains side effect information about omaveloxolone. Some dosage forms listed on this page may not apply to the brand name Skyclarys.
Applies to omaveloxolone: oral capsule.
Serious side effects of Skyclarys
Along with its needed effects, omaveloxolone (the active ingredient contained in Skyclarys) 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 Skyclarys
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]
