Brand name · Omaveloxolone
Skyclarys: adverse event reports filed with FDA
1,622 reports list it as a suspect or interacting product, 2023–2026.
- 1,622
- reports as suspect product
- 0% of all reports · about 541 a year
- 539
- reports, 12 months to June 2026
- 583 in the 12 months before
- 40.1%
- marked serious by the reporter
- 57.4% across all reports
- 4.7%
- record death among outcomes, as reported
- 76 reports · not verified by FDA
1,622 adverse event reports received by FDA list the brand name Skyclarys (omaveloxolone) as a suspect or interacting product, from July 2023 to June 2026. A further 2 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 539 reports listed it, close to the 583 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 541 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are fatigue (9%), hepatic enzyme increased (7.5%) and nausea (7.5%). A report can list several reactions, so shares add to more than 100%; 318 different terms appear across these reports. Fatigue is recorded in 9% of these reports, against 3.7% of all reports in the database.
40.1% of the reports are marked serious by the reporter; 4.7% record death among the outcomes and 24.5% record hospitalisation, as reported. 83.5% of the reports came from consumers, and the largest patient age group is 18 to 44 (22.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Skyclarys reports recording the termall reports in the database
- Fatiguetiredness9%146
- Hepatic enzyme increasedraised liver enzymes7.5%122
- Nauseafeeling sick7.5%122
- Product dose omission issuea dose was missed6.5%106
- Headachehead pain6%97
- Diarrhoealoose or frequent stools5.5%89
- Blood cholesterol increasedraised cholesterol5.1%82
- Muscle spasmsmuscle cramps4.6%74
- Falla fall4.3%69
- Alanine aminotransferase increasedraised liver enzyme (ALT)3.8%62
- Urinary tract infectionbladder or urinary infection3.7%60
- Atrial fibrillationan irregular heart rhythm3.5%57
- Abdominal pain upperupper stomach pain3.5%56
- Vomitingbeing sick3.3%53
- Deaththe patient died; cause not stated by this term3.2%52
- Friedreich's ataxia3%48
- Astheniaweakness or lack of energy2.8%46
- Myalgiamuscle pain2.7%43
- Dizzinesslight-headedness or unsteadiness2.5%41
- Painpain, site not specified2.5%41
- Abdominal discomfortstomach discomfort2.5%40
- Aspartate aminotransferase increasedraised liver enzyme (AST)2.5%40
- Decreased appetitereduced appetite2.4%39
- Constipationconstipation2.3%38
- Pain in extremitypain in an arm or leg2.3%37
- Speech disordera speech problem2.2%36
- Back painback pain2.2%35
- Brain natriuretic peptide increased2.2%35
- Influenzaflu2.2%35
- Pneumonialung infection2.2%35
Top 30 of 318 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 96.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Friedreich's ataxia | 1,325 | 81.7% |
| Cerebellar ataxia | 3 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,622 reports.
In context
| Measure | Skyclarys | All reports |
|---|---|---|
| Reports as suspect product | 1,622 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 539 | 1,332,454 |
| Marked serious | 40.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 47 | 91 |
| Hospitalisation recorded, per 1,000 reports | 245 | 213 |
| Consumer-filed share | 83.5% | 45.8% |
| Top term, share of reports | Fatigue 9% | 3.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Skyclarys reports
How many adverse event reports has FDA received for Skyclarys?
1,622 reports list Skyclarys as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 539 of them arrived in the latest 12 months. Another 2 list it only as a concomitant medication.
What reactions are recorded in Skyclarys reports?
fatigue (9%), hepatic enzyme increased (7.5%), nausea (7.5%), product dose omission issue (6.5%) and headache (6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Skyclarys was responsible.
How serious are the reports?
40.1% are marked serious by the reporter. Among the outcomes recorded, 4.7% of reports include death and 24.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (83.5%), physician (10.7%) and other health professional (4.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Skyclarys rising?
539 reports in the 12 months to June 2026, close to the 583 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Skyclarys was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Skyclarys?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Skyclarys as a suspect or interacting product; reports listing it only as a concomitant medication (2) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.