Omaveloxolone side effects: what 1,684 FDA adverse event reports show

Omaveloxolone · Skyclarys · 36 reaction terms · 882 drug–reaction co-reports · data 2026-09-14

Drug class

Cytochrome P450 3A4 Inducers, Cytochrome P450 2C8 Inducers

FDA label (mechanism-of-action class)

Brand names

Skyclarys

openFDA label

Who reports

1,684 reports · 43% serious · 80 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. ( 1 )

FDA label, Indications and Usage

What it is

SKYCLARYS contains omaveloxolone in immediate release capsules for oral administration available in a 50 mg strength.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 21 strongest signals

Labeled adverse reaction 2Labeled (related wording) 7Reporting / coding artifact 4Not in label — unassessed 8

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic enzyme increased	123	22.4 18.9–26.6ROR 24.1 · χ² 2,500 / p <1e-300	22.3 EB05 19.2 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2 · 89% consumer	no trial data cached
Blood cholesterol increased	82	21.8 17.6–26.9ROR 22.8 · χ² 1,606 / p <1e-300	21.7 EB05 18.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5 · 88% consumer	no trial data cached
Hepatic cytolysis	21	21.3 13.9–32.6ROR 21.5 · χ² 386 / p 4e-86	20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.8 · 100% clinician	no trial data cached
Blood triglycerides increased	22	15.4 10.1–23.3ROR 15.6 · χ² 281 / p 2e-63	14.9 EB05 10.0 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.9	no trial data cached
Cardiomyopathy	17	14.2 8.9–22.8ROR 14.4 · χ² 196 / p 8e-45	13.4 EB05 8.3 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.4	no trial data cached
Alanine aminotransferase increased	64	12.9 10.1–16.4ROR 13.4 · χ² 692 / p 8e-153	12.7 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	no trial data cached
Liver function test increased	22	12.8 8.4–19.3ROR 12.9 · χ² 227 / p 1e-51	12.1 EB05 8.0 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.1 · 73% consumer	no trial data cached
Prescribed underdose	20	12.4 8.0–19.2ROR 12.6 · χ² 199 / p 2e-45	11.6 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 85% consumer	no trial data cached
Cardiogenic shock	13	11.3 6.6–19.4ROR 11.4 · χ² 112 / p 2e-26	9.7 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Brain fog	13	11.0 6.4–19.0ROR 11.1 · χ² 109 / p 9e-26	9.4 EB05 5.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Aspartate aminotransferase increased	41	9.6 7.1–12.9ROR 9.8 · χ² 306 / p 7e-69	9.1 EB05 6.8 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.5	no trial data cached
Coordination abnormal	10	8.8 4.7–16.3ROR 8.9 · χ² 62 / p 2e-15	6.9 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Speech disorder	37	8.7 6.4–12.0ROR 8.9 · χ² 246 / p 8e-56	8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 92% consumer	no trial data cached
Atrial fibrillation	65	8.2 6.5–10.5ROR 8.5 · χ² 408 / p 4e-91	7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.5 · 78% consumer	no trial data cached
Gastroenteritis viral	12	8.2 4.7–14.4ROR 8.3 · χ² 69 / p 5e-17	6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Product dose omission in error	13	6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Cardiac failure (heart failure)	36	5.5 4.0–7.7ROR 5.6 · χ² 130 / p 2e-30	5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.5	no trial data cached
Underdose	28	4.7 3.3–6.8ROR 4.8 · χ² 79 / p 3e-19	4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 93% consumer	no trial data cached
Laboratory test abnormal	11	4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 9.4	no trial data cached
Product dose omission issue	106	4.6 3.8–5.5ROR 4.8 · χ² 300 / p 2e-67	4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 99% consumer	no trial data cached
Cardiac disorder	32	4.2 3.0–5.9ROR 4.3 · χ² 76 / p 2e-18	4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.7 · 97% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic enzyme increased	123	22.4 18.9–26.6ROR 24.1 · χ² 2,500 / p <1e-300	22.3 EB05 19.2 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2 · 89% consumer	no trial data cached
Product dose omission issue	106	4.6 3.8–5.5ROR 4.8 · χ² 300 / p 2e-67	4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 99% consumer	no trial data cached
Blood cholesterol increased	82	21.8 17.6–26.9ROR 22.8 · χ² 1,606 / p <1e-300	21.7 EB05 18.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5 · 88% consumer	no trial data cached
Atrial fibrillation	65	8.2 6.5–10.5ROR 8.5 · χ² 408 / p 4e-91	7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.5 · 78% consumer	no trial data cached
Alanine aminotransferase increased	64	12.9 10.1–16.4ROR 13.4 · χ² 692 / p 8e-153	12.7 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	no trial data cached
Aspartate aminotransferase increased	41	9.6 7.1–12.9ROR 9.8 · χ² 306 / p 7e-69	9.1 EB05 6.8 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.5	no trial data cached
Speech disorder	37	8.7 6.4–12.0ROR 8.9 · χ² 246 / p 8e-56	8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 92% consumer	no trial data cached
Cardiac failure (heart failure)	36	5.5 4.0–7.7ROR 5.6 · χ² 130 / p 2e-30	5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.5	no trial data cached
Cardiac disorder	32	4.2 3.0–5.9ROR 4.3 · χ² 76 / p 2e-18	4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.7 · 97% consumer	no trial data cached
Underdose	28	4.7 3.3–6.8ROR 4.8 · χ² 79 / p 3e-19	4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 93% consumer	no trial data cached
Liver function test increased	22	12.8 8.4–19.3ROR 12.9 · χ² 227 / p 1e-51	12.1 EB05 8.0 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.1 · 73% consumer	no trial data cached
Blood triglycerides increased	22	15.4 10.1–23.3ROR 15.6 · χ² 281 / p 2e-63	14.9 EB05 10.0 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.9	no trial data cached
Hepatic cytolysis	21	21.3 13.9–32.6ROR 21.5 · χ² 386 / p 4e-86	20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.8 · 100% clinician	no trial data cached
Prescribed underdose	20	12.4 8.0–19.2ROR 12.6 · χ² 199 / p 2e-45	11.6 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 85% consumer	no trial data cached
Cardiomyopathy	17	14.2 8.9–22.8ROR 14.4 · χ² 196 / p 8e-45	13.4 EB05 8.3 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Hepatic cytolysis — n=21, PRR 21.3
Prescribed underdose — n=20, PRR 12.4
Speech disorder — n=37, PRR 8.7
Atrial fibrillation — n=65, PRR 8.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Omaveloxolone?

In FDA FAERS, the most frequently co-reported reaction terms for Omaveloxolone are hepatic enzyme increased, blood cholesterol increased, atrial fibrillation, alanine aminotransferase increased, aspartate aminotransferase increased, speech disorder. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Omaveloxolone have an FDA boxed warning?

No. The FDA label retrieved for Omaveloxolone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Omaveloxolone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 2709e870-df3d-f30f-e063-6394a90aeda1, effective 20260406; matched on openfda.generic_name.exact:"OMAVELOXOLONE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 36 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.