Levoketoconazole side effects: what 693 FDA adverse event reports show

Levoketoconazole · Recorlev · 27 reaction terms · 414 drug–reaction co-reports · data 2026-09-14

Drug class

Cortisol Synthesis Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Recorlev

openFDA label

Who reports

693 reports · 56% serious · 12 with death outcome · 79% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established.

FDA label, Indications and Usage

What it is

RECORLEV (levoketoconazole) tablets contain levoketoconazole as the active ingredient. Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole and is a cortisol synthesis inhibitor.

FDA label, Description section

Boxed warning

HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )].

FDA 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 16 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Reporting / coding artifact 4Lab value / disease marker 4Not in label — unassessed 6

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 11 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
Drug effect less than expected	50	107.5 82.3–140.5ROR 115.8 · χ² 5,156 / p <1e-300	103.0 EB05 81.2 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=27 · 100% consumer	no trial data cached
Brain fog	22	45.6 30.2–68.9ROR 47.1 · χ² 915 / p 2e-201	44.0 EB05 30.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 61.3 · 95% consumer	no trial data cached
Blood potassium increased	23	42.9 28.7–64.1ROR 44.3 · χ² 899 / p 8e-198	41.5 EB05 29.1 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 37.2 · 83% consumer	no trial data cached
Hypersomnia	20	21.1 13.7–32.5ROR 21.7 · χ² 364 / p 2e-81	20.7 EB05 14.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 23.6 · 100% consumer	no trial data cached
Unevaluable event	52	20.8 16.0–27.0ROR 22.4 · χ² 962 / p 2e-211	20.6 EB05 16.3 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.5 · 100% consumer	no trial data cached
Blood potassium decreased	20	20.1 13.0–31.0ROR 20.7 · χ² 344 / p 4e-77	19.7 EB05 13.3 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.3 · 95% consumer	no trial data cached
Middle insomnia	12	19.5 11.1–34.2ROR 19.8 · χ² 193 / p 4e-44	18.6 EB05 10.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.8	no trial data cached
Eructation (belching)	11	17.5 9.7–31.4ROR 17.7 · χ² 155 / p 7e-36	16.3 EB05 8.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Glycosylated haemoglobin increased	14	16.8 10.0–28.2ROR 17.1 · χ² 193 / p 4e-44	16.0 EB05 9.5 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 25.1	no trial data cached
Blood pressure abnormal	11	16.8 9.3–30.2ROR 17.0 · χ² 148 / p 2e-34	15.5 EB05 8.2 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 22.7	no trial data cached
Panic attack	15	12.4 7.5–20.5ROR 12.7 · χ² 147 / p 5e-34	11.2 EB05 6.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Therapeutic response unexpected	18	12.1 7.7–19.1ROR 12.4 · χ² 172 / p 1e-39	11.1 EB05 6.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 40.4	no trial data cached
Surgery	20	10.4 6.8–16.1ROR 10.7 · χ² 162 / p 3e-37	9.4 EB05 6.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.0 · ♀ 100% (drug 79%) · 90% consumer	no trial data cached
Blood glucose decreased	16	10.0 6.2–16.3ROR 10.2 · χ² 121 / p 2e-28	8.7 EB05 5.4 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9	no trial data cached
Crying	11	9.1 5.1–16.4ROR 9.2 · χ² 72 / p 1e-17	7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Blood glucose increased	49	7.8 6.0–10.3ROR 8.3 · χ² 288 / p 8e-65	7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.8 · 98% 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
Unevaluable event	52	20.8 16.0–27.0ROR 22.4 · χ² 962 / p 2e-211	20.6 EB05 16.3 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.5 · 100% consumer	no trial data cached
Drug effect less than expected	50	107.5 82.3–140.5ROR 115.8 · χ² 5,156 / p <1e-300	103.0 EB05 81.2 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=27 · 100% consumer	no trial data cached
Blood glucose increased	49	7.8 6.0–10.3ROR 8.3 · χ² 288 / p 8e-65	7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.8 · 98% consumer	no trial data cached
Blood potassium increased	23	42.9 28.7–64.1ROR 44.3 · χ² 899 / p 8e-198	41.5 EB05 29.1 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 37.2 · 83% consumer	no trial data cached
Brain fog	22	45.6 30.2–68.9ROR 47.1 · χ² 915 / p 2e-201	44.0 EB05 30.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 61.3 · 95% consumer	no trial data cached
Surgery	20	10.4 6.8–16.1ROR 10.7 · χ² 162 / p 3e-37	9.4 EB05 6.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.0 · ♀ 100% (drug 79%) · 90% consumer	no trial data cached
Blood potassium decreased	20	20.1 13.0–31.0ROR 20.7 · χ² 344 / p 4e-77	19.7 EB05 13.3 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.3 · 95% consumer	no trial data cached
Hypersomnia	20	21.1 13.7–32.5ROR 21.7 · χ² 364 / p 2e-81	20.7 EB05 14.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 23.6 · 100% consumer	no trial data cached
Therapeutic response unexpected	18	12.1 7.7–19.1ROR 12.4 · χ² 172 / p 1e-39	11.1 EB05 6.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 40.4	no trial data cached
Blood glucose decreased	16	10.0 6.2–16.3ROR 10.2 · χ² 121 / p 2e-28	8.7 EB05 5.4 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9	no trial data cached
Panic attack	15	12.4 7.5–20.5ROR 12.7 · χ² 147 / p 5e-34	11.2 EB05 6.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Glycosylated haemoglobin increased	14	16.8 10.0–28.2ROR 17.1 · χ² 193 / p 4e-44	16.0 EB05 9.5 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 25.1	no trial data cached
Middle insomnia	12	19.5 11.1–34.2ROR 19.8 · χ² 193 / p 4e-44	18.6 EB05 10.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.8	no trial data cached
Crying	11	9.1 5.1–16.4ROR 9.2 · χ² 72 / p 1e-17	7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Blood pressure abnormal	11	16.8 9.3–30.2ROR 17.0 · χ² 148 / p 2e-34	15.5 EB05 8.2 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 22.7	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.

Brain fog — n=22, PRR 45.6
Hypersomnia — n=20, PRR 21.1

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 Levoketoconazole?

In FDA FAERS, the most frequently co-reported reaction terms for Levoketoconazole are blood glucose increased, blood potassium increased, brain fog, blood potassium decreased, hypersomnia, blood glucose decreased. 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 Levoketoconazole have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )].

Do FAERS signals prove that Levoketoconazole 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 d4c5fead-bc4a-fb02-e053-2a95a90ae4fc, effective 20260310; matched on openfda.generic_name.exact:"LEVOKETOCONAZOLE")
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, 27 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.