Levoketoconazole
Levoketoconazole is a cortisol synthesis inhibitor used to treat Cushing's syndrome — a condition where the body makes too much cortisol — in adults who cannot have surgery or whose surgery did not work.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Recorlev carries a serious warning for two major risks: liver damage and abnormal heart rhythms.
Liver damage: Severe liver injury — including cases requiring liver transplant or resulting in death — has been reported with oral ketoconazole (the related compound) and with Recorlev itself. Some patients had no known liver disease before starting. Recorlev must not be used in people who already have significant liver disease. Liver enzyme blood tests are required before starting and regularly throughout treatment. Stop taking Recorlev and seek medical care right away if you develop yellowing skin or eyes, dark urine, or severe tiredness.
Heart rhythm changes (QT prolongation): Recorlev can prolong the QT interval — an electrical measurement of your heart's rhythm — in a dose-related way. This can lead to a life-threatening irregular heartbeat called torsades de pointes. Recorlev cannot be used with other medications that also prolong QT, or in people who already have a prolonged QT interval or a personal or family history of certain heart rhythm disorders. An ECG and electrolyte blood tests are required before and during treatment.
📖 Levoketoconazole: Patient Information Guide
A plain-language walkthrough of Levoketoconazole — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Levoketoconazole is approved for a specific hormonal condition in adults.
- Recorlev (levoketoconazole) tablets are indicated for the treatment of Cushing's syndrome in adults with endogenous hypercortisolemia (the body making too much cortisol on its own) — specifically when surgery is not an option or has not cured the condition.
- Recorlev is not approved to treat fungal infections; its safety and effectiveness for that purpose have not been established.
⚙️How it works▾
Levoketoconazole works by blocking several key enzymes — CYP11B1, CYP11A1, and CYP17A1 — that are essential steps in the body's process of making cortisol. By blocking these enzymes, it reduces the amount of cortisol the body produces. Because these same enzymes are involved in testosterone production, levoketoconazole can also lower testosterone levels in both men and women.
💊How it's taken▾
Recorlev tablets are taken by mouth twice daily, with or without food — food does not meaningfully change how much drug is absorbed. Your prescriber will start you at a low dose and increase it gradually every 2–3 weeks, guided by urine cortisol measurements and how well you tolerate the medication. Once your dose is stable, cortisol levels are monitored at least every 1–2 months.
- Take Recorlev at roughly the same times each day as directed by your prescriber
- If antacids are needed, take them at least 2 hours after your Recorlev dose to avoid reducing absorption
- Do not stop or adjust your dose without talking to your doctor first — if cortisol drops too low, your dose may need to be reduced or paused
🤒Side effects — in detail▾
The most common side effects reported with Recorlev include:
- Nausea or vomiting
- Fatigue
- Headache
- Low potassium levels (hypokalemia)
- High blood pressure
- Abnormal uterine bleeding
- Skin redness or flushing
- Abdominal pain or upset stomach
- Dizziness and diarrhea
- Joint or muscle aches
More serious reactions to watch for include liver injury (yellowing skin or eyes, dark urine, fatigue), dangerous heart rhythm changes (pounding or irregular heartbeat, fainting), and signs of too-low cortisol (extreme tiredness, nausea, dizziness, low blood pressure). Contact your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Liver damage: This is the most critical risk. Severe liver injury — including fatal cases and cases requiring liver transplant — has been reported. Liver tests must be done before starting Recorlev and monitored frequently throughout treatment. Stop Recorlev and seek immediate care if you develop jaundice (yellowing of skin or eyes), dark urine, or severe fatigue.
- Heart rhythm changes (QT prolongation): Recorlev can prolong the QT interval in a dose-dependent way, potentially causing life-threatening irregular heartbeats. An ECG is required before and during treatment. Low potassium and magnesium levels increase this risk and must be corrected before starting.
- Low cortisol (hypocortisolism / adrenal insufficiency): Because Recorlev lowers cortisol, it can sometimes lower it too much, causing adrenal insufficiency — a potentially life-threatening condition. Symptoms include nausea, vomiting, dizziness, fatigue, and low blood pressure. Monitor cortisol levels regularly and report symptoms promptly.
- Decreased testosterone: Recorlev may lower testosterone in men and women. Men may experience breast enlargement, impotence, or reduced sperm count. Women may experience decreased libido or mood changes. Tell your doctor if these occur.
- Hypersensitivity reactions: Allergic reactions including anaphylaxis (severe whole-body allergic reaction) have been reported with ketoconazole. Seek immediate medical help if you develop difficulty breathing, hives, or swelling of the face or throat.
🔀What it interacts with▾
Recorlev is a strong inhibitor of CYP3A4, an important liver enzyme, and also affects drug transporters — meaning it raises blood levels of many other medications. Always share your complete medication list with your doctor and pharmacist before starting Recorlev.
- QT-prolonging drugs (e.g., clarithromycin, pimozide, quinidine, methadone, dronedarone): contraindicated — combining these raises the risk of dangerous heart rhythm problems
- Sensitive CYP3A4 substrates (e.g., midazolam, simvastatin, lovastatin, tacrolimus, triazolam): contraindicated or not recommended — Recorlev can dramatically increase their blood levels
- Atorvastatin: Recorlev greatly increases atorvastatin levels; use the lowest possible dose and watch for muscle side effects
- Metformin: Recorlev raises metformin levels; monitor blood sugar, kidney function, and vitamin B12
- Strong CYP3A4 inhibitors (e.g., ritonavir, mifepristone): raise levoketoconazole levels and increase risk of side effects — avoid starting 2 weeks before and during Recorlev treatment
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, efavirenz): reduce Recorlev's effectiveness — avoid starting 2 weeks before and during treatment
- Antacids: reduce Recorlev absorption — take at least 2 hours after your Recorlev dose
- Proton pump inhibitors, H2 blockers, and sucralfate: impair Recorlev absorption — avoid use with Recorlev
- Alcohol: avoid excessive alcohol — it can cause a disulfiram-like reaction (flushing, rash, nausea, swelling, headache) and worsens liver risk
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Liver disease: Recorlev is contraindicated in people with cirrhosis, active liver disease, poorly controlled chronic liver disease, extensive liver metastases, or prior liver injury from ketoconazole or any azole antifungal that required stopping treatment
- Heart rhythm conditions: Contraindicated if you have a QTcF interval above 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome — including a first-degree family history
- Recurrent gallstones: Recorlev is contraindicated in people with recurrent symptomatic cholelithiasis (repeated painful gallstone episodes)
- Allergy: Do not take Recorlev if you have a known allergy to levoketoconazole, ketoconazole, or any ingredient in Recorlev
- Pregnancy: Animal studies showed fetal harm at doses similar to human doses. Discuss risks and benefits carefully with your doctor if you are pregnant or could become pregnant
- Breastfeeding: Do not breastfeed during Recorlev treatment or for at least one day after your final dose — the drug may pass into breast milk and could cause serious harm to a nursing infant
- Fertility: Recorlev may impair fertility in men and women by lowering testosterone levels
- Children: Safety and effectiveness in patients under 18 have not been established
- Older adults: Limited clinical trial data are available for adults 65 and older; use with caution and close monitoring
- Kidney impairment: Recorlev has not been formally studied in people with kidney impairment
🚑If you take too much▾
If too much Recorlev is taken, treatment is focused on supportive and symptomatic care. If the overdose was recent (within the first hour), activated charcoal may be given to help limit absorption. If you suspect an overdose, contact emergency services or a poison control center immediately.
📡Pharmacodynamics — effects in the body▾
Recorlev produces a dose-related increase in the QT interval — the heart's electrical recovery time — with the largest average increase observed at the highest approved doses. In clinical studies, a small number of patients developed QT intervals above the threshold requiring temporary treatment interruption. This effect on heart rhythm is one of the most carefully monitored aspects of Recorlev therapy.
🔬Pharmacokinetics — how your body processes it▾
After a single oral dose of Recorlev taken on an empty stomach, peak blood levels are reached in about 1.5 to 2 hours. Taking it with a high-fat meal delays the peak by about 2 hours but does not significantly change overall drug exposure, so it can be taken with or without food. The drug is highly protein-bound (about 99%) in the bloodstream. Levoketoconazole is eliminated with a half-life of roughly 3 to 6 hours, and the major route of clearance is through bile into the digestive tract, with a smaller portion excreted in urine. Because it is extensively metabolized by the liver (primarily via CYP3A4), people with liver impairment may clear it more slowly — which is one reason significant liver disease is a contraindication.
📦How to store it▾
Store RECORLEV at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).
📄 Written from Levoketoconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Levoketoconazole — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Recorlev used for — is it the same as a regular antifungal? ▾
How will I know if Recorlev is working? ▾
What side effects should I actually worry about versus ones I can manage at home? ▾
I take a lot of other medications. Is that going to be a problem? ▾
Can I drink alcohol while taking Recorlev? ▾
What do I need to know about Recorlev if I'm a woman who could get pregnant? ▾
Is Levoketoconazole available over the counter? ▾
When was Levoketoconazole first available? ▾
Who makes Levoketoconazole? ▾
💬 Answers drafted from Levoketoconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Levoketoconazole comes
Levoketoconazole is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Recorlev is indicated to treat Cushing's syndrome in adults whose body overproduces cortisol, when surgery is not an option or was not curative
- Recorlev is not approved for the treatment of fungal infections
- Recorlev tablets are taken by mouth twice daily, with or without food
- Recorlev dosing is started low and adjusted gradually every 2–3 weeks based on cortisol levels and tolerability — follow your prescriber's schedule exactly
- If antacids are needed while taking Recorlev, take them at least 2 hours after your Recorlev dose; avoid proton pump inhibitors, H2 blockers, and sucralfate
- Recorlev requires baseline and ongoing liver tests and ECG monitoring — do not skip these appointments
📊 Levoketoconazole across the U.S. market
How Levoketoconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Levoketoconazole is used
A general measure of how commonly Levoketoconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Levoketoconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Levoketoconazole prescribed? Of the 1,596 medications we measure, Levoketoconazole ranks #1,414 by Medicaid prescriptions — more than 11% of them.
Utilization by Levoketoconazole product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Levoketoconazole products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 9 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Levoketoconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 9 listed Levoketoconazole NDCs with Medicaid activity.
🔍 Compare Levoketoconazole products
A representative set of FDA-listed product records for Levoketoconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 150 mg | — | Lonza Tampa LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg | Oral | Xeris Pharmaceuticals, Inc. × 4 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 100 kg/100 kg | — | Esteve CDMO US, Inc. | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Piramal Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 35 kg/35 kg | — | Sthree Chemicals Private Limited | BULK INGREDIENT | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Levoketoconazole NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Levoketoconazole — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Levoketoconazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Levoketoconazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Levoketoconazole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Levoketoconazole belongs to the Cortisol Synthesis Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Xeris Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.