Prescription medicine
Levoketoconazole Brand names: Recorlev
Levoketoconazole (Recorlev) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the levoketoconazole FDA label on DailyMed (effective March 10, 2026, Xeris Pharmaceuticals, Inc.); the NDA 214133 record on Drugs@FDA; every levoketoconazole label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 )].
RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )].
Evaluate liver enzymes prior to and during treatment. Interrupt RECORLEV treatment immediately if signs of hepatotoxicity occur [see Dosage and Administration ( 2.1 , 2.3 , 2.4 ), Warnings and Precautions ( 5.1 )]. QT Prolongation
RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageRECORLEV 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.
Forms and strengths
- 150 mg
Tablet.
On the market
- Earliest approval on file
- December 30, 2021 Recorlev, Strongbridge; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 2, 2040 Recorlev tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 694 through July 30, 2026
What is levoketoconazole used for?
From the label: indications and usageRECORLEV 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. RECORLEV is a cortisol synthesis inhibitor 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 ( 1 ) Limitations of Use RECORLEV is not approved for the treatment of fungal infections
FDA pharmacologic class: Cortisol Synthesis Inhibitor.
Source: FDA drug label (Recorlev), NDA214133 (Strongbridge), as published by Xeris Pharmaceuticals, Inc., effective March 10, 2026 (SPL set d4c5fead-bc4a-fb02-e053-2a95a90ae4fc), via openFDA; the full label on DailyMed
What does the patient leaflet for levoketoconazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RECORLEV?RECORLEV can cause serious side effects, including: Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take RECORLEV. Some people who are treated with ketoconazole, a medicine like the active ingredient in RECORLEV, had serious liver problems that required a liver transplant or led to death. Call your healthcare provider right away if you have any of the following signs or symptoms: pain on the upper right side of your stomach area (abdomen) associated with nausea unusual fatigue yellowing of your skin or the whites of your eyes (jaundice) unusual bruising or bleeding RECORLEV should not be used if you have any of the following conditions: cirrhosis active or poorly controlled liver disease frequent stones in your gallbladder (cholelithiasis) history of liver problems due to use of a drug Your healthcare provider will do liver tests before and during treatment with RECORLEV. Heart rhythm problems (QT prolongation). RECORLEV can cause a heart problem called QT interval prolongation, or QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Call your healthcare provider right away if you feel severe lightheadedness or if you faint during treatment with RECORLEV. Low blood electrolyte levels of potassium and magnesium can increase your chances of QT prolongation during treatment with RECORLEV. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and do blood tests to check your blood electrolyte levels before and during treatment with RECORLEV. RECORLEV should not be taken with certain other medicines that cause QT prolongation. Talk to your healthcare provider about the medicines you are taking before you start taking RECORLEV. Low cortisol levels (adrenal insufficiency). […]
From the patient leaflet: What should I avoid while taking RECORLEV?Drinking alcohol to excess while taking RECORLEV may increase your chances of having serious side effects.
From the patient leaflet: How should I store RECORLEV?Store RECORLEV at room temperature between 68°F to 77°F (20°C to 25°C). Keep RECORLEV and all medicines out of the reach of children.
Source: FDA drug label (Recorlev), NDA214133 (Strongbridge), as published by Xeris Pharmaceuticals, Inc., effective March 10, 2026 (SPL set d4c5fead-bc4a-fb02-e053-2a95a90ae4fc), via openFDA; the full label on DailyMed
Is there a generic for levoketoconazole (Recorlev)?
No generic levoketoconazole is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Recorlev tablets, the last expiring on March 2, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the levoketoconazole label say about other medicines?
The levoketoconazole label names 50 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | Concomitant use of RECORLEV with these substrates is contraindicated or not recommended ( 7.1 ) Atorvastatin: |
| Avanafil | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Bosutinib | drug interactions | … torsades de pointes, is contraindicated [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking … |
| Buspirone | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Carbamazepine | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Clarithromycin | drug interactions | … contraindicated [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 … |
| Cobimetinib | drug interactions | … Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors) … |
| Crizotinib | drug interactions | … Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors) … |
| Dabigatran | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Darifenacin | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Darunavir | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Digoxin | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Disopyramide | drug interactions | … Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone … |
| Dofetilide | drug interactions | … Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin … |
Every other medicine the levoketoconazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Dronedarone | drug interactions | … clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or … |
| Efavirenz | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Eliglustat | drug interactions | … b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 … |
| Everolimus | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone … |
| Fexofenadine | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone … |
| Fosamprenavir | drug interactions | Examples; Antivirals (e.g., ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, saquinavir) Glucocorticoid and progesterone receptor antagonists (e.g., mifepristone) |
| Ibrutinib | drug interactions | Examples; Alfentanil, avanafil, buspirone, conivaptan b, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone … |
| Isoniazid | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Ivabradine | drug interactions | … CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Ketoconazole | boxed warning | Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. |
| Lomitapide | drug interactions | … darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b … |
| Lovastatin | drug interactions | … digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam … |
| Lurasidone | drug interactions | … ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and … |
| Metformin | drug interactions | Use lowest atorvastatin dose possible and monitor for adverse reactions for dosages exceeding 20 mg daily ( 7.1 ) Metformin: |
| Methadone | drug interactions | … patients taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Midazolam | drug interactions | … everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Midostaurin | drug interactions | … taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Mifepristone | drug interactions | Examples; Antivirals (e.g., ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, saquinavir) Glucocorticoid and progesterone receptor antagonists (e.g., mifepristone) |
| Mitotane | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Naloxegol | drug interactions | … fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Nevirapine | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Nicardipine | drug interactions | … or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Nisoldipine | drug interactions | … ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Phenytoin | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Pimozide | drug interactions | … CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Quinidine | drug interactions | … inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Ranolazine | drug interactions | … ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine. |
| Rifabutin | drug interactions | Examples; Antibacterials (e.g., isoniazid, rifabutin, rifampicin) Anticonvulsants (e.g., carbamazepine, phenytoin) Antivirals (e.g., efavirenz, nevirapine) Cytotoxic agents (e.g., mitotane) |
| Ritonavir | drug interactions | Examples; Antivirals (e.g., ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, saquinavir) Glucocorticoid and progesterone receptor antagonists (e.g., mifepristone) |
| Simvastatin | drug interactions | … lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Sirolimus | drug interactions | … lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Sucralfate | drug interactions | Prevention or Management; Avoid use of sucralfate with RECORLEV. |
| Tacrolimus | drug interactions | … midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Testosterone | warnings and precautions | Anaphylaxis has been reported with oral ketoconazole ( 5.4 ) Risks Related to Decreased Testosterone: |
| Triazolam | drug interactions | … nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
| Vardenafil | drug interactions | … saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b, triazolam, and vardenafil. |
Source: FDA drug label (Recorlev), NDA214133 (Strongbridge), as published by Xeris Pharmaceuticals, Inc., effective March 10, 2026 (SPL set d4c5fead-bc4a-fb02-e053-2a95a90ae4fc), via openFDA; the full label on DailyMed
What do FAERS reports show for levoketoconazole?
The FDA Adverse Event Reporting System holds 694 reports that list levoketoconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 172 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cortisol synthesis inhibitors
- the pharmacologic class, with prices and generics
- Levoketoconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other