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Levoketoconazole Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 20, 2023.

Applies to levoketoconazole: oral tablet.

Warning

Oral route (Tablet)

HepatotoxicityCases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving levoketoconazole.Levoketoconazole 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 to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease.Evaluate liver enzymes prior to and during treatment. Interrupt levoketoconazole treatment immediately if signs of hepatotoxicity occur.QT ProlongationLevoketoconazole is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes.Coadministration of levoketoconazole with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated.Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment. Temporarily discontinue levoketoconazole if QTcF interval exceeds 500 msec.

Serious side effects of Levoketoconazole

Along with its needed effects, levoketoconazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levoketoconazole:

More common

Less common

Incidence not known

Other side effects of Levoketoconazole

Some side effects of levoketoconazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to levoketoconazole: oral tablet.

General

The most significant adverse reactions were hepatotoxicity, QT prolongation, and hypocortisolism.[Ref]

Hepatic

Level 2

Up to 27% of the patients had at least 1 liver-related adverse reaction.

Percentage of patients with elevations in AST or ALT:

-AST or ALT greater than the upper limit of normal (ULN): 45%

-AST or ALT greater than 3 times ULN (3 x ULN): 11%

-AST or ALT greater than 5 x ULN: 5%

-AST or ALT greater than 10 x ULN: 3%[Ref]

Very common (10% or more): Liver enzyme elevation (included elevated AST, elevated ALT, elevated alkaline phosphatase, elevated GGT; 20%)

Common (1% to 10%): Hepatic pain, drug-induced liver injury, liver disorders

Uncommon (0.1% to 1%): Hepatic steatosis

Ketoconazole:

-Postmarketing reports: Serious hepatotoxicity including hepatitis cholestatic, biopsy-confirmed hepatic necrosis, cirrhosis, hepatic failure including cases resulting in transplantation or death[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 24%), arrythmia (included ECG QT prolonged, ECG T wave abnormal, palpitations, sinus tachycardia, paroxysmal tachycardia, ventricular extrasystoles, bradycardia, carotid pulse increased, defect conduction intraventricular, heart rate increased, sinus bradycardia; up to 24%)

Frequency not reported: QTc interval prolongation[Ref]

Level 2

In general, 2.4% of the patients experienced QTcF greater than 500 msec, while 14.7% of patients experienced change-from-baseline QTcF greater than 60 msec.[Ref]

Endocrine

Very common (10% or more): Adrenal insufficiency (10%)

Common (1% to 10%): Hypocortisolism, gynecomastia, hypogonadism

Ketoconazole:

-Postmarketing reports: Adrenocortical insufficiency[Ref]

Dermatologic

Very common (10% or more): Erythema (included flushing; 43%), rash (17%), pruritus (15%), dry skin (up to 12%), alopecia (up to 11%)

Ketoconazole:

-Postmarketing reports: Acute generalized exanthematous pustulosis, photosensitivity[Ref]

Other

Very common (10% or more): Fatigue (up to 39%), peripheral edema (20%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 38%), presyncope/syncope (18%) dizziness (15%), disturbance in attention (14%)

Ketoconazole:

-Postmarketing reports: Reversible intracranial pressure increased (e.g., papilledema, fontanelle bulging in infants)[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 37%), abdominal pain/dyspepsia (included abdominal pain, abdominal distension, dyspepsia, gastric disorder, abdominal discomfort, gastritis, other related terms; up to 33%), diarrhea (up to 19%), dry mouth (11%)

Common (1% to 10%): Gastrointestinal infection[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 29%), decreased appetite (13%)[Ref]

Musculoskeletal

Very common (10% or more): Arthritis (28%), myalgia (26%), back pain (22%)[Ref]

Genitourinary

Very common (10% or more): Abnormal uterine bleeding (up to 24%), urinary tract infection (up to 16%)

Ketoconazole:

-Postmarketing reports: Erectile dysfunction, azoospermia[Ref]

Level 2

Azoospermia was reported with dosages higher than 200 or 400 mg daily.[Ref]

Psychiatric

Very common (10% or more): Insomnia/sleep disturbances (22%), irritability (14%), depression (12%)

Common (1% to 10%): Decreased libido[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (up to 28%)

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Ketoconazole:

-Postmarketing reports: Allergic conditions including anaphylactic shock, anaphylactic reaction, angioneurotic edema[Ref]

Hematologic

Very common (10% or more): Hemorrhage/contusion (included blood urine present, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemorrhoidal hemorrhage, melena, scleral hemorrhage, conjunctival hemorrhage, ecchymosis, hyphema, RBCs urine; up to 40%),

Ketoconazole:

-Postmarketing reports: Thrombocytopenia[Ref]

References

1. Product Information. Recorlev (levoketoconazole). Xeris Pharmaceuticals Inc. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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