What the label lists and what reports show
Levoketoconazole side effects
Levoketoconazole's FDA label: “Most common adverse reactions (incidence > 20%) are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory …” FAERS holds 694 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (237 reports).
- No generic listed
- Boxed warning
Check it at the source: the levoketoconazole FDA label on DailyMed (effective March 10, 2026, Xeris Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of RECORLEV?RECORLEV may cause serious side effects, including: See "What is the most important information I should know about RECORLEV?” Hypersensitivity reactions. Serious allergic reactions can happen in people who take RECORLEV. Call your healthcare provider right away, or visit an emergency center, if you get a rash, itching, hives, fever, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. Risks related to decreased testosterone. RECORLEV may lower testosterone levels in males and females. Call your healthcare provider if you have any of these symptoms: Males: breast enlargement (gynecomastia) and erectile dysfunction (impotence) Females: low desire for sex (decreased libido) and mood changes. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 20%) are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
Table 3: Adverse Reactions, Excluding Hepatic Injury, Occurring in ≥10% of Cushing’s Syndrome Patients Treated with RECORLEV in Study 2
| Adverse Reaction Type | N = total number of patients, n = number of patients experiencing the event, (%) =… a Erythema includes flushing. b Hemorrhage/Contusion includes blood urine present, conjunctival hemorrhage, ecchymosis,… c Abdominal pain/dyspepsia includes abdominal discomfort, abdominal distension,… d Arrhythmia includes bradycardia, carotid pulse increased, defect conduction… N = 94 n (%) |
|---|---|
| Erythema a | 40 (43%) |
| Hemorrhage/Contusion b | 38 (40%) |
| Fatigue | 37 (39%) |
| Headache | 36 (38%) |
| Nausea/Vomiting | 35 (37%) |
| Abdominal pain/dyspepsia c | 31 (33%) |
| Arthritis | 26 (28%) |
| Upper respiratory infection | 26 (28%) |
| Myalgia | 24 (26%) |
| Abnormal uterine bleeding | 23 (24%) |
| Arrhythmia d | 23 (24%) |
| Back pain | 21 (22%) |
| Insomnia/Sleep disturbances | 21 (22%) |
| Peripheral edema | 19 (20%) |
| Systemic hypertension | 19 (20%) |
| Diarrhea | 18 (19%) |
| Pre-Syncope/Syncope | 17 (18%) |
| Rash | 16 (17%) |
| Urinary tract infection | 15 (16%) |
| Hypokalemia | 14 (15%) |
| Pruritus | 14 (15%) |
| Disturbance in attention | 13 (14%) |
| Irritability | 13 (14%) |
| Depression | 11 (12%) |
| Dry skin | 11 (12%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Hypocortisolism [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Risks related to Decreased Testosterone [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 20%) are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of RECORLEV was evaluated in a multicenter, randomized-withdrawal study (Study 1) and in a multicenter, single-arm, open-label study (Study 2). …
Source: FDA drug label, 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?
694 reports list levoketoconazole among the medicines taken, 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. Of the 23 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Levoketoconazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions