FDA Adverse Events Reports (FAERS) Summary for LEQSELVI

These tables and charts are based on 55 total reports for LEQSELVI (DEURUXOLITINIB PHOSPHATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

Top 20 Adverse Effects Associated with LEQSELVI (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	PRODUCT USE ISSUE	12
2	PRODUCT DOSE OMISSION ISSUE	10
3	DRUG INEFFECTIVE	8
4	THERAPY CESSATION	8
5	ACNE	5
6	HEADACHE	4
7	CONDITION AGGRAVATED	3
8	FATIGUE	3
9	COMMON COLD	3
10	ITCHING	3
11	ABDOMINAL PAIN UPPER	2
12	JOINT PAIN	2
13	HAIR LOSS	1
14	BLOOD CHOLESTEROL INCREASED	1
15	BLOOD CREATINE PHOSPHOKINASE INCREASED	1
16	STROKE	1
17	CHILLS	1
18	COLITIS	1
19	COUGH	1
20	DEATH	1
21	DRUG INTOLERANCE	1
22	DRY MOUTH	1
23	GAIT DISTURBANCE	1
24	HYPERSENSITIVITY	1
25	NUMBNESS	1
26	INFECTIOUS MONONUCLEOSIS	1
27	INSOMNIA	1
28	INTENTIONAL DOSE OMISSION	1
29	JOINT SWELLING	1
30	MIGRAINE	1
31	NASAL CONGESTION	1
32	NAUSEA	1
33	OFF LABEL USE	1
34	PLATELET COUNT INCREASED	1
35	PULMONARY EMBOLISM	1
36	RESPIRATORY TRACT INFECTION	1
37	THERAPY INTERRUPTED	1
38	RINGING IN THE EARS	1
39	TREATMENT NONCOMPLIANCE	1
40	WEIGHT INCREASED	1
41	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	1

Latest Known Outcomes for Reactions Reported for LEQSELVI

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	53
2	Patient recovered	3
3	Patient is recovering/symptoms resolving	1
4	Patient has not recovered/symtoms have not resolved	1
5	Patient died	1

Search all MedWatch and FAERS by keyword:

LEQSELVI Total Reports

Male	Female	Unknown	Total
18	32		55

Top Countries Reporting

	Country	Number of Reports
1	United States	55

Outcomes for Reports

Serious: 4
Not Serious: 51
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2024-07-25

LEQSELVI (DEURUXOLITINIB) Rx Drug:
Risk of low blood sugar (hypoglycemia) in patients with diabetes. Safety-related Labeling Changes

Have experience (good or bad) with LEQSELVI? Rate LEQSELVI at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for LEQSELVI reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.