JARDIANCE FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 2,303 U.S. reports for JARDIANCE (EMPAGLIFLOZIN) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS JARDIANCE Report.

Top Adverse Events Reported with JARDIANCE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	NAUSEA	149
2	VOMITING	117
3	DIABETIC KETOACIDOSIS	110
4	DEATH	108
5	FUNGAL INFECTION	98
6	DIARRHEA	95
7	SHORTNESS OF BREATH	94
8	DIZZINESS	87
9	DRUG INEFFECTIVE	84
10	URINARY TRACT INFECTION	84
11	LACK OF STRENGTH AND ENERGY (ASTHENIA)	82
12	THERAPY CESSATION	81
13	THERAPY INTERRUPTED	79
14	FATIGUE	78
15	RASH	72
16	EUGLYCAEMIC DIABETIC KETOACIDOSIS	71
17	DEHYDRATION	69
18	FOURNIER^S GANGRENE	66
19	ITCHING	62
20	HEADACHE	55
21	BLOOD GLUCOSE INCREASED	54
22	FALL	52
23	PAIN	50
24	SEPSIS	46
25	ACUTE KIDNEY INJURY	44

Search all MedWatch Reports by Keyword:

JARDIANCE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
1125	1008	170	2,303

Medwatch Reporter Type	Count
Consumer	1193
Physician	99
Pharmacist	458
Other Health Professional	315

Top Indications

Product used for unknown indication
Type 2 diabetes mellitus
Diabetes mellitus
HEART FAILURE
Cardiac failure chronic

Type of Outcome Reported
Serious: 1754
Not Serious: 549
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 2303
Concomitant Drugs: 1715
Note: A single MedWatch report can list more than one drug. This summary includes JARDIANCE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

JARDIANCE (EMPAGLIFLOZIN) Rx Drug:
FDA Safety-related Labeling Changes

Jardiance increases the risk of genitourinary infections including urinary tract infections and genital mycotic infections in both male and female patients

Have experience (good or bad) with JARDIANCE? Rate JARDIANCE 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 U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. 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.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA 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 about this report.