JANUMET XR FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 134 U.S. reports for JANUMET XR (METFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE) 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 JANUMET XR Report.

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

	Side Effect	# of FDA Reports
1	FATIGUE	11
2	THERAPY INTERRUPTED	9
3	LACK OF STRENGTH AND ENERGY (ASTHENIA)	8
4	BLOOD GLUCOSE INCREASED	7
5	DIABETIC KETOACIDOSIS	7
6	DIARRHEA	7
7	ABDOMINAL PAIN UPPER	6
8	BALANCE DISORDER	6
9	STROKE	6
10	DIZZINESS	6
11	HEADACHE	6
12	NAUSEA	6
13	VISION BLURRED	6
14	JOINT PAIN	5
15	DEATH	5
16	RECALLED PRODUCT ADMINISTERED	5
17	BLOOD MAGNESIUM DECREASED	4
18	DRUG INEFFECTIVE	4
19	EYE INFECTION	4
20	FALL	4
21	IMPAIRED WORK ABILITY	4
22	PRODUCT SUBSTITUTION ISSUE	4
23	FEVER	4
24	RASH	4
25	SEPSIS	4

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JANUMET XR Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
55	73	6	134

Medwatch Reporter Type	Count
Consumer	42
Physician	5
Pharmacist	26
Other Health Professional	34

Top Indications

Diabetes mellitus
Type 2 diabetes mellitus

Type of Outcome Reported
Serious: 104
Not Serious: 30
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: 134
Concomitant Drugs: 114
Note: A single MedWatch report can list more than one drug. This summary includes JANUMET XR identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

JANUMET XR (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE) Rx Drug:
FDA Safety-related Labeling Changes

Risk of lactic acidosis in patients with mitochondrial diseases; it is NOT recommended that patients with these diseases take metformin-containing medications.

Have experience (good or bad) with JANUMET XR? Rate JANUMET XR 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.