Drug Safety Information for SYNJARDY (Empagliflozin; metformin hydrochloride)

FDA Safety-related Labeling Changes for SYNJARDY (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

Conduct a 26-week randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of linagliptin and empagliflozin for the treatment of pediatric patients ages 10 to < 18 years with type 2 diabetes mellitus, followed by a 26-week site- and subject-blinded safety extension period (weeks 26 to 52). Background therapy will consist of metformin, insulin, or metformin plus insulin. A second randomization will take place at week 12, with uptitration of empagliflozin dose (from 10 mg to 25 mg) for approximately half of the subjects with a hemoglobin A1C greater than or equal to 7%. Due Date: 2022-12-31

Required post-approval safety study:

An enhanced pharmacovigilance study of ketoacidosis in patients treated with empagliflozin. The study will include reports of ketoacidosis or diabetic ketoacidosis for a period of 5 years, and will include assessment and analysis of spontaneous reports of ketoacidosis in patients treated with empagliflozin, with specialized follow-up to collect additional information on these cases. Due Date: 2021-12-31

Original FDA Drug Approval Date for SYNJARDY: 2015-08-26

Adverse Drug Reactions for SYNJARDY* (Empagliflozin; metformin hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SYNJARDY
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Staphylococcus test positive	1
2	White blood cell count decreased	1
3	Pyrexia	1
4	Neutropenia	1
5	Sepsis	1
6	Malaise	1
7	Herpes simplex dna test positive	1
8	Pneumonia	1
9	Streptococcus test positive	1
10	Mucosal inflammation	1
11	Cough	1
12	Respiratory tract congestion	1

* This side effect also appears in "Top 10 Side Effects of SYNJARDY " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SYNJARDY
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Diabetes mellitus	12

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for SYNJARDY

Total Reports Filed with FDA: 12

Number of FDA Adverse Event Reports by Patient Age for SYNJARDY

Total Reports Filed with FDA: 12*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Empagliflozin; metformin hydrochloride (Synjardy)

Charts are based on 12 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.