Drug Safety Information for FARXIGA (Dapagliflozin)

Safety-related Labeling Changes for FARXIGA (DAPAGLIFLOZIN) Rx Drug: FDA Link

Safety-related Labeling Changes for XIGDUO XR (DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for QTERN (DAPAGLIFLOZIN PROPANEDIOL; SAXAGLIPTIN HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for QTERNMET XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE) Rx Drug: FDA Link

Required post-approval safety study:

Conduct a 26-week randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the monotherapies saxagliptin and dapagliflozin 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 either metformin, insulin, or metformin plus insulin. A second randomization will take place at week 14, with uptitration of dose (saxagliptin may be increased from 2.5 mg to 5 mg dapagliflozin from 5 mg to 10 mg) for approximately half of the subjects with a hemoglobin A1C greater than or equal to 7%. Due Date: 2022-04-30

Required post-approval safety study:

An enhanced pharmacovigilance study of ketoacidosis in patients treated with dapagliflozin. 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 dapagliflozin, with specialized follow-up to collect additional information on these cases. Due Date: 2021-12-31

Original FDA Drug Approval Date for FARXIGA: 2014-01-08

Adverse Drug Reactions for FARXIGA* (Dapagliflozin)

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 FARXIGA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fungal infection164
2Weight decreased120
3Blood glucose increased92
4Nausea69
5Drug ineffective64
6Dizziness63
7Rash61
8Pollakiuria60
9Diarrhoea58
10Urinary tract infection56
11Dehydration43
12Headache39
13Vomiting37
14Fatigue36
15Drug dose omission36
16Pruritus35
17Diabetic ketoacidosis35
18Blood glucose decreased32
19Thirst30
20Glycosylated haemoglobin increased27

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus1801
2Diabetes mellitus319
3Product used for unknown indication216
4Glycosylated haemoglobin increased51
5Type 1 diabetes mellitus48
6Blood glucose increased25
7Diabetes mellitus inadequate control20
8Glucose tolerance impaired13
9Eosinophilia9
10Chills9

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


Types of Adverse Events for FARXIGA

Total Reports Filed with FDA: 3529


Number of FDA Adverse Event Reports by Patient Age for FARXIGA

Total Reports Filed with FDA: 3529*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dapagliflozin (Farxiga)

Charts are based on 3529 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.

Click to go back to search results and FARXIGA Reviews and Review Summary .

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.