Drug Safety Information for INVOKANA (Canagliflozin)

Safety-related Labeling Changes for INVOKANA (CANAGLIFLOZIN) Rx Drug: FDA Link

Safety-related Labeling Changes for INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link

Required post-approval safety study:

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

Required post-approval safety study:

An assessment and analysis of all foreign and domestic spontaneous reports of malignancy (pheochromocytoma, Leydig cell tumor, and renal cell carcinoma), fatal pancreatitis, hemorrhagic/necrotizing pancreatitis, severe hypersensitivity reactions (angioedema, anaphylaxis, Stevens-Johnson syndrome), photosensitivity reactions, serious hepatic abnormalities, and pregnancy in patients treated with canagliflozin. The enhanced pharmacovigilance should continue for 10 years from the date of approval for malignancies and 5 years for all other events. Due Date: 2023-11-30

Original FDA Drug Approval Date for INVOKANA: 2013-03-29

Adverse Drug Reactions for INVOKANA* (Canagliflozin)

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 INVOKANA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fungal infection811
2Weight decreased493
3Urinary tract infection337
4Drug ineffective326
5Dizziness307
6Blood glucose increased290
7Pollakiuria245
8Nausea231
9Rash226
10Dehydration224
11Diabetic ketoacidosis192
12Drug dose omission185
13Genital infection fungal165
14Off label use163
15Diarrhoea150
16Urine output increased147
17Glomerular filtration rate decreased125
18Fatigue123
19Adverse event119
20Glycosylated haemoglobin increased116

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus6139
2Product used for unknown indication3154
3Diabetes mellitus2545
4Type 1 diabetes mellitus236
5Blood glucose increased107
6Diabetes mellitus inadequate control43
7Blood glucose abnormal38
8Weight decreased37
9Glycosylated haemoglobin increased33
10Hyperglycaemia15

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


Types of Adverse Events for INVOKANA

Total Reports Filed with FDA: 13100


Number of FDA Adverse Event Reports by Patient Age for INVOKANA

Total Reports Filed with FDA: 13100*


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

Charts are based on 13100 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 INVOKANA 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.