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 | |
---|---|---|
1 | Fungal infection | 811 |
2 | Weight decreased | 493 |
3 | Urinary tract infection | 337 |
4 | Drug ineffective | 326 |
5 | Dizziness | 307 |
6 | Blood glucose increased | 290 |
7 | Pollakiuria | 245 |
8 | Nausea | 231 |
9 | Rash | 226 |
10 | Dehydration | 224 |
11 | Diabetic ketoacidosis | 192 |
12 | Drug dose omission | 185 |
13 | Genital infection fungal | 165 |
14 | Off label use | 163 |
15 | Diarrhoea | 150 |
16 | Urine output increased | 147 |
17 | Glomerular filtration rate decreased | 125 |
18 | Fatigue | 123 |
19 | Adverse event | 119 |
20 | Glycosylated haemoglobin increased | 116 |
* 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 | |
---|---|---|
1 | Type 2 diabetes mellitus | 6139 |
2 | Product used for unknown indication | 3154 |
3 | Diabetes mellitus | 2545 |
4 | Type 1 diabetes mellitus | 236 |
5 | Blood glucose increased | 107 |
6 | Diabetes mellitus inadequate control | 43 |
7 | Blood glucose abnormal | 38 |
8 | Weight decreased | 37 |
9 | Glycosylated haemoglobin increased | 33 |
10 | Hyperglycaemia | 15 |
*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.