Drug Safety Information for SAVAYSA (Edoxaban tosylate)

FDA Safety-related Labeling Changes for SAVAYSA (EDOXABAN TOSYLATE) Rx Drug: Safety Information Link

Required post-approval safety study:

Perform, complete and submit the full study report for a phase 3 multicenter, randomized, active control study of edoxaban in pediatric patients with documented venous thromboembolism in accordance with your October 31, 2013 agreed upon Initial Pediatric Study Plan (iPSP). Due Date: 2022-06-30

Original FDA Drug Approval Date for SAVAYSA: 2015-01-08

Adverse Drug Reactions for SAVAYSA* (Edoxaban tosylate)

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 SAVAYSA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Epistaxis	11
2	Rash	7
3	Contusion	6
4	Haemoptysis	6
5	Gastrointestinal haemorrhage	6
6	Haematochezia	5
7	Nausea	5
8	Blood urine present	4
9	Cerebrovascular accident	4
10	Abdominal discomfort	3
11	Cough	3
12	Gingival bleeding	3
13	Rectal haemorrhage	3
14	Dizziness	3
15	Confusional state	2
16	Vomiting	2
17	Off label use	2
18	Thrombosis	2
19	Fatigue	2
20	Pallor	1

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	84
2	Atrial fibrillation	42
3	Anticoagulant therapy	4
4	Cardiac valve disease	3
5	Pulmonary embolism	3
6	Cerebrovascular accident prophylaxis	2
7	Deep vein thrombosis	2

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

Types of Adverse Events for SAVAYSA

Total Reports Filed with FDA: 140

Number of FDA Adverse Event Reports by Patient Age for SAVAYSA

Total Reports Filed with FDA: 140*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Edoxaban tosylate (Savaysa)

Charts are based on 140 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.