Drug Safety Information for XARELTO (Rivaroxaban)

Safety-related Labeling Changes for XARELTO (RIVAROXABAN) Rx Drug: FDA Link

Required post-approval safety study:

Conduct a dose-exploration, multicenter clinical trial evaluating the multiple dose PK/PD profile and safety of oral rivaroxaban (oral suspension) in pediatric patients aged birth to <6 months with VTE. Due Date: 2020-12-31

Required post-approval safety study:

Conduct a single-dose PK/PD and tolerability trial in pediatric patients age birth to < 6 months with VTE to determine doses of rivaroxaban (oral suspension) that provide similar exposure and/or PD effect to those seen in older pediatric cohorts. Due Date: 2020-06-30

Required post-approval safety study:

Conduct a randomized, active-controlled, multicenter clinical trial evaluating the safety, efficacy and PK/PD (sparse sampling) of at least 3 months of treatment with oral rivaroxaban (tablets or oral suspension) in pediatric patients aged birth to < 17 years of age who have acute VTE. Patients who require treatment for longer than 3 months will be offered continuation of treatment in an open label extension of this study with treatment duration of up to 12 months. Patients from birth to <6 months of age may be enrolled only after data from a planned interim analysis have shown efficacy and safety of rivaroxaban in the older pediatric age groups. Age distribution of patients in the study should reflect the occurrence of VTE in the pediatric population. Due Date: 2023-06-30

Required post-approval safety study:

Original FDA Drug Approval Date for XARELTO: 2011-07-01

Adverse Drug Reactions for XARELTO* (Rivaroxaban)

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 XARELTO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Gastrointestinal haemorrhage	2415
2	Pulmonary embolism	2075
3	Deep vein thrombosis	1813
4	Haemorrhage	1624
5	Drug ineffective	1363
6	Cerebrovascular accident	1273
7	Epistaxis	1115
8	Haemoglobin decreased	1100
9	Dyspnoea	1010
10	Thrombosis	936
11	Anaemia	936
12	Fall	891
13	Dizziness	868
14	Fatigue	765
15	Death	734
16	Asthenia	712
17	Inappropriate schedule of drug administration	707
18	Nausea	707
19	Headache	694
20	Haematuria	681

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

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

	Reason	# of FDA Reports
1	Atrial fibrillation	28757
2	Product used for unknown indication	15098
3	Pulmonary embolism	5377
4	Deep vein thrombosis	4678
5	Thrombosis prophylaxis	4489
6	Embolism venous	2639
7	Knee arthroplasty	2305
8	Anticoagulant therapy	2253
9	Thrombosis	2147
10	Hip arthroplasty	1348

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

Types of Adverse Events for XARELTO

Total Reports Filed with FDA: 84940

Number of FDA Adverse Event Reports by Patient Age for XARELTO

Total Reports Filed with FDA: 84940*

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

Charts are based on 84940 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.