Drug Safety Information for ELIQUIS (Apixaban)

Safety-related Labeling Changes for ELIQUIS (APIXABAN) Rx Drug: FDA Link

Required post-approval safety study:

Conduct a randomized, open-label, active-controlled, safety and descriptive efficacy study to assess apixaban treatment in 150 pediatric patients evaluable for efficacy and safety, aged 0 to less than 18 years, requiring anticoagulation for the treatment of a venous thromboembolic event (VTE). This trial will also evaluate apixaban pharmacokinetics, anti-Factor Xa activity, and imaging assessment of clot status at the end of treatment in pediatric patients requiring anticoagulation for the treatment of a VTE. Completion and submission of results of Study CV185325 may be used to fulfill this requirement. Due Date: 2021-10-18

Required post-approval safety study:

Assess apixaban pharmacokinetics and pharmacodynamics in approximately 50 pediatric subjects aged 0 to less than 18 years, who are at risk for a venous or arterial thrombotic disorder, to determine dosing requirements for subsequent studies in children. Completion and submission of results of Study CV185118 and available data from CV185079 may be used to fulfill this requirement. Due Date: 2020-12-31

Original FDA Drug Approval Date for ELIQUIS: 2012-12-28

Adverse Drug Reactions for ELIQUIS* (Apixaban)

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 ELIQUIS
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Gastrointestinal haemorrhage	352
2	Haemorrhage	336
3	Dizziness	282
4	Cerebrovascular accident	264
5	Dyspnoea	245
6	Rash	231
7	Atrial fibrillation	229
8	Fall	229
9	Death	216
10	Headache	210
11	Epistaxis	203
12	Diarrhoea	187
13	Drug interaction	185
14	Nausea	180
15	Pruritus	179
16	Contusion	174
17	Fatigue	168
18	Arthralgia	164
19	Asthenia	148
20	Adverse event	142

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

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

	Reason	# of FDA Reports
1	Cerebrovascular accident prophylaxis	3507
2	Atrial fibrillation	2425
3	Product used for unknown indication	2343
4	Thrombosis prophylaxis	1410
5	Embolism	310
6	Anticoagulant therapy	259
7	Cerebrovascular accident	116
8	Knee arthroplasty	116
9	Deep vein thrombosis	86
10	Hip arthroplasty	81

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

Types of Adverse Events for ELIQUIS

Total Reports Filed with FDA: 16764

Number of FDA Adverse Event Reports by Patient Age for ELIQUIS

Total Reports Filed with FDA: 16764*

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

Charts are based on 16764 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.