Drug Safety Information for ENBREL (Etanercept)

Safety-related Labeling Changes for ENBREL (ETANERCEPT) Rx Drug: FDA Link

Safety-related Labeling Changes for ERELZI (ETANERCEPT-SZZS) Biological Drug: FDA Link

Required post-approval safety study:

Enhanced pharmacovigilance program for reports of malignancy in pediatric, adolescent, and young adult (less than or equal to 30 years of age) patients treated with Enbrel (etanercept), for a period of up to 10 years to collect data that will be analyzed to better define the risk of this serious adverse event. The enhanced pharmacovigilance program includes the following: 1) active query of reporters to obtain additional clinical information related to malignancy diagnoses 2) expedited reporting to FDA of all initial and follow-up reports of any malignancy in pediatric, adolescent, and young adult patients. Due Date: 2020-03-31

Original FDA Drug Approval Date for ENBREL: 1998-11-02

Adverse Drug Reactions for ENBREL* (Etanercept)

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 ENBREL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Injection site pain	37893
2	Injection site erythema*	28443
3	Arthralgia*	20881
4	Injection site swelling	16168
5	Psoriasis	16133
6	Injection site pruritus	14732
7	Injection site haematoma	14176
8	Drug ineffective	13808
9	Pain in extremity	13440
10	Injection site reaction	13291
11	Rheumatoid arthritis	12910
12	Pain*	12256
13	Headache*	11302
14	Fatigue*	10600
15	Nasopharyngitis	9134
16	Injection site warmth	7750
17	Sinusitis*	7598
18	Cough	7364
19	Joint swelling	6953
20	Nausea	6945

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

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

	Reason	# of FDA Reports
1	Rheumatoid arthritis*	429201
2	Psoriatic arthropathy*	121098
3	Psoriasis*	96765
4	Product used for unknown indication	53524
5	Ankylosing spondylitis*	45256
6	Juvenile arthritis*	13677
7	Arthritis*	1681
8	Systemic lupus erythematosus	1155
9	Polyarthritis	1037
10	Spondyloarthropathy	786

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

Types of Adverse Events for ENBREL

Total Reports Filed with FDA: 786615

Number of FDA Adverse Event Reports by Patient Age for ENBREL

Total Reports Filed with FDA: 786615*

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

Charts are based on 786615 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.