Drug Safety Information for SIMPONI (Golimumab)

Safety-related Labeling Changes for SIMPONI (GOLIMUMAB) Biological Drug: FDA Link

Safety-related Labeling Changes for SIMPONI ARIA (GOLIMUMAB) 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 Simponi (golimumab), 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 SIMPONI: 2009-04-24

Adverse Drug Reactions for SIMPONI* (Golimumab)

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 SIMPONI
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug dose omission	1506
2	Device malfunction	1184
3	Drug ineffective	626
4	Pneumonia	515
5	Pain	308
6	Arthralgia	275
7	Rheumatoid arthritis	226
8	Incorrect product storage	203
9	Fatigue	192
10	Headache	189
11	Dyspnoea	186
12	Urinary tract infection	178
13	Malaise	177
14	Nausea	173
15	Infection	172
16	Dizziness	154
17	Inappropriate schedule of drug administration	154
18	Cellulitis	154
19	Pain in extremity	154
20	Therapeutic response decreased	153

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

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

	Reason	# of FDA Reports
1	Rheumatoid arthritis	11029
2	Product used for unknown indication	4443
3	Psoriatic arthropathy	2432
4	Ankylosing spondylitis	2206
5	Colitis ulcerative	1219
6	Psoriasis	222
7	Crohn's disease	201
8	Arthritis	185
9	Spondylitis	122
10	Juvenile arthritis	90

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

Types of Adverse Events for SIMPONI

Total Reports Filed with FDA: 24696

Number of FDA Adverse Event Reports by Patient Age for SIMPONI

Total Reports Filed with FDA: 24696*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Golimumab (Simponi aria, Simponi)

Charts are based on 24696 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.