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|
|8||Incorrect product storage||203|
|12||Urinary tract infection||178|
|17||Inappropriate schedule of drug administration||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|
|2||Product used for unknown indication||4443|
*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.
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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.