Cimziacertolizumab pegol
According to the FDA label: CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult…
114,572 adverse event reports submitted to the FDA (1991–2026)
Top Reported Adverse Events
The most frequently reported events in association with Cimzia in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 26,772 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Rheumatoid Arthritis 19,436 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Pain 15,698 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fatigue 13,479 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 11,345 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Rash 10,935 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 10,779 reports
Alopecia 10,079 reports
Joint Swelling 9,728 reports
Swelling in or around a joint.
Full definition in the glossary →Abdominal Discomfort 9,492 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →Maternal Exposure During Pregnancy 9,443 reports
A report noting that a pregnant person was exposed to a medication. This is a tracking category for monitoring use during pregnancy, not a description of harm by itself.
Full definition in the glossary →Systemic Lupus Erythematosus 9,041 reports
An autoimmune condition, often called lupus, where the immune system attacks the body's own tissues, affecting joints, skin, and organs. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Pemphigus 8,638 reports
A rare autoimmune condition that causes blistering of the skin and the moist linings of the body such as the mouth.
Full definition in the glossary →Drug Intolerance 8,629 reports
A report that the person could not tolerate a medication, often due to uncomfortable effects.
Full definition in the glossary →Swelling 8,628 reports
A general report of a body part becoming enlarged, often from fluid or inflammation.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 83,648 |
| Male | 20,477 |
| Unknown | 180 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,380 |
| 18-34 | 8,613 |
| 35-49 | 17,931 |
| 50-64 | 17,511 |
| 65-74 | 6,763 |
| 75+ | 2,717 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Cimzia. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 62,194 |
| Non-Serious | 40,467 |
| Hospitalization | 21,033 |
| Disability | 7,544 |
| Death | 6,313 |
| Life-Threatening | 5,573 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Cimzia. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1991 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 29 |
| 2009 | 2,235 |
| 2010 | 3,589 |
| 2011 | 3,494 |
| 2012 | 1,594 |
| 2013 | 1,751 |
| 2014 | 1,658 |
| 2015 | 2,889 |
| 2016 | 5,758 |
| 2017 | 4,121 |
| 2018 | 5,052 |
| 2019 | 12,584 |
| 2020 | 10,670 |
| 2021 | 10,545 |
| 2022 | 11,787 |
| 2023 | 10,488 |
| 2024 | 12,708 |
| 2025 | 12,085 |
| 2026 (partial) | 1,530 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Cimzia
In FDA adverse event reports that mention Cimzia, these medications appeared most often in the same report.
- Methotrexate (29,632 reports)
- Adalimumab (23,311 reports)
- Etanercept (22,988 reports)
- Prednisone (20,894 reports)
- Leflunomide (20,831 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026