This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric ...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
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 patients with active psoriatic arthritis. ( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ( 1.7 ) 1.1 Crohn's Disease CIMZIA is 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. 1.2 Rheumatoid Arthritis CIMZIA is indicated for the treatment of adults with moderately to severely active rheu...
is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria [see Warnings and Precautions (5.4) ] . Serious hypersensitivity reaction to certolizumab pegol or to any of the excipients. ( 4 )
Serious Infections : CIMZIA should not be initiated in patients with an active infection. Monitor for infection during and after treatment; discontinue if a serious infection develops. If invasive fungal infection develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungal therapy. ( 5.1 ) Malignancies : Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including CIMZIA. ( 5.2 ) Heart Failure : Monitor patients for new onset or worsening congestive heart failure. ( 5.3 ) Hypersensitivity Reactions : Discontinue CIMZIA and institute appropriate therapy if anaphylaxis or other serious hypersensitivity reactions occur. ( 5.4 ) Hepatitis B Virus Reactivation : Test for HBV infection before starting CIMZIA. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop CIMZIA and begin anti-viral therapy ( 5.5 ) Neurologic Reactions : Exacerbation or new onset demyelinating disease may occur; use caution in patients with pre-existing or recent-onset demyelinating disorders. ( 5.6 ) Hematological Reactions (including leukopenia, pancytopenia and thrombocytopenia) :...
The most serious adverse reactions were: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Heart Failure [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.5) ] Neurologic Reactions [see Warnings and Precautions (5.6) ] Hematologic Reactions [see Warnings and Precautions (5.7) ] Autoimmunity [see Warnings and Precautions (5.9) ] Immunosuppression [see Warnings and Precautions (5.11) ] Most common adverse reactions (≥7%): upper respiratory tract infection, rash, and urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice. In premarketing controlled trials of all adult p...
Source: FDA SPL label for Cimzia (UCB, Inc.), effective 20260224. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 13,287 | 11,680 | 11,193 | 11,786 | 10,485 | 12,713 | 12,091 | 3,462 |
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 05/2026 | Class II | UCB Biosciences Inc. | Lack of Assurance of Sterility |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $827,267 in payments to US physicians and hospitals tied to this drug across 21,937 transactions (Cimzia $827,267).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Cimzia (2 Pack) | 38,220 | $6,907 |
| Cimzia | 1,162 | $16,841 |
1 drug in the same class grades a letter or more higher than certolizumab pegol on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.