What the label lists and what reports show
Certolizumab side effects
Certolizumab's FDA label: “Most common adverse reactions (≥7%): upper respiratory tract infection, rash, and urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc.” FAERS holds 116,513 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (15,934 reports).
- No generic listed
- Boxed warning
Check it at the source: the certolizumab FDA label on DailyMed (effective February 24, 2026, UCB, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CIMZIA?CIMZIA can cause serious side effects, including: See " What is the most important information I should know about CIMZIA?" Heart failure including new heart failure or worsening of heart failure you already have. Symptoms include shortness of breath, swelling of your ankles or feet, or sudden weight gain. Allergic reactions. Get medical help right away if you have any signs of an allergic reaction which include a skin rash, swelling or itching of the face, tongue, lips, or throat, or trouble breathing. The plastic needle shield inside the removable cap of the prefilled syringe contains natural rubber and may cause an allergic reaction if you are sensitive to latex. Hepatitis B virus reactivation in people who carry the virus in their blood. In some cases, people who received CIMZIA have died because of the hepatitis B virus being reactivated. […]
Source: FDA drug label, BLA125160 (Ucb Inc), as published by UCB, Inc., effective February 24, 2026 (SPL set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥7%): upper respiratory tract infection, rash, and urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc.
Table 1: Adverse Reactions Reported by ≥3% of Patients Treated with CIMZIA Dosed Every Other Week during Placebo-Controlled Period of Rheumatoid Arthritis Studies, with Concomitant Methotrexate.
| Adverse Reaction (Preferred Term) | Placebo+ MTX EOW = Every other Week, MTX = Methotrexate. (%) N =324 | CIMZIA 200 mg EOW + MTX(%) N =640 |
|---|---|---|
| Upper respiratory tract infection | 2 | 6 |
| Headache | 4 | 5 |
| Hypertension | 2 | 5 |
| Nasopharyngitis | 1 | 5 |
| Back pain | 1 | 4 |
| Pyrexia | 2 | 3 |
| Pharyngitis | 1 | 3 |
| Rash | 1 | 3 |
| Acute bronchitis | 1 | 3 |
| Fatigue | 2 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 patient populations combined the most common adverse reactions (≥ 8%) were upper respiratory infections (18%), rash (9%) and urinary tract infections (8%).
Source: FDA drug label, BLA125160 (Ucb Inc), as published by UCB, Inc., effective February 24, 2026 (SPL set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d), via openFDA; the full label on DailyMed
What do FAERS reports show?
116,513 reports list certolizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,589 are coded as a death and 21,465 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Certolizumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions