What the label lists and what reports show
Infliximab-dyyb side effects
Infliximab-dyyb's FDA label: “Most common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.” FAERS holds 29,059 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 arthralgia (4,932 reports).
- No generic listed
- Boxed warning
Check it at the source: the infliximab-dyyb FDA label on DailyMed (effective August 18, 2026, CELLTRION USA 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 ZYMFENTRA ?ZYMFENTRA can cause serious side effects, including (see " What is the most important information I should know about ZYMFENTRA ? "): Serious Infections Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as ZYMFENTRA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with ZYMFENTRA your doctor will treat your infection and may need to stop your ZYMFENTRA treatment. […]
Source: FDA drug label, CELLTRION USA Inc., effective August 18, 2026 (SPL set 93a193ab-9f96-4da6-aa7c-31212e81879a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.
Table 2 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind…
| Reaction | ZYMFENTRA 120 mg Subcutaneous Injection b N=222 (%) | Placebo N=101 (%) |
|---|---|---|
| COVID-19 | 10 | 5 |
| Headache | 8 | 4 |
| Upper respiratory track infectionsd c | 7 | 3 |
| Injection site reaction d | 5 | 1 |
| Diarrhea | 5 | 1 |
| Increased blood creatine phosphokinase | 4 | 2 |
| Arthralgia | 4 | 3 |
| Increased alaine aninotransferase | 4 | 1 |
| Hypertensions e | 3 | 2 |
| Urinary track infection f | 3 | 2 |
| Neutropenia | 3 | 0 |
| Dizziness | 3 | 0 |
| Leukopenia | 3 | 0 |
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 following clinically significant adverse reactions are described elsewhere in the labeling: Serious infections [ see Warnings and Precautions ( 5.1 ) ] Malignancies [ see Warnings and Precautions ( 5.2 ) ] Hepatitis B virus reactivation [ see Warnings and Precautions ( 5.3 ) ] Hepatotoxicity [ see Warning and Precautions ( 5.4 ) ] Congestive heart failure [ see Warnings and Precautions ( 5.5 ) ] Hematologic reactions [ see Warnings and Precautions ( 5.6 ) ] Hypersensitivity and other administration reactions [ see Warnings and Precautions ( 5.7 ) ] Neruologic reactions [ see Warnings and Precautions ( 5.8 ) ] Autoimmunity [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain. ( 6.1 ) Crohn's Disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, CELLTRION USA Inc., effective August 18, 2026 (SPL set 93a193ab-9f96-4da6-aa7c-31212e81879a), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,059 reports list infliximab-dyyb among the medicines taken, each a report of something that happened, not proof the medicine caused it; 703 are coded as a death and 7,127 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 19 reactions below, 10 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?
- Infliximab-dyyb: 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