What the label lists and what reports show
Golimumab side effects
Golimumab's FDA label: “Most common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ).” FAERS holds 12,308 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 (2,899 reports).
- No generic listed
- Boxed warning
Check it at the source: the golimumab FDA label on DailyMed (effective September 9, 2025, Janssen Biotech, 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 SIMPONI ARIA?SIMPONI ARIA can cause serious side effects, including: See " What is the most important information I should know about SIMPONI ARIA? " Serious Infections. Some patients have an increased chance of getting serious infections while receiving SIMPONI ARIA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with SIMPONI ARIA your doctor will treat your infection and may need to stop your SIMPONI ARIA treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving SIMPONI ARIA: a fever feel very tired have a cough have flu-like symptoms warm, red, or painful skin Your doctor will examine you for TB and perform a test to see if you have TB. […]
Source: FDA drug label, Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ).
Table 1: Adverse Drug Reactions Reported by ≥ 1% of SIMPONI ARIA-Treated Patients and with a Higher Incidence than Placebo-Treated Patients in Trial RA through Week 24
| Reaction | Placebo + MTX | SIMPONI ARIA + MTX |
|---|---|---|
| Patients treated | 197 | 463 |
| Upper respiratory tract infection (such as upper respiratory tract infection,… | 12% | 13% |
| Viral infections (such as influenza and herpes) | 3% | 4% |
| Bacterial infections | 0% | 1% |
| Bronchitis | 1% | 3% |
| Hypertension | 2% | 3% |
| Rash | 1% | 3% |
| Pyrexia | 1% | 2% |
| Leukopenia | 0% | 1% |
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) ] Most common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described below are based on one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by intravenous infusion (Trial RA). The protocol included provisions for patients taking placebo to receive treatment with SIMPONI ARIA at Week 16 or Week 24 either by patient response (based on uncontrolled disease activity) or by design, so that adverse events cannot always be unambiguously attributed to a given treatment. …
Source: FDA drug label, Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,308 reports list golimumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,587 are coded as a death and 4,284 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, 4 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?
- Golimumab: 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