What the label lists and what reports show
Belatacept side effects
Belatacept's FDA label: “Most common adverse reactions (≥20% on NULOJIX treatment) are anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, and leukopenia.” FAERS holds 4,651 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 transplant rejection (226 reports).
- No generic listed
- Boxed warning
Check it at the source: the belatacept FDA label on DailyMed (effective July 28, 2021, E.R. Squibb & Sons, L.L.C.); 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 NULOJIX?NULOJIX increases your risk of serious side effects that can cause death. See " What is the most important information I should know about NULOJIX? " Common side effects of NULOJIX include: • low red blood count (anemia) • diarrhea • kidney or bladder infection • swollen legs, feet, or ankles • constipation • high blood pressure • fever • new kidney not working well • cough • nausea or vomiting • headache • low potassium or high potassium in your blood • low white blood cell count Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of NULOJIX. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to BMS at 1-800-321-1335.
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective July 28, 2021 (SPL set c16ac648-d5d2-9f7d-8637-e2328572754e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20% on NULOJIX treatment) are anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, and leukopenia.
Table 4: Adverse Reactions Reported by ≥10% of Patients Treated with Either the NULOJIX Recommended Regimen or Control in Studies 1 and 2 Through Three Years a,b
| Adverse Reaction | NULOJIX Recommended Regimen N=401 % | Cyclosporine N=405 % |
|---|---|---|
| Urinary tract infection | 37 | 36 |
| Upper respiratory infection | 15 | 16 |
| Nasopharyngitis | 13 | 16 |
| Cytomegalovirus infection | 12 | 12 |
| Influenza | 11 | 8 |
| Bronchitis | 10 | 7 |
| Diarrhea | 39 | 36 |
| Constipation | 33 | 35 |
| Nausea | 24 | 27 |
| Vomiting | 22 | 20 |
| Abdominal pain | 19 | 16 |
| Abdominal pain upper | 9 | 10 |
| Hyperkalemia | 20 | 20 |
| Hypokalemia | 21 | 14 |
| Hypophosphatemia | 19 | 13 |
| Dyslipidemia | 19 | 24 |
| Hyperglycemia | 16 | 17 |
| Hypocalcemia | 13 | 11 |
| Hypercholesterolemia | 11 | 11 |
| Hypomagnesemia | 7 | 10 |
| Hyperuricemia | 5 | 12 |
| Graft dysfunction | 25 | 34 |
| Peripheral edema | 34 | 42 |
| Pyrexia | 28 | 26 |
| Anemia | 45 | 44 |
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 reported with NULOJIX are: • PTLD, predominantly CNS PTLD, and other malignancies [see Boxed Warning and Warnings and Precautions (5.1 , 5.3) ] • Serious infections, including JC virus-associated PML and polyoma virus nephropathy [see Warnings and Precautions (5.4 , 5.5 , 5.6) ] Most common adverse reactions (≥20% on NULOJIX treatment) are anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, and leukopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The data described below primarily derive from two randomized, active-controlled three-year trials of NULOJIX in de novo kidney transplant patients. In Study 1 and Study 2, NULOJIX was studied at the recommended dose and frequency [see Dosage and Administration (2.1) ] in a total of 401 patients compared to a cyclosporine control regimen in a total of 405 patients. …
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective July 28, 2021 (SPL set c16ac648-d5d2-9f7d-8637-e2328572754e), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,651 reports list belatacept among the medicines taken, each a report of something that happened, not proof the medicine caused it; 742 are coded as a death and 1,762 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, 8 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?
- Belatacept: 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