Drugs › Interleukin-2 receptor blocking antibody
Generic name
Basiliximab: adverse event reports filed with FDA
6,800 reports list it as a suspect or interacting product, 2004–2026. Class: Interleukin-2 receptor blocking antibody.
- 6,800
- reports as suspect product
- 0% of all reports · about 305 a year
- 600
- reports, 12 months to June 2026
- 803 in the 12 months before
- 98.1%
- marked serious by the reporter
- 98% across the class
- 23.6%
- record death among outcomes, as reported
- 1,605 reports · not verified by FDA
6,800 adverse event reports received by FDA list basiliximab, a generic name as a suspect or interacting product, from March 2004 to June 2026. A further 2,679 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 600 reports listed it, down 25% from 803 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 305 reports a year and 0% of the 20,646,523 reports in the database, and 80% of the reports for the interleukin-2 receptor blocking antibody class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (9.3%), off label use (9.2%) and cytomegalovirus infection (9.1%). A report can list several reactions, so shares add to more than 100%; 1,369 different terms appear across these reports. Drug ineffective is recorded in 9.3% of these reports, a larger share than in the median interleukin-2 receptor blocking antibody drug (5.6%).
98.1% of the reports are marked serious by the reporter (98% across the class); 23.6% record death among the outcomes and 39.2% record hospitalisation, as reported. 64.8% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (33.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Basiliximab reports recording the termmedian drug in interleukin-2 receptor blocking antibody
- Drug ineffectivethe medicine did not work as expected9.3%631
- Off label useused for a purpose or in a way not on the label9.2%627
- Cytomegalovirus infection9.1%622
- Transplant rejection7.8%527
- Product use in unapproved indicationused for a purpose not on the label5.6%382
- Multiple organ dysfunction syndromeseveral organs failing5.1%344
- Pyrexiafever4.9%333
- Kidney transplant rejection4.9%331
- Polyomavirus-associated nephropathy4.6%313
- Acute kidney injurysudden loss of kidney function4.5%308
- Diarrhoealoose or frequent stools4.4%296
- Pneumonialung infection4%270
- Renal impairmentreduced kidney function4%269
- Sepsisa severe body-wide response to infection4%269
- Leukopenialow white blood cells3.8%258
- Anaemialow red blood cells3.7%254
- Urinary tract infectionbladder or urinary infection3.5%235
- BK virus infection3.3%224
- Neutropenialow neutrophils, a type of white blood cell3.3%223
- Respiratory failurethe lungs could not supply enough oxygen3.1%210
- Blood creatinine increasedraised creatinine, a kidney test3%207
- Cytomegalovirus viraemia3%201
- Post transplant lymphoproliferative disorder2.9%199
- Aspergillus infection2.9%197
- Thrombotic microangiopathy2.8%193
- Pancytopenialow counts of all blood cells2.6%178
- Septic shockshock arising from infection2.5%170
- Thrombocytopenialow platelets2.5%168
- Toxicity to various agentspoisoning or toxic effect of one or more substances2.4%166
- Complications of transplanted kidney2.4%163
Top 30 of 1,369 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the interleukin-2 receptor blocking antibody class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,496 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 23.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Immunosuppressant drug therapy | 2,643 | 38.9% |
| Immunosuppression | 937 | 13.8% |
| Renal transplant | 868 | 12.8% |
| Prophylaxis against transplant rejection | 808 | 11.9% |
| Liver transplant | 196 | 2.9% |
| Graft versus host disease | 79 | 1.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,800 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Basiliximab reports |
|---|---|---|
| Tacrolimus | 5,314 | 78.1% |
| Mycophenolate mofetil | 4,514 | 66.4% |
| Methylprednisolone | 2,532 | 37.2% |
| Prednisone | 2,160 | 31.8% |
| Prednisolone | 1,738 | 25.6% |
| Cyclosporine | 883 | 13% |
| Valganciclovir | 865 | 12.7% |
| Rituximab | 722 | 10.6% |
| Mycophenolic acid | 645 | 9.5% |
| Ganciclovir | 494 | 7.3% |
Other products listed in reports where Basiliximab is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Basiliximab | Interleukin-2 receptor blocking antibody | All reports |
|---|---|---|---|
| Reports as suspect product | 6,800 | 8,496 | 20,646,523 |
| Share of that pool | — | 80% | 0% |
| Reports, latest 12 months | 600 | — | 1,332,454 |
| Marked serious | 98.1% | 98% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 236 | 228 | 91 |
| Hospitalisation recorded, per 1,000 reports | 392 | 423 | 213 |
| Consumer-filed share | 3.1% | 5.5% | 45.8% |
| Top term, share of reports | Drug ineffective 9.3% | median 5.6% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the interleukin-2 receptor blocking antibody class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Simulect | brand | 1,696 | 38 | 97.6% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Basiliximab reports
How many adverse event reports has FDA received for Basiliximab?
6,800 reports list Basiliximab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 600 of them arrived in the latest 12 months. Another 2,679 list it only as a concomitant medication.
What reactions are recorded in Basiliximab reports?
drug ineffective (9.3%), off label use (9.2%), cytomegalovirus infection (9.1%), transplant rejection (7.8%) and product use in unapproved indication (5.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Basiliximab was responsible.
How serious are the reports?
98.1% are marked serious by the reporter. Among the outcomes recorded, 23.6% of reports include death and 39.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (64.8%), physician (30.2%) and consumer or non-health professional (3.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Basiliximab rising?
600 reports in the 12 months to June 2026, down 25% from 803 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Basiliximab was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Basiliximab?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Basiliximab as a suspect or interacting product; reports listing it only as a concomitant medication (2,679) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.