Simulect (basiliximab) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Simulect
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Basiliximab
Class: Interleukin-2 receptor blocking antibody

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 1,696 adverse event reports that name Simulect. In these reports the drug is a suspect or interacting product.

In the same period, 622 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 38 reports in the 12 months to June 2026 and 66 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 38 (under 0.1%) name Simulect. Reports from consumers or other non-health professionals were 15.1% of the reports that name Simulect and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Simulect is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 4 reports that name Simulect.
In January to March 2026, FDA received 4.
In April to June 2025, FDA received 11.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 261 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 1,696 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 261 terms.

Reaction terms in the reports that name Simulect, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,696 reports
Kidney transplant rejection	323	19%
Blood creatinine increasedraised creatinine, a kidney test	208	12.3%
Pyrexiafever	172	10.1%
Transplant rejection	147	8.7%
Cytomegalovirus infection	140	8.3%
Diarrhoealoose or frequent stools	104	6.1%
Complications of transplanted kidney	82	4.8%
Renal impairmentreduced kidney function	82	4.8%
Anaemialow red blood cells	79	4.7%
Sepsisa severe body-wide response to infection	68	4%
Hypotensionlow blood pressure	67	4%
Renal tubular necrosis	65	3.8%
Abdominal painstomach or belly pain	64	3.8%
Urine output decreased	63	3.7%
Respiratory failurethe lungs could not supply enough oxygen	62	3.7%
Urinary tract infectionbladder or urinary infection	61	3.6%
Haemoglobin decreasedlow haemoglobin	57	3.4%
Neutropenialow neutrophils, a type of white blood cell	57	3.4%
Off label useused for a purpose or in a way not on the label	55	3.2%
Product use in unapproved indicationused for a purpose not on the label	50	2.9%
Vomitingbeing sick	48	2.8%
Thrombotic microangiopathy	47	2.8%
Hypertensionhigh blood pressure	46	2.7%
Cytomegalovirus viraemia	42	2.5%
Dyspnoeashortness of breath	41	2.4%
Multi-organ failure	41	2.4%
Tubulointerstitial nephritis	41	2.4%
Delayed graft function	40	2.4%
Anuria	39	2.3%
Nephropathy toxic	39	2.3%
Pneumonialung infection	39	2.3%
Cardiac arrestthe heart stopped	36	2.1%
Renal tubular injury	35	2.1%
Malaisegeneral feeling of being unwell	34	2%
Drug ineffectivethe medicine did not work as expected	33	1.9%
Platelet count decreasedlow platelet count	33	1.9%
Renal failurekidney failure	33	1.9%
Cardiac failureheart failure	32	1.9%
Nauseafeeling sick	32	1.9%
Polyomavirus-associated nephropathy	31	1.8%
Leukopenialow white blood cells	30	1.8%
Pleural effusionfluid around the lung	30	1.8%
Glomerulonephritis	29	1.7%
Immunosuppressant drug level increased	29	1.7%
Blood urea increased	28	1.7%
C-reactive protein increased	28	1.7%
Pneumocystis jirovecii pneumonia	28	1.7%
Acute respiratory distress syndrome	26	1.5%
Inflammation	26	1.5%
Thrombocytopenialow platelets	26	1.5%

Download all 261 terms of Simulect (CSV)

The counts add to more than 1,696 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Basiliximab with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Basiliximab	Generic name	6,800
Simulect (this page)	Brand name	1,696

Sum of the separately reported names: 8,496. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Simulect, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	42	40	17	6	20	7	0	10	2
2005	39	39	8	4	21	1	0	15	0
2006	44	44	4	3	36	0	1	15	0
2007	40	40	12	3	21	1	0	17	0
2008	72	72	19	9	38	1	0	42	0
2009	67	67	17	8	37	2	0	36	0
2010	89	89	23	7	56	3	0	39	0
2011	101	101	23	5	48	6	0	56	0
2012	72	72	16	6	38	1	0	39	0
2013	99	99	24	6	60	0	0	55	0
2014	83	81	19	2	43	2	0	52	2
2015	86	85	14	15	55	3	0	52	1
2016	84	82	17	3	47	1	0	59	2
2017	51	50	13	3	21	0	0	32	1
2018	95	95	19	18	30	1	0	70	0
2019	107	104	10	14	52	1	0	77	3
2020	89	89	16	9	47	0	0	59	0
2021	56	54	12	11	23	2	0	37	2
2022	127	126	16	6	93	0	1	105	1
2023	63	61	10	6	27	0	0	47	2
2024	88	74	11	5	51	0	0	41	14
2025	86	75	8	12	55	0	0	57	11
2026	16	16	3	2	9	0	0	16	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Simulect, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Simulect, by the year in which FDA received them
Year	Reports
2004	33
2005	38
2006	49
2007	41
2008	74
2009	72
2010	86
2011	115
2012	92
2013	105
2014	90
2015	82
2016	75
2017	56
2018	121
2019	94
2020	76
2021	51
2022	110
2023	88
2024	90
2025	50
2026	8

Reports that name Simulect, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Simulect
Age	Reports	Share
Under 2	20	1.2%
2 to 11	52	3.1%
12 to 17	54	3.2%
18 to 44	437	25.8%
45 to 64	530	31.3%
65 to 74	111	6.5%
75 and over	4	0.2%
Age not given	488	28.8%

Sex of the patient in the reports that name Simulect
Sex	Reports	Share
Female	537	31.7%
Male	975	57.5%
Unknown or not given	184	10.8%

Type of reporter in the reports that name Simulect
Reporter	Reports	Share
Physician	655	38.6%
Pharmacist	73	4.3%
Other health professional	634	37.4%
Lawyer	1	0.1%
Consumer or non-health professional	256	15.1%
Not given	77	4.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 11.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Simulect record
Indication as recorded (MedDRA)	Reports	Share
Renal transplant	748	44.1%
Liver transplant	123	7.3%
Immunosuppression	120	7.1%
Immunosuppressant drug therapy	90	5.3%
Prophylaxis against transplant rejection	85	5%
Prophylaxis	21	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,696 reports.

Pages near this one

Basiliximab same ingredient
Simponi Aria next in the A to Z list
Simvastatin next in the A to Z list
Simponi next in the A to Z list
Simvastatine next in the A to Z list
Simlandi next in the A to Z list
Sinemet next in the A to Z list
Simethicone next in the A to Z list
Singulair next in the A to Z list
Simeprevir next in the A to Z list
Sintilimab next in the A to Z list
Simcor next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for SimulectThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Simulect: adverse event reports that FDA received. https://reportedreactions.com/drug/simulect/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Simulect as a suspect or interacting product. The 622 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Simulect was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Simulect?

No. It is a count of what people reported to FDA: 1,696 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (38.6%), other health professional (37.4%) and consumer or non-health professional (15.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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