Belimumab adverse event reports that FDA received

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

Name type: Generic name
Class: B lymphocyte stimulator-specific inhibitor
Also reported as: Belimumab Solution For Injection

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 November 2011 to June 2026, FDA received 4,254 adverse event reports that name Belimumab. In these reports the drug is a suspect or interacting product.

In the same period, 329 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 654 reports in the 12 months to June 2026 and 669 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, 654 (under 0.1%) name Belimumab. Reports for male patients were 7.2% of the reports that name Belimumab and 34.6% 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 Belimumab 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 125 reports that name Belimumab.
In January to March 2026, FDA received 214.
In April to June 2025, FDA received 127.

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 479 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 4,231 of the 4,254 reports (99.5%).

The reports of the other years are not in the counts.

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 479 terms.

Reaction terms in the reports that name Belimumab, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,254 reports
Systemic lupus erythematosuslupus, an autoimmune disease	1,160	27.3%
Product dose omission issuea dose was missed	545	12.8%
Drug ineffectivethe medicine did not work as expected	421	9.9%
Painpain, site not specified	261	6.1%
Fatiguetiredness	256	6%
Off label useused for a purpose or in a way not on the label	256	6%
Inappropriate schedule of product administrationthe product was taken at the wrong times	255	6%
Condition aggravatedthe condition being treated got worse	226	5.3%
Arthralgiajoint pain	224	5.3%
Lupus nephritis	218	5.1%
Malaisegeneral feeling of being unwell	187	4.4%
Headachehead pain	183	4.3%
Pyrexiafever	176	4.1%
Nauseafeeling sick	172	4%
Urinary tract infectionbladder or urinary infection	152	3.6%
Pneumonialung infection	145	3.4%
Rashskin rash	128	3%
Exposure during pregnancythe medicine was taken during pregnancy	121	2.8%
Covid-19COVID-19 infection	118	2.8%
Influenzaflu	115	2.7%
Illness	112	2.6%
Deaththe patient died; cause not stated by this term	105	2.5%
Nasopharyngitisa cold	104	2.4%
Cough	100	2.4%
Diarrhoealoose or frequent stools	97	2.3%
Astheniaweakness or lack of energy	95	2.2%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	95	2.2%
Hospitalisationadmission to hospital	94	2.2%
Herpes zostershingles	89	2.1%
Pain in extremitypain in an arm or leg	88	2.1%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	87	2%
Dyspnoeashortness of breath	86	2%
Dizzinesslight-headedness or unsteadiness	84	2%
Treatment failurethe treatment did not work	84	2%
Arthritis	82	1.9%
Product use issuea problem in how the product was used	78	1.8%
Infectionan infection, type not specified	76	1.8%
Vomitingbeing sick	76	1.8%
SLE arthritis	75	1.8%
Proteinuriaprotein in the urine	74	1.7%
Alopeciahair loss	72	1.7%
Weight decreasedweight loss	72	1.7%
Peripheral swellingswelling of the arms or legs	70	1.6%
Product use in unapproved indicationused for a purpose not on the label	70	1.6%
Pruritusitching	70	1.6%
Erythemaskin redness	65	1.5%
Joint swellinga swollen joint	64	1.5%
Falla fall	63	1.5%
Myalgiamuscle pain	57	1.3%
Injection site painpain where the injection was given	56	1.3%

Download all 479 terms of Belimumab (CSV)

The counts add to more than 4,254 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 Belimumab with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Belimumab (this page)	Generic name	4,254
Benlysta	Brand name	26,021

Sum of the separately reported names: 30,275. 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 Belimumab, 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
2011	4	4	0	2	4	0	0	1	0
2012	18	17	3	1	12	1	0	10	1
2013	19	19	0	3	15	1	0	4	0
2014	51	38	2	3	32	1	0	17	13
2015	214	167	4	8	68	2	2	135	47
2016	100	97	2	5	43	1	3	79	3
2017	109	109	7	6	50	2	4	101	0
2018	237	235	17	7	74	3	3	210	2
2019	332	324	16	8	83	3	4	301	8
2020	191	180	16	7	55	2	2	161	11
2021	193	182	22	3	53	1	1	164	11
2022	389	371	49	20	146	1	3	312	18
2023	370	328	27	9	90	2	14	280	42
2024	827	702	37	27	205	8	0	611	125
2025	816	734	32	16	236	11	3	657	82
2026	384	349	7	0	94	4	5	304	35

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 Belimumab, 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 Belimumab, by the year in which FDA received them
Year	Reports
2011	3
2012	23
2013	33
2014	100
2015	232
2016	115
2017	142
2018	222
2019	387
2020	223
2021	244
2022	340
2023	423
2024	840
2025	588
2026	339

Reports that name Belimumab, 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 Belimumab
Age	Reports	Share
Under 2	25	0.6%
2 to 11	8	0.2%
12 to 17	59	1.4%
18 to 44	1,057	24.8%
45 to 64	761	17.9%
65 to 74	147	3.5%
75 and over	29	0.7%
Age not given	2,168	51%

Sex of the patient in the reports that name Belimumab
Sex	Reports	Share
Female	2,355	55.4%
Male	305	7.2%
Unknown or not given	1,594	37.5%

Type of reporter in the reports that name Belimumab
Reporter	Reports	Share
Physician	1,534	36.1%
Pharmacist	121	2.8%
Other health professional	930	21.9%
Lawyer	0	0%
Consumer or non-health professional	1,658	39%
Not given	11	0.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 47.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Belimumab record
Indication as recorded (MedDRA)	Reports	Share
Systemic lupus erythematosus	2,994	70.4%
Lupus nephritis	220	5.2%
Chronic cutaneous lupus erythematosus	55	1.3%
Immunosuppression	25	0.6%
Immunosuppressant drug therapy	16	0.4%
Sjogren's syndrome	15	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,254 reports.

Drugs in the same reports

Other drugs that the reports of Belimumab name, in any role, in order of name
Drug	Reports that name the two
Azathioprine	455
Cyclophosphamide	254
Hydroxychloroquine	846
Methotrexate	456
Mycophenolate mofetil	597
Plaquenil	182
Prednisolone	452
Prednisone	683
Rituximab	304
Tacrolimus	174

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Benlysta same ingredient
Belbuca next in the A to Z list
Beloc Zok next in the A to Z list
Belatacept next in the A to Z list
Belsomra next in the A to Z list
Belantamab mafodotin next in the A to Z list
Belumosudil next in the A to Z list
Bedaquiline next in the A to Z list
Belumosudil mesylate next in the A to Z list
Beclomethasone dipropionate next in the A to Z list
Belviq next in the A to Z list
Beclomethasone 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 BelimumabThe 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. Belimumab: adverse event reports that FDA received. https://reportedreactions.com/drug/belimumab/ 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 Belimumab as a suspect or interacting product. The 329 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 Belimumab 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 Belimumab?

No. It is a count of what people reported to FDA: 4,254 reports from November 2011 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?

Consumer or non-health professional (39%), physician (36.1%) and other health professional (21.9%). 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.

To the top of the page