Mabthera adverse event reports that FDA received

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

Name type: Product name as reported

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 21,200 adverse event reports that name Mabthera. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,113 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 453 reports in the 12 months to June 2026 and 1,875 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, 453 (under 0.1%) name Mabthera. Reports from physicians were 51% of the reports that name Mabthera and 21.9% 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 Mabthera 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 118 reports that name Mabthera.
In January to March 2026, FDA received 103.
In April to June 2025, FDA received 85.

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 1,125 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 21,200 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 1,125 terms.

Reaction terms in the reports that name Mabthera, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 21,200 reports
Off label useused for a purpose or in a way not on the label	2,311	10.9%
Pyrexiafever	1,322	6.2%
Deaththe patient died; cause not stated by this term	937	4.4%
Dyspnoeashortness of breath	864	4.1%
Pneumonialung infection	765	3.6%
Neutropenialow neutrophils, a type of white blood cell	744	3.5%
Disease progressionthe disease advanced	718	3.4%
Chillschills or shivering	626	3%
Drug ineffectivethe medicine did not work as expected	555	2.6%
Nauseafeeling sick	548	2.6%
Progressive multifocal leukoencephalopathyPML, a rare brain infection	537	2.5%
No adverse eventno adverse event was reported	524	2.5%
Febrile neutropeniafever with low white blood cells	513	2.4%
Leukopenialow white blood cells	501	2.4%
Thrombocytopenialow platelets	486	2.3%
Pruritusitching	480	2.3%
Diarrhoealoose or frequent stools	465	2.2%
Vomitingbeing sick	460	2.2%
Infectionan infection, type not specified	458	2.2%
Agranulocytosis	453	2.1%
Rashskin rash	448	2.1%
Anaemialow red blood cells	428	2%
Intentional product use issuedeliberate use not as intended	428	2%
Astheniaweakness or lack of energy	423	2%
Arthralgiajoint pain	411	1.9%
Painpain, site not specified	410	1.9%
Hypotensionlow blood pressure	379	1.8%
Malaisegeneral feeling of being unwell	376	1.8%
Headachehead pain	373	1.8%
Myelosuppression	365	1.7%
Fatiguetiredness	357	1.7%
Hypersensitivityan allergic-type reaction	346	1.6%
Sepsisa severe body-wide response to infection	342	1.6%
Bone marrow failure	340	1.6%
Pancytopenialow counts of all blood cells	330	1.6%
Cough	312	1.5%
Hypertensionhigh blood pressure	308	1.5%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	299	1.4%
Urinary tract infectionbladder or urinary infection	285	1.3%
White blood cell count decreasedlow white cell count	285	1.3%
Platelet count decreasedlow platelet count	276	1.3%
Weight decreasedweight loss	276	1.3%
Interstitial lung diseasescarring or inflammation of lung tissue	270	1.3%
Pain in extremitypain in an arm or leg	268	1.3%
Dizzinesslight-headedness or unsteadiness	258	1.2%
Erythemaskin redness	258	1.2%
Infusion related reactiona reaction during or soon after an infusion	250	1.2%
Respiratory failurethe lungs could not supply enough oxygen	245	1.2%
Renal failurekidney failure	224	1.1%
Product use in unapproved indicationused for a purpose not on the label	223	1.1%

Download all 1,125 terms of Mabthera (CSV)

The counts add to more than 21,200 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.

Outcomes by year

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

Outcomes in the reports that name Mabthera, 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	55	54	22	8	22	1	0	16	1
2005	64	64	10	6	38	2	0	22	0
2006	109	106	33	17	53	3	0	31	3
2007	265	265	63	37	139	13	0	85	0
2008	785	785	212	67	315	37	0	352	0
2009	889	882	209	97	380	16	0	384	7
2010	893	892	234	80	405	36	0	307	1
2011	909	907	202	70	457	29	0	370	2
2012	1,730	1,728	361	108	875	48	1	793	2
2013	1,227	1,223	290	97	564	52	1	575	4
2014	1,167	1,163	241	102	524	54	3	587	4
2015	1,112	1,100	186	94	556	54	1	560	12
2016	1,186	1,175	191	74	557	58	1	614	11
2017	1,281	1,110	193	77	543	41	2	552	171
2018	1,476	1,469	177	88	729	63	4	800	7
2019	1,418	1,411	168	83	539	25	1	878	7
2020	1,193	1,188	172	83	364	48	0	806	5
2021	712	707	101	47	264	20	0	442	5
2022	882	872	91	47	327	8	0	600	10
2023	968	962	150	82	327	8	4	624	6
2024	2,059	573	108	44	244	12	1	323	1,486
2025	503	492	83	31	171	12	4	303	11
2026	317	306	40	17	98	9	3	228	11

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 Mabthera, 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 Mabthera, by the year in which FDA received them
Year	Reports
2004	35
2005	60
2006	94
2007	241
2008	747
2009	871
2010	975
2011	921
2012	2,023
2013	1,303
2014	1,126
2015	1,140
2016	1,157
2017	1,271
2018	1,446
2019	1,422
2020	1,137
2021	703
2022	920
2023	947
2024	2,015
2025	425
2026	221

Reports that name Mabthera, 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 Mabthera
Age	Reports	Share
Under 2	38	0.2%
2 to 11	210	1%
12 to 17	195	0.9%
18 to 44	2,125	10%
45 to 64	5,035	23.8%
65 to 74	3,393	16%
75 and over	2,158	10.2%
Age not given	8,046	38%

Sex of the patient in the reports that name Mabthera
Sex	Reports	Share
Female	10,547	49.8%
Male	8,629	40.7%
Unknown or not given	2,024	9.5%

Type of reporter in the reports that name Mabthera
Reporter	Reports	Share
Physician	10,807	51%
Pharmacist	1,096	5.2%
Other health professional	4,870	23%
Lawyer	41	0.2%
Consumer or non-health professional	3,944	18.6%
Not given	442	2.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 2.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mabthera record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	3,819	18%
Diffuse large b-cell lymphoma	2,498	11.8%
B-cell lymphoma	1,565	7.4%
Non-hodgkin's lymphoma	1,330	6.3%
Chronic lymphocytic leukaemia	1,132	5.3%
Lymphoma	816	3.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 21,200 reports.

Drugs in the same reports

Other drugs that the reports of Mabthera name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	4,705
Cytarabine	1,121
Dexamethasone	1,286
Doxorubicin	1,848
Doxorubicin hydrochloride	1,374
Etoposide	1,170
Methotrexate	2,559
Prednisolone	1,838
Prednisone	3,081
Vincristine	3,006

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for MabtheraThe 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.

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Reported Reactions. Mabthera: adverse event reports that FDA received. https://reportedreactions.com/drug/mabthera/ 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 Mabthera as a suspect or interacting product. The 1,113 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 Mabthera 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 Mabthera?

No. It is a count of what people reported to FDA: 21,200 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 (51%), other health professional (23%) and consumer or non-health professional (18.6%). 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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