Imbruvica (ibrutinib) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Ibrutinib
Class: Kinase inhibitor

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.

Reports on file

From December 2013 to June 2026, FDA received 67,039 adverse event reports that name Imbruvica. In these reports the drug is a suspect or interacting product.

In the same period, 1,078 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 2,283 reports in the 12 months to June 2026 and 3,172 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Imbruvica 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 522 reports that name Imbruvica.
In January to March 2026, FDA received 576.
In April to June 2025, FDA received 633.

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 1,812 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 67,035 of the 67,039 reports (99.9%).

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 1,812 terms.

Reaction terms in the reports that name Imbruvica, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 67,039 reports
Deaththe patient died; cause not stated by this term	7,941	11.8%
Off label useused for a purpose or in a way not on the label	4,856	7.2%
Fatiguetiredness	4,248	6.3%
Diarrhoealoose or frequent stools	3,550	5.3%
Atrial fibrillationan irregular heart rhythm	2,911	4.3%
Incorrect dose administeredthe wrong dose was given	2,666	4%
Contusiona bruise	2,625	3.9%
Pneumonialung infection	2,542	3.8%
Falla fall	2,332	3.5%
Astheniaweakness or lack of energy	2,136	3.2%
Nauseafeeling sick	1,993	3%
Arthralgiajoint pain	1,986	3%
Rashskin rash	1,894	2.8%
Muscle spasmsmuscle cramps	1,654	2.5%
Dizzinesslight-headedness or unsteadiness	1,561	2.3%
Hospitalisationadmission to hospital	1,560	2.3%
Painpain, site not specified	1,509	2.3%
Peripheral swellingswelling of the arms or legs	1,462	2.2%
Haemorrhagebleeding	1,437	2.1%
Covid-19COVID-19 infection	1,383	2.1%
Dyspnoeashortness of breath	1,358	2%
Platelet count decreasedlow platelet count	1,356	2%
White blood cell count increased	1,347	2%
Headachehead pain	1,319	2%
Pyrexiafever	1,315	2%
Disease progressionthe disease advanced	1,302	1.9%
Surgeryan operation	1,239	1.8%
Hypertensionhigh blood pressure	1,222	1.8%
Urinary tract infectionbladder or urinary infection	1,196	1.8%
Weight decreasedweight loss	1,139	1.7%
Pain in extremitypain in an arm or leg	1,110	1.7%
Haemoglobin decreasedlow haemoglobin	1,085	1.6%
Malaisegeneral feeling of being unwell	1,076	1.6%
White blood cell count decreasedlow white cell count	1,060	1.6%
Anaemialow red blood cells	1,035	1.5%
Pleural effusionfluid around the lung	1,019	1.5%
Cough	1,006	1.5%
Decreased appetitereduced appetite	992	1.5%
Myalgiamuscle pain	987	1.5%
Vomitingbeing sick	940	1.4%
Drug ineffectivethe medicine did not work as expected	930	1.4%
Constipation	927	1.4%
Infectionan infection, type not specified	911	1.4%
Epistaxisnosebleed	903	1.3%
Cataractclouding of the eye lens	890	1.3%
Back pain	878	1.3%
Lymphadenopathyswollen lymph nodes	835	1.2%
Nasopharyngitisa cold	826	1.2%
Cardiac disorder	825	1.2%
Stomatitissore mouth	798	1.2%

Download all 1,812 terms of Imbruvica (CSV)

The counts add to more than 67,039 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 Ibrutinib with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ibrutinib	Generic name	10,657
Imbruvica (this page)	Brand name	67,039

Sum of the separately reported names: 77,696. 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 Imbruvica, 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
2013	4	4	0	0	1	0	0	3	0
2014	733	666	224	9	419	5	0	196	67
2015	3,004	1,702	387	44	1,094	8	0	619	1,302
2016	3,408	2,515	388	70	1,369	21	0	1,329	893
2017	4,292	3,087	541	65	1,598	40	0	1,584	1,205
2018	5,826	3,551	608	61	1,794	18	0	1,883	2,275
2019	7,265	5,263	835	111	2,421	37	1	3,614	2,002
2020	8,959	7,678	1,980	100	2,796	47	0	4,186	1,281
2021	6,771	6,093	1,735	90	2,248	30	0	2,978	678
2022	10,824	5,949	1,487	58	2,211	20	0	3,074	4,875
2023	7,722	5,568	1,399	74	1,998	31	0	3,055	2,154
2024	4,067	3,767	787	62	1,239	20	1	2,354	300
2025	2,722	2,618	462	58	884	14	0	1,637	104
2026	1,442	1,398	278	43	527	7	1	817	44

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 Imbruvica, 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 Imbruvica, by the year in which FDA received them
Year	Reports
2013	4
2014	821
2015	3,569
2016	3,536
2017	4,304
2018	5,686
2019	7,230
2020	9,076
2021	6,436
2022	11,903
2023	7,089
2024	3,615
2025	2,672
2026	1,098

Reports that name Imbruvica, 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 Imbruvica
Age	Reports	Share
Under 2	7	under 0.1%
2 to 11	25	under 0.1%
12 to 17	36	0.1%
18 to 44	443	0.7%
45 to 64	6,219	9.3%
65 to 74	9,777	14.6%
75 and over	13,481	20.1%
Age not given	37,051	55.3%

Sex of the patient in the reports that name Imbruvica
Sex	Reports	Share
Female	24,781	37%
Male	37,948	56.6%
Unknown or not given	4,310	6.4%

Type of reporter in the reports that name Imbruvica
Reporter	Reports	Share
Physician	8,996	13.4%
Pharmacist	1,611	2.4%
Other health professional	8,864	13.2%
Lawyer	7	under 0.1%
Consumer or non-health professional	47,498	70.9%
Not given	63	0.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 79.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Imbruvica record
Indication as recorded (MedDRA)	Reports	Share
Chronic lymphocytic leukaemia	31,225	46.6%
Mantle cell lymphoma	4,686	7%
Waldenstrom's macroglobulinaemia	4,516	6.7%
B-cell small lymphocytic lymphoma	1,611	2.4%
Non-hodgkin's lymphoma	1,269	1.9%
Lymphocytic leukaemia	900	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 67,039 reports.

Drugs in the same reports

Other drugs that the reports of Imbruvica name, in any role, in order of name
Drug	Reports that name the two
Acyclovir	1,738
Allopurinol	3,740
Aspirin	3,414
Ergocalciferol	1,730
Levothyroxine	1,545
Lisinopril	2,126
Metoprolol	1,626
Omeprazole	1,957
Prednisone	1,951
Vitamin d	1,568

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

Ibrutinib same ingredient
Imatinib mesylate same class
Inlyta same class
Imatinib same class
Iressa same class
Idelalisib same class
Itovebi same class
Imcivree next in the A to Z list
Imatinib mesilate next in the A to Z list
Imdelltra (Amg757) next in the A to Z list
Imatinib Mes Tab 400mg next in the A to Z list
Imdevimab 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 ImbruvicaThe 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. Imbruvica: adverse event reports that FDA received. https://reportedreactions.com/drug/imbruvica/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Imbruvica as a suspect or interacting product. The 1,078 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 Imbruvica 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 Imbruvica?

No. It is a count of what people reported to FDA: 67,039 reports from December 2013 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 (70.9%), physician (13.4%) and other health professional (13.2%). 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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