Eltrombopag adverse event reports that FDA received

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

Name type: Generic name
Class: Thrombopoietin receptor agonist
Also reported as: Eltrombopag Tablet

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 September 2008 to June 2026, FDA received 2,704 adverse event reports that name Eltrombopag. In these reports the drug is a suspect or interacting product.

In the same period, 1,013 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 359 reports in the 12 months to June 2026 and 242 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, 359 (under 0.1%) name Eltrombopag. Reports from consumers or other non-health professionals were 12.2% of the reports that name Eltrombopag 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 Eltrombopag 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 93 reports that name Eltrombopag.
In January to March 2026, FDA received 89.
In April to June 2025, FDA received 65.

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 259 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 2,693 of the 2,704 reports (99.6%).

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 259 terms.

Reaction terms in the reports that name Eltrombopag, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,704 reports
Drug ineffectivethe medicine did not work as expected	378	14%
Platelet count decreasedlow platelet count	317	11.7%
Off label useused for a purpose or in a way not on the label	257	9.5%
Product use in unapproved indicationused for a purpose not on the label	185	6.8%
Thrombocytopenialow platelets	167	6.2%
Therapy non-responderthe treatment did not work	147	5.4%
Pyrexiafever	98	3.6%
Deaththe patient died; cause not stated by this term	97	3.6%
Headachehead pain	91	3.4%
Pneumonialung infection	87	3.2%
Treatment failurethe treatment did not work	85	3.1%
Immune thrombocytopenia	81	3%
Sepsisa severe body-wide response to infection	81	3%
Pulmonary embolisma blood clot in the lung	78	2.9%
Anaemialow red blood cells	77	2.8%
Pancytopenialow counts of all blood cells	71	2.6%
Platelet count abnormal	71	2.6%
Haemorrhagebleeding	68	2.5%
Petechiaetiny bleeding spots in the skin	67	2.5%
Febrile neutropeniafever with low white blood cells	66	2.4%
Deep vein thrombosisa blood clot in a deep vein	64	2.4%
Acute kidney injurysudden loss of kidney function	61	2.3%
Gingival bleedingbleeding gums	60	2.2%
Infectionan infection, type not specified	59	2.2%
Drug ineffective for unapproved indication	57	2.1%
Epistaxisnosebleed	56	2.1%
Diarrhoealoose or frequent stools	54	2%
Platelet count increased	53	2%
Fatiguetiredness	52	1.9%
Haemoglobin decreasedlow haemoglobin	51	1.9%
Contusiona bruise	50	1.8%
Disease progressionthe disease advanced	49	1.8%
Myelofibrosis	48	1.8%
Dyspnoeashortness of breath	46	1.7%
Nauseafeeling sick	44	1.6%
Therapy partial responder	43	1.6%
Aplastic anaemia	42	1.6%
Astheniaweakness or lack of energy	40	1.5%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	39	1.4%
Vomitingbeing sick	38	1.4%
Therapeutic response decreasedthe medicine worked less well	37	1.4%
Abdominal painstomach or belly pain	36	1.3%
Drug intolerancethe medicine was not tolerated	36	1.3%
Acute myeloid leukaemia	35	1.3%
Acute myocardial infarction	35	1.3%
Disease recurrencethe disease came back	33	1.2%
Neutropenialow neutrophils, a type of white blood cell	33	1.2%
Thrombocytosis	33	1.2%
Thrombosis	33	1.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	32	1.2%

Download all 259 terms of Eltrombopag (CSV)

The counts add to more than 2,704 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 Eltrombopag, 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
2008	4	4	0	0	4	0	0	0	0
2009	54	54	5	3	40	2	0	12	0
2010	90	90	18	6	63	1	0	21	0
2011	35	35	7	5	17	1	0	13	0
2012	22	22	4	2	17	0	0	4	0
2013	58	58	9	4	31	2	0	20	0
2014	107	98	17	6	57	7	0	54	9
2015	244	197	61	20	105	4	0	137	47
2016	114	109	29	6	55	5	0	62	5
2017	101	100	32	9	43	2	0	58	1
2018	168	161	23	9	37	2	0	116	7
2019	201	182	24	13	53	0	1	128	19
2020	174	165	30	4	33	3	1	123	9
2021	212	205	29	14	66	1	0	161	7
2022	190	185	35	17	54	2	0	146	5
2023	157	152	37	15	67	0	0	104	5
2024	226	216	13	30	90	2	0	161	10
2025	326	316	51	31	98	3	2	243	10
2026	221	197	17	14	71	2	0	142	24

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 Eltrombopag, 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 Eltrombopag, by the year in which FDA received them
Year	Reports
2008	3
2009	55
2010	88
2011	37
2012	31
2013	80
2014	118
2015	231
2016	114
2017	107
2018	168
2019	215
2020	186
2021	220
2022	186
2023	165
2024	232
2025	286
2026	182

Reports that name Eltrombopag, 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 Eltrombopag
Age	Reports	Share
Under 2	16	0.6%
2 to 11	121	4.5%
12 to 17	93	3.4%
18 to 44	362	13.4%
45 to 64	540	20%
65 to 74	404	14.9%
75 and over	331	12.2%
Age not given	837	31%

Sex of the patient in the reports that name Eltrombopag
Sex	Reports	Share
Female	1,166	43.1%
Male	1,033	38.2%
Unknown or not given	505	18.7%

Type of reporter in the reports that name Eltrombopag
Reporter	Reports	Share
Physician	1,090	40.3%
Pharmacist	46	1.7%
Other health professional	1,170	43.3%
Lawyer	0	0%
Consumer or non-health professional	330	12.2%
Not given	68	2.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 21.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Eltrombopag record
Indication as recorded (MedDRA)	Reports	Share
Immune thrombocytopenia	563	20.8%
Thrombocytopenia	413	15.3%
Immune thrombocytopenic purpura	359	13.3%
Aplastic anaemia	345	12.8%
Myelodysplastic syndrome	134	5%
Idiopathic thrombocytopenic purpura	55	2%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,704 reports.

Drugs in the same reports

Other drugs that the reports of Eltrombopag name, in any role, in order of name
Drug	Reports that name the two
Azathioprine	119
Cyclosporine	398
Dexamethasone	221
Human immunoglobulin g	138
Methylprednisolone	154
Mycophenolate mofetil	211
Prednisolone	228
Prednisone	254
Rituximab	435
Romiplostim	242

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

Eltrombopag olamine same class
Nplate same class
Promacta same class
Elspar next in the A to Z list
Elrexfio next in the A to Z list
Eltroxin next in the A to Z list
Elranatamab next in the A to Z list
EluRyng next in the A to Z list
Elplat next in the A to Z list
Elvanse next in the A to Z list
Eloxatin next in the A to Z list
Elvitegravir 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 EltrombopagThe 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. Eltrombopag: adverse event reports that FDA received. https://reportedreactions.com/drug/eltrombopag/ 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 Eltrombopag as a suspect or interacting product. The 1,013 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 Eltrombopag 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 Eltrombopag?

No. It is a count of what people reported to FDA: 2,704 reports from September 2008 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?

Other health professional (43.3%), physician (40.3%) and consumer or non-health professional (12.2%). 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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