Argatroban adverse event reports that FDA received

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

Name type: Generic name
Class: Anti-coagulant
Also reported as: Argatroban 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.

Reports on file

From January 2004 to June 2026, FDA received 1,062 adverse event reports that name Argatroban. In these reports the drug is a suspect or interacting product.

In the same period, 437 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 52 reports in the 12 months to June 2026 and 44 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 Argatroban 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 10 reports that name Argatroban.
In January to March 2026, FDA received 11.
In April to June 2025, FDA received 21.

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 83 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 1,060 of the 1,062 reports (99.8%).

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 83 terms.

Reaction terms in the reports that name Argatroban, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,062 reports
Drug ineffectivethe medicine did not work as expected	119	11.2%
Heparin-induced thrombocytopenia	118	11.1%
International normalised ratio increasedblood clotting slower than intended (raised INR)	97	9.1%
Activated partial thromboplastin time prolonged	77	7.3%
Haemorrhagebleeding	63	5.9%
Coagulation time prolonged	62	5.8%
Off label useused for a purpose or in a way not on the label	50	4.7%
Deep vein thrombosisa blood clot in a deep vein	42	4%
Pulmonary embolisma blood clot in the lung	37	3.5%
Thrombosis	36	3.4%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	35	3.3%
Thrombocytopenialow platelets	32	3%
Disseminated intravascular coagulation	31	2.9%
Cerebral infarction	28	2.6%
Cerebral haemorrhage	23	2.2%
Cardiac arrestthe heart stopped	22	2.1%
Coagulopathy	19	1.8%
Respiratory failurethe lungs could not supply enough oxygen	17	1.6%
Cardiogenic shockshock from the heart failing to pump	16	1.5%
Aspartate aminotransferase increasedraised liver enzyme (AST)	15	1.4%
Multiple organ dysfunction syndromeseveral organs failing	15	1.4%
Hepatic function abnormal	14	1.3%
Hypotensionlow blood pressure	14	1.3%
Subarachnoid haemorrhage	14	1.3%
Alanine aminotransferase increasedraised liver enzyme (ALT)	12	1.1%
Pneumonialung infection	12	1.1%
Renal failurekidney failure	12	1.1%
Deaththe patient died; cause not stated by this term	11	1%
Haemoglobin decreasedlow haemoglobin	11	1%
Hypofibrinogenaemia	11	1%
Renal failure acute	11	1%
Atrial fibrillationan irregular heart rhythm	10	0.9%
Cardiac ventricular thrombosis	10	0.9%
Condition aggravatedthe condition being treated got worse	10	0.9%
Haematemesis	10	0.9%
Platelet count decreasedlow platelet count	10	0.9%
Anaphylactic reactiona severe, sudden allergic reaction	9	0.8%
Drug interactionan interaction between medicines	9	0.8%
Sepsisa severe body-wide response to infection	9	0.8%
Septic shockshock arising from infection	9	0.8%
Activated partial thromboplastin time abnormal	8	0.8%
Activated partial thromboplastin time shortened	8	0.8%
Anaemialow red blood cells	8	0.8%
Cardio-respiratory arrestthe heart and breathing stopped	8	0.8%
Haematocheziablood in the stool	8	0.8%
Shock haemorrhagic	8	0.8%
Blood alkaline phosphatase increased	7	0.7%
Blood bilirubin increased	7	0.7%
Cardiac failureheart failure	7	0.7%
Coagulation time abnormal	7	0.7%

Download all 83 terms of Argatroban (CSV)

The counts add to more than 1,062 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 Argatroban, 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	18	16	6	3	8	0	0	3	2
2005	16	10	2	4	4	0	0	3	6
2006	48	37	15	2	21	1	0	7	11
2007	102	59	17	8	24	3	0	20	43
2008	50	30	3	4	13	3	1	13	20
2009	52	50	9	3	31	1	0	31	2
2010	70	63	19	8	27	2	0	33	7
2011	60	43	20	5	20	1	0	25	17
2012	51	42	18	6	15	0	0	27	9
2013	23	22	8	1	9	0	0	13	1
2014	35	28	8	0	9	1	0	17	7
2015	30	28	5	2	9	1	0	22	2
2016	17	15	8	3	3	0	0	12	2
2017	58	55	10	8	24	2	1	37	3
2018	39	34	11	8	9	0	0	23	5
2019	63	59	17	7	22	0	1	34	4
2020	57	54	10	11	17	0	0	37	3
2021	37	33	6	8	18	1	0	16	4
2022	54	46	9	10	28	2	1	24	8
2023	55	54	7	10	38	0	0	28	1
2024	41	40	6	10	21	0	0	28	1
2025	63	63	8	16	34	2	0	35	0
2026	23	23	9	3	6	0	0	15	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 Argatroban, 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 Argatroban, by the year in which FDA received them
Year	Reports
2004	9
2005	13
2006	28
2007	54
2008	33
2009	28
2010	173
2011	77
2012	58
2013	22
2014	36
2015	27
2016	20
2017	57
2018	43
2019	71
2020	56
2021	37
2022	49
2023	51
2024	41
2025	58
2026	21

Reports that name Argatroban, 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 Argatroban
Age	Reports	Share
Under 2	6	0.6%
2 to 11	12	1.1%
12 to 17	4	0.4%
18 to 44	156	14.7%
45 to 64	288	27.1%
65 to 74	181	17%
75 and over	149	14%
Age not given	266	25%

Sex of the patient in the reports that name Argatroban
Sex	Reports	Share
Female	417	39.3%
Male	493	46.4%
Unknown or not given	152	14.3%

Type of reporter in the reports that name Argatroban
Reporter	Reports	Share
Physician	266	25%
Pharmacist	187	17.6%
Other health professional	461	43.4%
Lawyer	6	0.6%
Consumer or non-health professional	102	9.6%
Not given	40	3.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 60.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Argatroban record
Indication as recorded (MedDRA)	Reports	Share
Heparin-induced thrombocytopenia	332	31.3%
Anticoagulant therapy	133	12.5%
Cerebral infarction	36	3.4%
Thrombosis prophylaxis	21	2%
Pulmonary embolism	18	1.7%
Deep vein thrombosis	16	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,062 reports.

Pages near this one

Anticoagulant Sodium Citrate same class
Bivalirudin same class
Alka-Seltzer Original same class
Clenpiq same class
Dalteparin sodium same class
Arestin next in the A to Z list
Aricept next in the A to Z list
Aredia next in the A to Z list
Arikayce next in the A to Z list
Arcoxia next in the A to Z list
Arimidex next in the A to Z list
Arcalyst 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 ArgatrobanThe 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. Argatroban: adverse event reports that FDA received. https://reportedreactions.com/drug/argatroban/ 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 Argatroban as a suspect or interacting product. The 437 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 Argatroban 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 Argatroban?

No. It is a count of what people reported to FDA: 1,062 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?

Other health professional (43.4%), physician (25%) and pharmacist (17.6%). 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.

To the top of the page