Clopidogrel adverse event reports that FDA received

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

Name type: Generic name
Class: P2Y12 platelet inhibitor
Also reported as: Clopidogrel 75mg, Clopidogrel Tablets Usp, Clopidogrel 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 January 2004 to June 2026, FDA received 29,816 adverse event reports that name Clopidogrel. In these reports the drug is a suspect or interacting product.

In the same period, 58,881 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,800 reports in the 12 months to June 2026 and 1,865 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, 1,800 (0.1%) name Clopidogrel. Reports from consumers or other non-health professionals were 17.3% of the reports that name Clopidogrel 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 Clopidogrel 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 418 reports that name Clopidogrel.
In January to March 2026, FDA received 406.
In April to June 2025, FDA received 464.

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 1,647 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 29,761 of the 29,816 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 1,647 terms.

Reaction terms in the reports that name Clopidogrel, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 29,816 reports
Anaemialow red blood cells	2,260	7.6%
Drug interactionan interaction between medicines	2,115	7.1%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	1,695	5.7%
Dyspnoeashortness of breath	1,374	4.6%
Drug ineffectivethe medicine did not work as expected	1,279	4.3%
Dizzinesslight-headedness or unsteadiness	1,118	3.7%
Melaenablack tarry stools	1,100	3.7%
Fatiguetiredness	1,085	3.6%
Labelled drug-drug interaction medication error	1,040	3.5%
Haematocheziablood in the stool	1,027	3.4%
Haemorrhagebleeding	1,003	3.4%
Haemoglobin decreasedlow haemoglobin	876	2.9%
Epistaxisnosebleed	853	2.9%
Nauseafeeling sick	841	2.8%
Falla fall	835	2.8%
Cerebral haemorrhage	807	2.7%
Rectal haemorrhage	792	2.7%
Vomitingbeing sick	780	2.6%
Haematemesis	765	2.6%
Astheniaweakness or lack of energy	762	2.6%
Haematuriablood in the urine	760	2.5%
Diarrhoealoose or frequent stools	749	2.5%
Abdominal painstomach or belly pain	730	2.4%
Myocardial infarctionheart attack	730	2.4%
General physical health deteriorationgeneral decline in health	720	2.4%
Off label useused for a purpose or in a way not on the label	703	2.4%
Headachehead pain	698	2.3%
Hypotensionlow blood pressure	683	2.3%
Upper gastrointestinal haemorrhage	662	2.2%
Haematomaa collection of blood under the skin or in tissue	650	2.2%
Subdural haematoma	636	2.1%
Malaisegeneral feeling of being unwell	599	2%
Pruritusitching	571	1.9%
Condition aggravatedthe condition being treated got worse	542	1.8%
Abdominal pain upperupper stomach pain	540	1.8%
Chest pain	527	1.8%
Cerebrovascular accidentstroke	526	1.8%
Contusiona bruise	500	1.7%
Acute myocardial infarction	495	1.7%
Rashskin rash	477	1.6%
Acute kidney injurysudden loss of kidney function	450	1.5%
Arthralgiajoint pain	432	1.4%
Oedema peripheralswelling of the legs, ankles or hands	432	1.4%
Atrial fibrillationan irregular heart rhythm	429	1.4%
Haemorrhage intracranial	424	1.4%
Cough	409	1.4%
Syncopefainting	405	1.4%
Haemoptysiscoughing up blood	397	1.3%
Vascular stent thrombosis	391	1.3%
Angina pectoris	388	1.3%

Download all 1,647 terms of Clopidogrel (CSV)

The counts add to more than 29,816 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 Clopidogrel with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Clopidogrel (this page)	Generic name	29,816
Plavix	Brand name	31,050

Sum of the separately reported names: 60,866. 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 Clopidogrel, 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	79	74	13	17	51	5	0	16	5
2005	100	98	21	18	71	5	0	21	2
2006	220	215	26	27	152	5	0	52	5
2007	271	268	55	44	179	11	0	84	3
2008	301	293	57	48	191	16	0	74	8
2009	361	350	86	43	166	7	1	142	11
2010	227	220	48	22	135	14	0	73	7
2011	404	399	88	59	242	15	0	160	5
2012	568	507	94	63	249	33	0	236	61
2013	889	851	112	124	422	38	4	443	38
2014	987	945	119	105	452	45	0	527	42
2015	1,206	1,148	154	100	587	38	0	570	58
2016	1,596	1,485	141	103	760	51	0	838	111
2017	1,514	1,420	171	180	698	76	0	881	94
2018	3,010	2,882	329	306	1,793	67	7	1,614	128
2019	3,609	3,488	385	433	2,162	110	6	2,026	121
2020	3,165	3,089	312	306	2,025	85	0	1,651	76
2021	2,449	2,371	197	251	1,428	59	1	1,528	78
2022	2,071	2,021	239	206	1,300	51	3	1,268	50
2023	1,790	1,722	241	207	874	59	1	1,223	68
2024	1,849	1,721	157	178	836	65	0	1,226	128
2025	2,187	2,039	221	240	940	75	0	1,591	148
2026	963	907	118	153	449	12	0	651	56

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 Clopidogrel, 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 Clopidogrel, by the year in which FDA received them
Year	Reports
2004	71
2005	75
2006	235
2007	266
2008	324
2009	352
2010	228
2011	408
2012	648
2013	903
2014	987
2015	1,328
2016	1,672
2017	1,618
2018	3,210
2019	3,725
2020	3,198
2021	2,408
2022	1,974
2023	1,630
2024	1,823
2025	1,909
2026	824

Reports that name Clopidogrel, 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 Clopidogrel
Age	Reports	Share
Under 2	44	0.1%
2 to 11	50	0.2%
12 to 17	56	0.2%
18 to 44	979	3.3%
45 to 64	5,350	17.9%
65 to 74	6,422	21.5%
75 and over	9,751	32.7%
Age not given	7,164	24%

Sex of the patient in the reports that name Clopidogrel
Sex	Reports	Share
Female	9,956	33.4%
Male	14,728	49.4%
Unknown or not given	5,132	17.2%

Type of reporter in the reports that name Clopidogrel
Reporter	Reports	Share
Physician	10,263	34.4%
Pharmacist	4,594	15.4%
Other health professional	9,076	30.4%
Lawyer	31	0.1%
Consumer or non-health professional	5,159	17.3%
Not given	693	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Clopidogrel record
Indication as recorded (MedDRA)	Reports	Share
Antiplatelet therapy	2,841	9.5%
Thrombosis prophylaxis	935	3.1%
Anticoagulant therapy	795	2.7%
Acute myocardial infarction	640	2.1%
Cerebrovascular accident	626	2.1%
Prophylaxis	585	2%

The reporter fills in the indication, and the field is often empty. Each share is of all 29,816 reports.

Drugs in the same reports

Other drugs that the reports of Clopidogrel name, in any role, in order of name
Drug	Reports that name the two
Acetylsalicylic Acid	3,433
Amlodipine	2,045
Aspirin	8,811
Atorvastatin	4,826
Bisoprolol	2,897
Furosemide	2,190
Metoprolol	1,850
Pantoprazole	2,026
Ramipril	2,622
Simvastatin	2,358

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

Plavix same ingredient
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Clopidogrel bisulfate same class
Effient same class
Kengreal same class
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Clonidine hydrochloride next in the A to Z list
Clopine next in the A to Z list
Clonidine hcl next in the A to Z list
Clopixol next in the A to Z list
Clonidine next in the A to Z list
Clorazepate dipotassium 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 ClopidogrelThe 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. Clopidogrel: adverse event reports that FDA received. https://reportedreactions.com/drug/clopidogrel/ 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 Clopidogrel as a suspect or interacting product. The 58,881 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 Clopidogrel 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 Clopidogrel?

No. It is a count of what people reported to FDA: 29,816 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 (34.4%), other health professional (30.4%) and consumer or non-health professional (17.3%). 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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