Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

P2Y12 platelet inhibitor adverse event reports that FDA received for the drugs of this class

Kind of class
Pharmacologic class (FDA Established Pharmacologic Class)
Drug pages
8

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 . The data have the reports that FDA received through .

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 .

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 .

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

P2Y12 platelet inhibitor is a pharmacologic class: an FDA Established Pharmacologic Class. The class has 8 drug pages on this site.

From January 2004 to June 2026, FDA received 99,787 adverse event reports that name a drug of the class. In these reports the drug is a suspect or interacting product. A report that names two drugs of the class counts one time for each.

FDA received 3,655 reports in the 12 months to June 2026 and 4,225 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.

Pharmacologic class

The Established Pharmacologic Class (EPC) of FDA is the class on the label of a drug. The site puts a drug in the class that its reports have most often.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs of the class

The rows are in order of name. A brand name and its generic name are separate rows, because reporters name them separately.

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 .

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 . The site read the page on .

Drug pages of the class P2Y12 platelet inhibitor, in order of name
DrugName typeReportsReports, 12 months to June 2026
BrilintaTicagrelorBrand name17,760210
ClopidogrelGeneric name29,8161,800
Clopidogrel bisulfateGeneric name6,901370
EffientPrasugrel hydrochlorideBrand name5,82045
PlavixClopidogrelBrand name31,050346
PrasugrelGeneric name97762
Prasugrel hydrochlorideGeneric name1,29516
TicagrelorGeneric name6,168806

Reaction lookup

These are the reaction terms that the reports of the class record. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 2,281 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 99,670 of the 99,787 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.

The table shows the first 50 of 2,281 terms.

Reaction terms in the reports that name a P2Y12 platelet inhibitor drug, most reports first
Reaction term (MedDRA) and plain meaningReportsShare of the 99,787 reports
Gastrointestinal haemorrhagebleeding in the stomach or bowel8,5468.6%
Dyspnoeashortness of breath6,5246.5%
Anaemialow red blood cells4,7114.7%
Myocardial infarctionheart attack4,4564.5%
Drug interactionan interaction between medicines4,4024.4%
Haemorrhagebleeding4,1634.2%
Deaththe patient died; cause not stated by this term3,2943.3%
Fatiguetiredness3,2603.3%
Dizzinesslight-headedness or unsteadiness3,2093.2%
Contusiona bruise3,0503.1%
Epistaxisnosebleed3,0133%
Drug ineffectivethe medicine did not work as expected2,9603%
Off label useused for a purpose or in a way not on the label2,8852.9%
Chest pain2,8142.8%
Astheniaweakness or lack of energy2,7032.7%
Cerebral haemorrhage2,5112.5%
Nauseafeeling sick2,3862.4%
Cerebrovascular accidentstroke2,3672.4%
Melaenablack tarry stools2,3012.3%
Falla fall2,2852.3%
Haemoglobin decreasedlow haemoglobin2,1122.1%
Headachehead pain2,0952.1%
Rectal haemorrhage2,0212%
Malaisegeneral feeling of being unwell1,9712%
Diarrhoealoose or frequent stools1,9482%
Vomitingbeing sick1,8111.8%
Haematocheziablood in the stool1,7891.8%
Upper gastrointestinal haemorrhage1,7521.8%
Haematuriablood in the urine1,6791.7%
Hypotensionlow blood pressure1,6411.6%
Haematomaa collection of blood under the skin or in tissue1,5591.6%
Rashskin rash1,5521.6%
Acute myocardial infarction1,5371.5%
Pruritusitching1,5121.5%
Painpain, site not specified1,4701.5%
Labelled drug-drug interaction medication error1,4621.5%
Acute kidney injurysudden loss of kidney function1,4501.5%
Haematemesis1,4451.4%
Abdominal painstomach or belly pain1,4121.4%
Cough1,3741.4%
Vascular stent thrombosis1,3381.3%
Chest discomfort1,3211.3%
Atrial fibrillationan irregular heart rhythm1,2831.3%
Abdominal pain upperupper stomach pain1,2591.3%
Weight decreasedweight loss1,2571.3%
Angina pectoris1,2131.2%
Pain in extremitypain in an arm or leg1,2041.2%
Subdural haematoma1,2001.2%
Condition aggravatedthe condition being treated got worse1,1991.2%
Hypertensionhigh blood pressure1,1891.2%

Download all 2,281 terms of the class (CSV)

The counts add to more than 99,787 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 .

Reports by month

Reports that name a P2Y12 platelet inhibitor drug, by month, five years to June 2026
05001,00020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Outcomes, patients and reporters

Outcomes in the reports of the class P2Y12 platelet inhibitor
OutcomeReportsShareShare as a bar
Death12,89912.9%
Life-threatening7,8117.8%
Hospitalization (initial or prolonged)46,75746.9%
Disability or Permanent Damage2,4592.5%
Congenital Anomaly/Birth Defect530.1%
Other Serious (Important Medical Events)49,99450.1%
Not serious11,68411.7%

An outcome in a report is not proof that a drug was the cause. The reporter gives the outcome, and FDA does not verify it. A report can have more than one outcome. 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 .

Age of the patient in the reports of the class P2Y12 platelet inhibitor
AgeReportsShareShare as a bar
Under 2910.1%
2 to 11820.1%
12 to 17920.1%
18 to 442,5352.5%
45 to 6420,05120.1%
65 to 7420,72720.8%
75 and over24,93325%
Age not given31,27631.3%
Type of reporter in the reports of the class P2Y12 platelet inhibitor
ReporterReportsShareShare as a bar
Physician28,09428.2%
Pharmacist8,5288.5%
Other health professional20,42120.5%
Lawyer4250.4%
Consumer or non-health professional37,28037.4%
Not given5,0395%

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. P2Y12 platelet inhibitor: adverse event reports that FDA received. https://reportedreactions.com/class/p2y12-platelet-inhibitor/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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.

The class of a drug is the Established Pharmacologic Class that openFDA attaches to its reports most often. When the reports have none, it is the class in the NDC Directory. 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

Which drugs are in the P2Y12 platelet inhibitor class on this site?

Brilinta, Clopidogrel, Clopidogrel bisulfate, Effient, Plavix, Prasugrel and 2 more, in order of name. The class of a drug comes from the pharmacologic class (EPC) on its FDA label.

Can the table of drugs rank the drugs?

No. FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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 .

Drugs also differ in the conditions that they treat and in their time on the market.

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.