Prasugrel hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: P2Y12 platelet inhibitor
Also reported as: Prasugrel Hcl, Prasugrel Hydrochloride 10mg

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 July 2009 to June 2026, FDA received 1,295 adverse event reports that name Prasugrel hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 663 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 16 reports in the 12 months to June 2026 and 18 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, 16 (under 0.1%) name Prasugrel hydrochloride. Reports for female patients were 27% of the reports that name Prasugrel hydrochloride and 52.7% 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 Prasugrel hydrochloride 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 3 reports that name Prasugrel hydrochloride.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 3.

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 86 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 1,270 of the 1,295 reports (98.1%).

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 86 terms.

Reaction terms in the reports that name Prasugrel hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,295 reports
Vascular stent thrombosis	56	4.3%
Haemorrhagebleeding	54	4.2%
Chest pain	49	3.8%
Myocardial infarctionheart attack	46	3.6%
Acute myocardial infarction	45	3.5%
Anaemialow red blood cells	44	3.4%
Cerebral infarction	43	3.3%
Angina pectoris	42	3.2%
Thrombotic cerebral infarction	37	2.9%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	32	2.5%
Off label useused for a purpose or in a way not on the label	31	2.4%
Cerebral haemorrhage	26	2%
Thrombosis in devicea blood clot in the device	26	2%
Ischaemic stroke	24	1.9%
Cardiac failureheart failure	21	1.6%
Falla fall	20	1.5%
Deaththe patient died; cause not stated by this term	19	1.5%
Epistaxisnosebleed	19	1.5%
Haemoglobin decreasedlow haemoglobin	18	1.4%
Atrial fibrillationan irregular heart rhythm	16	1.2%
Cardiac tamponade	16	1.2%
Dyspnoeashortness of breath	16	1.2%
Pneumonialung infection	16	1.2%
Cardiac failure congestivecongestive heart failure	15	1.2%
Drug interactionan interaction between medicines	15	1.2%
Melaenablack tarry stools	15	1.2%
Angina unstable	13	1%
Embolic stroke	13	1%
Lacunar infarction	13	1%
Subdural haematoma	13	1%
Contusiona bruise	12	0.9%
Hospitalisationadmission to hospital	12	0.9%
Interstitial lung diseasescarring or inflammation of lung tissue	12	0.9%
Acute kidney injurysudden loss of kidney function	11	0.8%
Rashskin rash	11	0.8%
Transient ischaemic attack	11	0.8%
Coronary artery stenosis	10	0.8%
Hepatic function abnormal	10	0.8%
Liver disorder	10	0.8%
Haematomaa collection of blood under the skin or in tissue	9	0.7%
Pyrexiafever	9	0.7%
Vascular pseudoaneurysm	9	0.7%
Abdominal painstomach or belly pain	8	0.6%
Cardiac arrestthe heart stopped	8	0.6%
Hypersensitivityan allergic-type reaction	8	0.6%
Painpain, site not specified	8	0.6%
Pulmonary alveolar haemorrhage	8	0.6%
Acute coronary syndrome	7	0.5%
Astheniaweakness or lack of energy	7	0.5%
Femur fracture	7	0.5%

Download all 86 terms of Prasugrel hydrochloride (CSV)

The counts add to more than 1,295 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 Prasugrel with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Prasugrel	Generic name	977
Prasugrel hydrochloride (this page)	Generic name	1,295
Effient	Brand name	5,820

Sum of the separately reported names: 8,092. 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 Prasugrel hydrochloride, 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
2009	4	4	0	1	3	0	0	1	0
2010	127	127	9	11	112	1	0	33	0
2011	122	122	18	17	104	3	1	36	0
2012	69	69	9	5	36	2	0	37	0
2013	36	35	2	1	12	0	0	23	1
2014	30	29	3	4	17	0	0	14	1
2015	78	64	4	15	40	3	0	46	14
2016	85	85	17	16	48	4	0	54	0
2017	122	119	14	8	77	8	0	48	3
2018	126	121	24	9	68	6	0	64	5
2019	140	124	14	9	80	3	0	65	16
2020	111	101	18	12	51	4	0	60	10
2021	61	57	11	4	28	1	0	32	4
2022	98	94	12	6	51	5	0	54	4
2023	49	49	1	2	31	0	0	29	0
2024	9	9	1	1	6	1	0	4	0
2025	18	18	2	1	8	0	0	16	0
2026	10	10	1	1	6	0	0	7	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 Prasugrel hydrochloride, 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 Prasugrel hydrochloride, by the year in which FDA received them
Year	Reports
2009	4
2010	104
2011	120
2012	95
2013	40
2014	32
2015	84
2016	88
2017	126
2018	128
2019	142
2020	96
2021	65
2022	95
2023	41
2024	8
2025	19
2026	8

Reports that name Prasugrel hydrochloride, 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 Prasugrel hydrochloride
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.2%
12 to 17	2	0.2%
18 to 44	26	2%
45 to 64	222	17.1%
65 to 74	229	17.7%
75 and over	311	24%
Age not given	502	38.8%

Sex of the patient in the reports that name Prasugrel hydrochloride
Sex	Reports	Share
Female	350	27%
Male	750	57.9%
Unknown or not given	195	15.1%

Type of reporter in the reports that name Prasugrel hydrochloride
Reporter	Reports	Share
Physician	551	42.5%
Pharmacist	61	4.7%
Other health professional	113	8.7%
Lawyer	0	0%
Consumer or non-health professional	569	43.9%
Not given	1	0.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Prasugrel hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Acute coronary syndrome	223	17.2%
Acute myocardial infarction	103	8%
Angina pectoris	65	5%
Myocardial infarction	53	4.1%
Stent placement	40	3.1%
Antiplatelet therapy	39	3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,295 reports.

Pages near this one

Prasugrel same ingredient
Effient same ingredient
Ticagrelor same class
Plavix same class
Kengreal same class
Pravachol next in the A to Z list
Pramipexole dihydrochloride next in the A to Z list
Pravastatin next in the A to Z list
Pramipexole next in the A to Z list
Pravastatin sodium next in the A to Z list
Praluent next in the A to Z list
Praxbind 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 Prasugrel hydrochlorideThe 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. Prasugrel hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/prasugrel-hydrochloride/ 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 Prasugrel hydrochloride as a suspect or interacting product. The 663 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 Prasugrel hydrochloride 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 Prasugrel hydrochloride?

No. It is a count of what people reported to FDA: 1,295 reports from July 2009 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 (43.9%), physician (42.5%) and other health professional (8.7%). 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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