Drugs › P2Y12 platelet inhibitor
Generic name
Prasugrel: adverse event reports filed with FDA
977 reports list it as a suspect or interacting product, 2009–2026. Class: P2Y12 platelet inhibitor. Also reported as Prasugrel Tablets.
- 977
- reports as suspect product
- 0% of all reports · about 57 a year
- 62
- reports, 12 months to June 2026
- 81 in the 12 months before
- 91.2%
- marked serious by the reporter
- 88.3% across the class
- 17.4%
- record death among outcomes, as reported
- 170 reports · not verified by FDA
977 adverse event reports received by FDA list prasugrel, a generic name as a suspect or interacting product, from June 2009 to May 2026. A further 1,454 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 62 reports listed it, down 23% from 81 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 57 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the P2Y12 platelet inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (5.7%), myocardial infarction (5.6%) and drug interaction (5.4%). A report can list several reactions, so shares add to more than 100%; 332 different terms appear across these reports. Drug ineffective is recorded in 5.7% of these reports, a larger share than in the median P2Y12 platelet inhibitor drug (3.2%).
91.2% of the reports are marked serious by the reporter (88.3% across the class); 17.4% record death among the outcomes and 50.9% record hospitalisation, as reported. 35.7% of the reports came from physicians, and the largest patient age group is 45 to 64 (30.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Prasugrel reports recording the termmedian drug in p2y12 platelet inhibitor
- Drug ineffectivethe medicine did not work as expected5.7%56
- Myocardial infarctionheart attack5.6%55
- Drug interactionan interaction between medicines5.4%53
- Gastrointestinal haemorrhagebleeding in the stomach or bowel4.6%45
- Epistaxisnosebleed4.5%44
- Haemorrhagebleeding4.2%41
- Off label useused for a purpose or in a way not on the label4.1%40
- Vascular stent thrombosis4%39
- Nauseafeeling sick3.7%36
- Dyspnoeashortness of breath3.4%33
- Chest painchest pain3.3%32
- Drug resistance3.3%32
- Hypertensionhigh blood pressure3.3%32
- Haematomaa collection of blood under the skin or in tissue3.1%30
- Headachehead pain3%29
- Anaemialow red blood cells2.8%27
- Cerebral haemorrhage2.7%26
- Dizzinesslight-headedness or unsteadiness2.6%25
- Completed suicidedeath by suicide2.5%24
- Drug administration errora mistake in giving the medicine2.3%22
- Vascular pseudoaneurysm2.3%22
- Melaenablack tarry stools2.1%21
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2%20
- Coronary artery disease1.9%19
- Hyperhidrosisexcessive sweating1.9%19
- Rashskin rash1.9%19
- Thrombosis1.9%19
Top 30 of 332 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the p2y12 platelet inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 99,787 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 42.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Antiplatelet therapy | 150 | 15.4% |
| Acute myocardial infarction | 41 | 4.2% |
| Thrombosis prophylaxis | 36 | 3.7% |
| Coronary arterial stent insertion | 31 | 3.2% |
| Myocardial infarction | 28 | 2.9% |
| Coronary artery disease | 16 | 1.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 977 reports.
In context
| Measure | Prasugrel | P2Y12 platelet inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 977 | 99,787 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 62 | — | 1,332,454 |
| Marked serious | 91.2% | 88.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 174 | 129 | 91 |
| Hospitalisation recorded, per 1,000 reports | 509 | 469 | 213 |
| Consumer-filed share | 16.5% | 37.4% | 45.8% |
| Top term, share of reports | Drug ineffective 5.7% | median 3.2% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the p2y12 platelet inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Plavix | brand | 31,050 | 346 | 91.6% |
| Clopidogrel | generic | 29,816 | 1,800 | 95.6% |
| Brilinta | brand | 17,760 | 210 | 67.5% |
| Clopidogrel bisulfate | generic | 6,901 | 370 | 96% |
| Ticagrelor | generic | 6,168 | 806 | 97.8% |
| Effient | brand | 5,820 | 45 | 75.1% |
| Prasugrel hydrochloride | generic | 1,295 | 16 | 95.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Prasugrel reports
How many adverse event reports has FDA received for Prasugrel?
977 reports list Prasugrel as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 62 of them arrived in the latest 12 months. Another 1,454 list it only as a concomitant medication.
What reactions are recorded in Prasugrel reports?
drug ineffective (5.7%), myocardial infarction (5.6%), drug interaction (5.4%), labelled drug-drug interaction medication error (5.2%) and acute myocardial infarction (4.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Prasugrel was responsible.
How serious are the reports?
91.2% are marked serious by the reporter. Among the outcomes recorded, 17.4% of reports include death and 50.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (35.7%), other health professional (35.6%) and consumer or non-health professional (16.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Prasugrel rising?
62 reports in the 12 months to June 2026, down 23% from 81 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Prasugrel was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Prasugrel?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Prasugrel as a suspect or interacting product; reports listing it only as a concomitant medication (1,454) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.