What the label lists and what reports show
Prasugrel side effects
Prasugrel's FDA label: “Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ).” FAERS holds 12,433 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is chest pain (550 reports).
- Generic listed
- Boxed warning
Check it at the source: the prasugrel FDA label on DailyMed (effective February 11, 2025, Panacea Biotec Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of prasugrel tablets?Prasugrel tablets can cause serious side effects, including: See "What is the most important information I should know about prasugrel tablets?" A blood clotting problem called thrombotic thrombocytopenic purpura (TTP). TTP can happen with prasugrel tablets, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital right away, because you may die. […]
Source: FDA drug label, Panacea Biotec Limited, effective February 11, 2025 (SPL set 944c195a-de24-a44c-8baa-84b624b5ddcb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsBleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ).
Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group
| Reaction | Prasugrel tablets (%) (N=6741) | Clopidogrel (%) (N=6716) |
|---|---|---|
| Hypertension | 7.5 | 7.1 |
| Hypercholesterolemia/Hyperlipidemia | 7.0 | 7.4 |
| Headache | 5.5 | 5.3 |
| Back pain | 5.0 | 4.5 |
| Dyspnea | 4.9 | 4.5 |
| Nausea | 4.6 | 4.3 |
| Dizziness | 4.1 | 4.6 |
| Cough | 3.9 | 4.1 |
| Hypotension | 3.9 | 3.8 |
| Fatigue | 3.7 | 4.8 |
| Non-cardiac chest pain | 3.1 | 3.5 |
| Atrial fibrillation | 2.9 | 3.1 |
| Bradycardia | 2.9 | 2.4 |
| Leukopenia (<4 x 10 9 WBC * /L) | 2.8 | 3.5 |
| Rash | 2.8 | 2.4 |
| Pyrexia | 2.7 | 2.2 |
| Peripheral edema | 2.7 | 3.0 |
| Pain in extremity | 2.6 | 2.6 |
| Diarrhea | 2.3 | 2.6 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.2 )] Thrombotic thrombocytopenic purpura [see Warnings and Precautions ( 5.4 )] Hypersensitivity including Angioedema [see Warnings and Precautions ( 5.5 )] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with prasugrel tablets (60 mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with prasugrel tablet was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300 mg loading dose and 75 mg once daily. …
Source: FDA drug label, Panacea Biotec Limited, effective February 11, 2025 (SPL set 944c195a-de24-a44c-8baa-84b624b5ddcb), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,433 reports list prasugrel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,110 are coded as a death and 5,102 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Prasugrel: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions