Prasugrel side effects: what 2,376 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,376 reports · 87% serious · 257 with death outcome · 33% female
Used for
Prasugrel tablets are a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ).
What it is
Prasugrel tablets, USP contain prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel tablets are formulated as the h.
Boxed warning
BLEEDING RISK • Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . • Do not use prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications (4.1 , 4.2) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 46 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acute myocardial infarction | 105 | 31.4 26.0–37.9ROR 32.8 · χ² 3,054 / p <1e-300 | 31.1 EB05 26.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.8 | no trial data cached |
| Coronary artery occlusion | 34 | 21.8 15.6–30.5ROR 22.1 · χ² 654 / p 2e-144 | 21.5 EB05 16.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.0 | no trial data cached |
| Cardiogenic shock | 25 | 15.5 10.5–22.9ROR 15.6 · χ² 324 / p 9e-73 | 15.1 EB05 10.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.7 · ♀ 54% (drug 33%) · 100% clinician | no trial data cached |
| Haematoma | 44 | 15.0 11.2–20.0ROR 15.2 · χ² 559 / p 8e-124 | 14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · ♀ 62% (drug 33%) | no trial data cached |
| Hypomagnesaemia | 22 | 14.0 9.2–21.3ROR 14.1 · χ² 253 / p 3e-57 | 13.4 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 95% clinician | no trial data cached |
| Coronary artery disease | 48 | 13.9 10.5–18.4ROR 14.2 · χ² 562 / p 2e-124 | 13.7 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Drug resistance | 40 | 13.8 10.1–18.7ROR 14.0 · χ² 461 / p 2e-102 | 13.5 EB05 10.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 · 98% clinician | no trial data cached |
| Subarachnoid haemorrhage | 15 | 13.0 7.8–21.5ROR 13.1 · χ² 154 / p 1e-35 | 11.8 EB05 6.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Melaena (black stool) | 30 | 12.0 8.4–17.1ROR 12.2 · χ² 292 / p 9e-66 | 11.5 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 8% (drug 33%) | no trial data cached |
| Ventricular extrasystoles | 14 | 11.9 7.1–20.1ROR 12.0 · χ² 129 / p 4e-30 | 10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Upper gastrointestinal haemorrhage | 22 | 11.5 7.6–17.5ROR 11.6 · χ² 201 / p 7e-46 | 10.7 EB05 7.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · 91% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 49 | 10.4 7.9–13.7ROR 10.6 · χ² 407 / p 7e-91 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 92% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 22 | 10.3 6.8–15.6ROR 10.4 · χ² 175 / p 2e-40 | 9.4 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 95% clinician | no trial data cached |
| Haemorrhage intracranial | 17 | 10.0 6.2–16.1ROR 10.1 · χ² 129 / p 4e-30 | 8.8 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Obstructive airways disorder | 12 | 9.5 5.4–16.7ROR 9.5 · χ² 83 / p 4e-20 | 7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Eye haemorrhage | 14 | 9.2 5.5–15.6ROR 9.3 · χ² 95 / p 1e-22 | 7.8 EB05 4.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 26 | 9.0 6.1–13.2ROR 9.1 · χ² 177 / p 1e-40 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 80% (drug 33%) · 100% clinician | no trial data cached |
| Myocardial infarction (heart attack) | 175 | 8.8 7.6–10.1ROR 9.4 · χ² 1,210 / p 3e-265 | 8.7 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.8 | no trial data cached |
| Cerebral haemorrhage | 34 | 8.4 6.0–11.7ROR 8.5 · χ² 214 / p 8e-49 | 7.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 100% clinician | no trial data cached |
| Gingival bleeding | 13 | 8.4 4.9–14.4ROR 8.4 · χ² 77 / p 7e-19 | 6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Sleep apnoea syndrome | 18 | 8.3 5.2–13.2ROR 8.4 · χ² 109 / p 1e-25 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Subdural haematoma | 13 | 8.0 4.6–13.7ROR 8.0 · χ² 73 / p 8e-18 | 6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Angina pectoris | 26 | 8.0 5.4–11.7ROR 8.0 · χ² 151 / p 4e-35 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Ejection fraction decreased | 14 | 7.9 4.7–13.4ROR 8.0 · χ² 78 / p 5e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Myocardial ischaemia | 10 | 7.7 4.1–14.3ROR 7.7 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.1 | no trial data cached |
| Diplopia (double vision) | 22 | 7.5 4.9–11.3ROR 7.5 · χ² 117 / p 1e-27 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 91% clinician | no trial data cached |
| Hypercalcaemia | 10 | 7.2 3.9–13.3ROR 7.2 · χ² 47 / p 4e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hepatic steatosis | 15 | 7.1 4.3–11.8ROR 7.2 · χ² 73 / p 7e-18 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Drug administration error | 25 | 7.1 4.8–10.5ROR 7.2 · χ² 125 / p 3e-29 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 13.3 | no trial data cached |
| Epistaxis (nosebleed) | 59 | 7.0 5.4–8.9ROR 7.1 · χ² 296 / p 2e-66 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Gastrointestinal haemorrhage | 65 | 6.8 5.4–8.7ROR 7.0 · χ² 318 / p 2e-71 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Prostatic specific antigen increased | 10 | 6.4 3.4–11.8ROR 6.4 · χ² 40 / p 1e-10 | 5.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Drug-induced liver injury | 22 | 6.3 4.2–9.5ROR 6.3 · χ² 93 / p 3e-22 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 95% clinician | no trial data cached |
| Blood test abnormal | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Liver function test abnormal | 20 | 6.0 3.9–9.3ROR 6.1 · χ² 79 / p 3e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Diabetic ketoacidosis | 16 | 5.9 3.6–9.6ROR 5.9 · χ² 60 / p 4e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Drug interaction | 103 | 5.7 4.7–6.9ROR 5.9 · χ² 400 / p 2e-89 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Haematuria (blood in urine) | 22 | 5.7 3.7–8.6ROR 5.7 · χ² 80 / p 2e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Pneumonitis | 16 | 5.2 3.2–8.5ROR 5.3 · χ² 51 / p 6e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Blood pressure abnormal | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Myocardial infarction (heart attack) | 175 | 8.8 7.6–10.1ROR 9.4 · χ² 1,210 / p 3e-265 | 8.7 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.8 | no trial data cached |
| Acute myocardial infarction | 105 | 31.4 26.0–37.9ROR 32.8 · χ² 3,054 / p <1e-300 | 31.1 EB05 26.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.8 | no trial data cached |
| Drug interaction | 103 | 5.7 4.7–6.9ROR 5.9 · χ² 400 / p 2e-89 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Gastrointestinal haemorrhage | 65 | 6.8 5.4–8.7ROR 7.0 · χ² 318 / p 2e-71 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Epistaxis (nosebleed) | 59 | 7.0 5.4–8.9ROR 7.1 · χ² 296 / p 2e-66 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Haemorrhage | 57 | 4.8 3.7–6.2ROR 4.9 · χ² 169 / p 6e-39 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.4 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 49 | 10.4 7.9–13.7ROR 10.6 · χ² 407 / p 7e-91 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 92% clinician | no trial data cached |
| Coronary artery disease | 48 | 13.9 10.5–18.4ROR 14.2 · χ² 562 / p 2e-124 | 13.7 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Haematoma | 44 | 15.0 11.2–20.0ROR 15.2 · χ² 559 / p 8e-124 | 14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · ♀ 62% (drug 33%) | no trial data cached |
| Drug resistance | 40 | 13.8 10.1–18.7ROR 14.0 · χ² 461 / p 2e-102 | 13.5 EB05 10.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 · 98% clinician | no trial data cached |
| Thrombosis | 36 | 3.9 2.8–5.4ROR 4.0 · χ² 76 / p 1e-18 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.6 · ♀ 64% (drug 33%) | no trial data cached |
| Cerebral haemorrhage | 34 | 8.4 6.0–11.7ROR 8.5 · χ² 214 / p 8e-49 | 7.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 100% clinician | no trial data cached |
| Coronary artery occlusion | 34 | 21.8 15.6–30.5ROR 22.1 · χ² 654 / p 2e-144 | 21.5 EB05 16.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.0 | no trial data cached |
| Melaena (black stool) | 30 | 12.0 8.4–17.1ROR 12.2 · χ² 292 / p 9e-66 | 11.5 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 8% (drug 33%) | no trial data cached |
| Angina pectoris | 26 | 8.0 5.4–11.7ROR 8.0 · χ² 151 / p 4e-35 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hypomagnesaemia — n=22, PRR 14.0
- Melaena — n=30, PRR 12.0
- Rhabdomyolysis — n=49, PRR 10.4
- Hypocalcaemia — n=22, PRR 10.3
- Drug reaction with eosinophilia and systemic symptoms — n=26, PRR 9.0
- Cerebral haemorrhage — n=34, PRR 8.4
- Angina pectoris — n=26, PRR 8.0
- Diplopia — n=22, PRR 7.5
- Drug-induced liver injury — n=22, PRR 6.3
- Haematuria — n=22, PRR 5.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Prasugrel?
In FDA FAERS, the most frequently co-reported reaction terms for Prasugrel are myocardial infarction, acute myocardial infarction, gastrointestinal haemorrhage, epistaxis, haemorrhage, rhabdomyolysis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Prasugrel have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: BLEEDING RISK • Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . • Do not use prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications (4.1 , 4.2) ] .
Do FAERS signals prove that Prasugrel causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 41a4e332-6725-4cb7-940a-8291cf56cfe4, effective 20220629; matched on
openfda.generic_name.exact:"PRASUGREL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 86 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.