Prasugrel Hydrochloride side effects: what 10,097 FDA adverse event reports show
Drug class
Not stated in label
Who reports
10,097 reports · 75% serious · 857 with death outcome · 35% 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 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. 970 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 |
|---|---|---|---|---|---|---|
| In-stent coronary artery restenosis | 50 | 715.9 519.1–987.3ROR 719.5 · χ² 25,922 / p <1e-300 | 440.8 EB05 347.5 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=50 | no trial data cached |
| In-stent arterial restenosis | 13 | 633.8 340.3–1,180.2ROR 634.6 · χ² 5,798 / p <1e-300 | 282.9 EB05 175.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Arterial restenosis | 15 | 295.3 171.9–507.3ROR 295.8 · χ² 3,592 / p <1e-300 | 194.6 EB05 125.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Thrombotic cerebral infarction | 42 | 260.6 189.1–359.1ROR 261.7 · χ² 9,406 / p <1e-300 | 209.4 EB05 161.4 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · 76% consumer | no trial data cached |
| Platelet aggregation inhibition | 10 | 252.8 131.1–487.5ROR 253.0 · χ² 2,014 / p <1e-300 | 157.9 EB05 91.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Vessel puncture site haemorrhage | 26 | 243.1 162.0–364.9ROR 243.7 · χ² 5,389 / p <1e-300 | 187.6 EB05 134.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=26 · 81% consumer | no trial data cached |
| Coronary artery restenosis | 54 | 204.8 154.9–270.7ROR 205.9 · χ² 9,770 / p <1e-300 | 174.8 EB05 139.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=54 | no trial data cached |
| Platelet function test abnormal | 20 | 199.8 126.3–316.0ROR 200.2 · χ² 3,425 / p <1e-300 | 155.4 EB05 106.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Thrombosis in device | 284 | 194.9 172.8–219.8ROR 200.5 · χ² 49,849 / p <1e-300 | 175.9 EB05 159.4 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=283 | no trial data cached |
| Vessel puncture site haematoma | 16 | 181.0 108.6–301.7ROR 181.3 · χ² 2,469 / p <1e-300 | 139.1 EB05 90.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Vascular stent thrombosis | 109 | 117.6 97.0–142.5ROR 118.9 · χ² 11,807 / p <1e-300 | 109.2 EB05 93.0 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=108 · ♀ 12% (drug 35%) | no trial data cached |
| Puncture site haemorrhage | 33 | 101.8 71.8–144.3ROR 102.1 · χ² 3,041 / p <1e-300 | 92.0 EB05 68.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=31 · 85% consumer | no trial data cached |
| Myocardial rupture | 12 | 83.9 47.1–149.3ROR 84.0 · χ² 866 / p 1e-190 | 71.8 EB05 43.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Vascular stent occlusion | 15 | 79.2 47.3–132.5ROR 79.3 · χ² 1,040 / p 1e-228 | 69.8 EB05 44.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Vascular stent stenosis | 12 | 61.6 34.7–109.3ROR 61.7 · χ² 637 / p 9e-141 | 54.9 EB05 33.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Vascular pseudoaneurysm | 43 | 52.4 38.7–70.9ROR 52.6 · χ² 2,065 / p <1e-300 | 50.1 EB05 38.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=43 | no trial data cached |
| Retroperitoneal haemorrhage | 53 | 45.5 34.7–59.7ROR 45.7 · χ² 2,213 / p <1e-300 | 43.9 EB05 34.8 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=53 · 79% consumer | no trial data cached |
| Coronary artery thrombosis | 27 | 28.0 19.2–41.0ROR 28.1 · χ² 668 / p 1e-147 | 27.2 EB05 19.6 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=27 | no trial data cached |
| Haemorrhage intracranial | 173 | 24.2 20.9–28.1ROR 24.6 · χ² 3,783 / p <1e-300 | 23.9 EB05 21.0 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.4 · 78% consumer | no trial data cached |
| Bleeding time prolonged | 13 | 22.5 13.0–38.9ROR 22.5 · χ² 243 / p 4e-55 | 21.5 EB05 13.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Stent placement | 83 | 21.6 17.4–26.8ROR 21.8 · χ² 1,593 / p <1e-300 | 21.3 EB05 17.7 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · 74% consumer | no trial data cached |
| Angina unstable | 67 | 21.4 16.8–27.2ROR 21.6 · χ² 1,271 / p 1e-278 | 21.1 EB05 17.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious n=67 | no trial data cached |
| Coronary artery stenosis | 48 | 19.9 15.0–26.5ROR 20.0 · χ² 836 / p 4e-184 | 19.6 EB05 15.4 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=47 | no trial data cached |
| Angioplasty | 14 | 19.6 11.6–33.2ROR 19.6 · χ² 227 / p 2e-51 | 18.7 EB05 11.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Diverticulum intestinal haemorrhagic | 21 | 19.4 12.6–29.8ROR 19.5 · χ² 345 / p 2e-77 | 18.9 EB05 12.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=21 · ♀ 10% (drug 35%) | no trial data cached |
| Pericardial haemorrhage | 20 | 19.1 12.3–29.7ROR 19.2 · χ² 323 / p 2e-72 | 18.5 EB05 12.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Urinary bladder haemorrhage | 19 | 18.8 12.0–29.6ROR 18.9 · χ² 300 / p 1e-67 | 18.2 EB05 12.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Coronary artery occlusion | 121 | 18.4 15.4–22.0ROR 18.6 · χ² 1,955 / p <1e-300 | 18.2 EB05 15.6 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.1 | no trial data cached |
| Lacunar infarction | 21 | 18.4 12.0–28.2ROR 18.4 · χ² 325 / p 6e-73 | 17.8 EB05 12.1 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 · ♀ 14% (drug 35%) | no trial data cached |
| Venous occlusion | 16 | 18.3 11.2–29.9ROR 18.3 · χ² 243 / p 5e-55 | 17.6 EB05 11.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Coronary arterial stent insertion | 44 | 18.2 13.5–24.5ROR 18.3 · χ² 692 / p 8e-153 | 17.9 EB05 13.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=43 | no trial data cached |
| Thrombotic thrombocytopenic purpura | 29 | 17.2 11.9–24.7ROR 17.2 · χ² 422 / p 4e-94 | 16.8 EB05 12.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 | no trial data cached |
| Vascular occlusion | 17 | 16.8 10.5–27.1ROR 16.9 · χ² 236 / p 2e-53 | 16.1 EB05 10.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Large intestinal haemorrhage | 18 | 16.7 10.5–26.5ROR 16.7 · χ² 248 / p 4e-56 | 16.0 EB05 10.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Non-cardiac chest pain | 24 | 15.8 10.6–23.6ROR 15.8 · χ² 315 / p 9e-71 | 15.3 EB05 10.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Cardiac tamponade | 35 | 15.4 11.0–21.4ROR 15.4 · χ² 452 / p 1e-100 | 15.0 EB05 11.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=35 | no trial data cached |
| Retroperitoneal haematoma | 16 | 15.2 9.3–24.9ROR 15.2 · χ² 197 / p 4e-45 | 14.3 EB05 8.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Acute myocardial infarction | 214 | 15.1 13.2–17.3ROR 15.4 · χ² 2,788 / p <1e-300 | 15.0 EB05 13.4 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.5 | no trial data cached |
| Haemorrhage urinary tract | 18 | 14.8 9.3–23.5ROR 14.8 · χ² 217 / p 2e-49 | 14.0 EB05 8.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Incorrect storage of drug | 12 | 14.3 8.1–25.2ROR 14.3 · χ² 135 / p 2e-31 | 12.8 EB05 6.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=12 | 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) | 507 | 6.0 5.5–6.5ROR 6.3 · χ² 2,119 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.6 | no trial data cached |
| Gastrointestinal haemorrhage | 470 | 11.7 10.7–12.7ROR 12.2 · χ² 4,564 / p <1e-300 | 11.6 EB05 10.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · 77% consumer | no trial data cached |
| Chest pain | 457 | 5.1 4.7–5.6ROR 5.3 · χ² 1,522 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Haemorrhage | 453 | 9.0 8.3–9.9ROR 9.4 · χ² 3,229 / p <1e-300 | 8.9 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 · 73% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 431 | 1.6 1.4–1.7ROR 1.6 · χ² 94 / p 1e-22 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Contusion | 424 | 9.2 8.4–10.1ROR 9.6 · χ² 3,088 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 56% (drug 35%) · 87% consumer | no trial data cached |
| Fatigue (tiredness) | 331 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.012 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.6 · 80% consumer | no trial data cached |
| Off label use (used outside approved label) | 322 | 0.8 0.7–0.9ROR 0.8 · χ² 23 / p 9e-7 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Nausea | 307 | 0.8 0.7–0.9ROR 0.8 · χ² 14 / p 7e-5 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
| Dizziness | 301 | 1.3 1.1–1.4ROR 1.3 · χ² 16 / p 4e-5 | 1.3 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 · 76% consumer | no trial data cached |
| Thrombosis in device | 284 | 194.9 172.8–219.8ROR 200.5 · χ² 49,849 / p <1e-300 | 175.9 EB05 159.4 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=283 | no trial data cached |
| Epistaxis (nosebleed) | 252 | 7.0 6.2–7.9ROR 7.2 · χ² 1,290 / p 8e-283 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 82% consumer | no trial data cached |
| Headache | 246 | 0.8 0.7–0.9ROR 0.8 · χ² 10 / p 6e-4 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 · 72% consumer | no trial data cached |
| Asthenia (weakness) | 228 | 1.3 1.1–1.4ROR 1.3 · χ² 12 / p 3e-4 | 1.3 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 0.8 · 75% consumer | no trial data cached |
| Fall | 220 | 1.4 1.2–1.6ROR 1.4 · χ² 22 / p 1e-6 | 1.4 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Vessel puncture site haemorrhage — n=26, PRR 243.1
- Thrombosis in device — n=284, PRR 194.9
- Puncture site haemorrhage — n=33, PRR 101.8
- Vascular pseudoaneurysm — n=43, PRR 52.4
- Non-cardiac chest pain — n=24, PRR 15.8
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, gastrointestinal haemorrhage, chest pain, haemorrhage, dyspnoea, contusion. 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, 1,010 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.