Clopidogrel vs Prasugrel: side effects in FDA adverse event reports
At a glance
| Clopidogrel | Prasugrel | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 197,000 | 10,097 |
| Serious | 81% | 75% |
| Death outcome | 21,779 | 857 |
| Boxed warning | Yes DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS The effectiveness of clopidogrel is dependent on its activation to an active metabolite by the cytochrome P450 (CY | Yes BLEEDING RISK • Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . • D |
Signals both drugs share
| Reaction | Clopidogrel | Prasugrel | Label screen (A / B) |
|---|---|---|---|
| Stent placement | 938 · PRR 13.9 | 83 · PRR 21.6 | Not in label — unassessed / Labeled adverse reaction |
| Thrombotic thrombocytopenic purpura | 456 · PRR 15.7 | 29 · PRR 17.2 | Labeled — boxed warning / Labeled adverse reaction |
| Retroperitoneal haemorrhage | 253 · PRR 12.0 | 53 · PRR 45.5 | Labeled adverse reaction / Labeled adverse reaction |
| Coronary artery thrombosis | 258 · PRR 15.4 | 27 · PRR 28.0 | Likely indication confounding / Labeled (related wording) |
| Diverticulum intestinal haemorrhagic | 249 · PRR 13.0 | 21 · PRR 19.4 | Labeled (related wording) / Labeled (related wording) |
| Retroperitoneal haematoma | 229 · PRR 12.3 | 16 · PRR 15.2 | Labeled (related wording) / Labeled (related wording) |
| Acute myocardial infarction | 3,083 · PRR 12.3 | 214 · PRR 15.1 | Likely indication confounding / Likely indication confounding |
| Coronary artery occlusion | 1,659 · PRR 14.4 | 121 · PRR 18.4 | Likely indication confounding / Likely indication confounding |
| Coronary arterial stent insertion | 936 · PRR 24.0 | 44 · PRR 18.2 | Likely indication confounding / Likely indication confounding |
| Angina unstable | 820 · PRR 15.1 | 67 · PRR 21.4 | Likely indication confounding / Likely indication confounding |
| Thrombosis in device | 544 · PRR 20.8 | 284 · PRR 194.9 | Not in label — unassessed / Not in label — unassessed |
| Vascular stent thrombosis | 642 · PRR 48.9 | 109 · PRR 117.6 | Not in label — unassessed / Likely indication confounding |
| Coronary artery stenosis | 700 · PRR 17.0 | 48 · PRR 19.9 | Likely indication confounding / Likely indication confounding |
| Vascular pseudoaneurysm | 291 · PRR 21.1 | 43 · PRR 52.4 | Not in label — unassessed / Not in label — unassessed |
| Coronary artery restenosis | 173 · PRR 42.7 | 54 · PRR 204.8 | Likely indication confounding / Likely indication confounding |
| Angioplasty | 184 · PRR 14.8 | 14 · PRR 19.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Clopidogrel
- Gastrointestinal haemorrhage — n=8,285, PRR 11.5 Labeled adverse reaction
- Upper gastrointestinal haemorrhage — n=1,605, PRR 11.1 Labeled (related wording)
- Ulcer haemorrhage — n=998, PRR 18.3 Labeled (related wording)
- Acute coronary syndrome — n=774, PRR 10.8 Labeled — boxed warning
- Blood loss anaemia — n=216, PRR 11.3 Labeled (related wording)
Labeled signals distinctive to Prasugrel
- Haemorrhage intracranial — n=173, PRR 24.2 Labeled (related wording)
- Thrombotic cerebral infarction — n=42, PRR 260.6 Labeled (related wording)
- Cardiac tamponade — n=35, PRR 15.4 Labeled (related wording)
- Pericardial haemorrhage — n=20, PRR 19.1 Labeled (related wording)
- Large intestinal haemorrhage — n=18, PRR 16.7 Labeled (related wording)
- Platelet aggregation inhibition — n=10, PRR 252.8 Labeled (related wording)
Common questions
Which has more reported side effects, Clopidogrel or Prasugrel?
Clopidogrel has 197,000 FAERS reports and Prasugrel 10,097. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (81% vs 75%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Clopidogrel and Prasugrel share?
Both drugs carry disproportionality signals for stent placement, thrombotic thrombocytopenic purpura, retroperitoneal haemorrhage, coronary artery thrombosis, diverticulum intestinal haemorrhagic. Shared signals often reflect a shared drug class or the condition both are used for.
Is Clopidogrel or Prasugrel safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.