Drug · FAERS side-effect profile with label screen
Aspirin side effects: what 533,828 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Cardiaspirin Protect
openFDA label
Who reports
533,828 reports · 71% serious · 48,985 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ftemporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.
FDA label, Indications and Usage
What it is
Acetylsalicylic acid is a member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group.
PubChem CID 2244 (ChEBI)
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 38
What the badges mean
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,129 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease-mineral and bone disorder | 349 | 18.5 16.2–21.0ROR 18.5 · calibrated p 0.003 ✓ | 12.7 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other NSAIDs: PRR 17.0 (15.1–19.2) | Not in label — unassessed | serious n=349 · ♀ 0% (drug 49%) | not reported in cached trials |
| Nephrogenic anaemia | 1,442 | 17.2 16.1–18.3ROR 17.2 · calibrated p 0.004 ✓ | 12.1 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other NSAIDs: PRR 14.9 (14.1–15.8) | Not in label — unassessed | serious n=1,441 | not reported in cached trials |
| Hyperparathyroidism secondary | 760 | 16.5 15.1–18.0ROR 16.5 · calibrated p 0.005 ✓ | 11.8 EB05 11.1 · IC025 +3.4 3/3 methods agree vs other NSAIDs: PRR 15.1 (14.0–16.4) | Not in label — unassessed | serious n=759 | NCT01776424: 1/9,134 (0.0%) on Aspirin (serious AE) |
| Vascular stent thrombosis | 590 | 15.7 14.3–17.3ROR 15.7 · calibrated p 0.006 ✓ | 11.4 EB05 10.6 · IC025 +3.4 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=589 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Diverticulum intestinal haemorrhagic | 489 | 10.6 9.6–11.7ROR 10.6 · calibrated p 0.027 ✓ | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=488 | NCT01776424: 1/9,134 (0.0%) on Aspirin (serious AE) |
| Coronary artery stenosis | 1,069 | 10.3 9.6–11.0ROR 10.3 · calibrated p 0.029 ✓ | 8.3 EB05 7.9 · IC025 +2.9 3/3 methods agree vs other NSAIDs: PRR 250.1 (215.3–290.4) | Not in label — unassessed | serious n=1,062 | not reported in cached trials |
| Angina unstable | 1,372 | 10.1 9.6–10.8ROR 10.2 · calibrated p 0.030 ✓ | 8.2 EB05 7.8 · IC025 +2.9 3/3 methods agree vs other NSAIDs: PRR 154.8 (138.9–172.5) | Not in label — unassessed | serious n=1,365 | not reported in cached trials |
| Haemorrhagic anaemia | 912 | 9.9 9.2–10.6ROR 9.9 · calibrated p 0.034 ✓ | 8.0 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other NSAIDs: PRR 223.2 (191.3–260.5) | Not in label — unassessed | serious n=912 | not reported in cached trials |
| Carotid artery stenosis | 694 | 9.5 8.7–10.3ROR 9.5 · calibrated p 0.039 ✓ | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree vs other NSAIDs: PRR 329.6 (267.3–406.3) | Not in label — unassessed | serious n=690 | NCT01776424: 2/9,107 (0.0%) on Aspirin; 2/9,109 (0.0%) control (serious AE) |
| Lower gastrointestinal haemorrhage | 1,457 | 9.4 8.8–9.9ROR 9.4 · calibrated p 0.040 ✓ | 7.7 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other NSAIDs: PRR 60.4 (55.9–65.2) | Not in label — unassessed | serious PRR 6.2 | NCT01776424: 1/9,107 (0.0%) on Aspirin; 2/9,109 (0.0%) control (serious AE) |
| Thrombosis in device | 646 | 9.3 8.5–10.1ROR 9.3 · calibrated p 0.041 ✓ | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=642 · 100% clinician | not reported in cached trials |
| Coronary artery disease | 5,917 | 9.2 9.0–9.5ROR 9.3 · calibrated p 0.041 ✓ | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other NSAIDs: PRR 51.9 (50.1–53.7) | Not in label — unassessed | serious PRR 6.2 | NCT01776424: 1/9,134 (0.0%) on Aspirin; 1/9,109 (0.0%) control (serious AE) |
| Ischaemic cardiomyopathy | 598 | 9.2 8.4–10.0ROR 9.2 · calibrated p 0.043 ✓ | 7.5 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other NSAIDs: PRR 835.2 (591.3–1,179.7) | Not in label — unassessed | serious n=599 · ♀ 0% (drug 49%) | not reported in cached trials |
| Rebound acid hypersecretion | 581 | 9.0 8.2–9.8ROR 9.0 · calibrated p 0.047 ✓ | 7.4 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other NSAIDs: PRR 11.9 (10.9–13.0) | Not in label — unassessed | serious n=581 | not reported in cached trials |
| Aortic valve stenosis | 338 | 8.9 7.9–10.1ROR 8.9 · calibrated p 0.048 ✓ | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=338 · ♀ 100% (drug 49%) · 100% clinician | not reported in cached trials |
| Upper gastrointestinal haemorrhage | 3,153 | 8.8 8.5–9.2ROR 8.9 · calibrated p 0.048 ✓ | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other NSAIDs: PRR 20.7 (19.9–21.5) | Not in label — unassessed | serious PRR 5.9 | NCT01776424: 1/9,107 (0.0%) on Aspirin; 2/9,109 (0.0%) control (serious AE) |
| Coronary arterial stent insertion | 905 | 8.3 7.8–9.0ROR 8.4 · calibrated p 0.058 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=898 | not reported in cached trials |
| Diastolic dysfunction | 550 | 8.3 7.5–9.1ROR 8.3 · calibrated p 0.061 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree vs other NSAIDs: PRR 2,009.1 (1,159.3–3,481.8) | Not in label — unassessed | serious n=544 · 100% clinician | not reported in cached trials |
| Coronary artery occlusion | 2,386 | 8.0 7.7–8.4ROR 8.1 · calibrated p 0.065 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other NSAIDs: PRR 69.9 (65.7–74.4) | Not in label — unassessed | serious PRR 5.5 | not reported in cached trials |
| Essential hypertension | 443 | 7.9 7.1–8.8ROR 7.9 · calibrated p 0.069 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other NSAIDs: PRR 1,107.2 (699.7–1,752.2) | Not in label — unassessed | serious n=413 | not reported in cached trials |
| Coronary artery thrombosis | 343 | 7.8 7.0–8.8ROR 7.8 · calibrated p 0.072 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=341 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Retroperitoneal haemorrhage | 412 | 7.7 6.9–8.5ROR 7.7 · calibrated p 0.076 | 6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=410 · 100% clinician | not reported in cached trials |
| Gastrointestinal haemorrhage | 13,582 | 7.4 7.3–7.5ROR 7.5 · calibrated p 0.079 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other NSAIDs: PRR 36.2 (35.5–36.9) | Not in label — unassessed | age-adj. PRR 5.4 · serious PRR 5.1 | NCT01776424: 1/9,107 (0.0%) on Aspirin; 2/9,109 (0.0%) control (serious AE) |
| Labelled drug-drug interaction medication error | 1,431 | 7.3 6.9–7.7ROR 7.3 · calibrated p 0.086 | 6.3 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other NSAIDs: PRR 53.6 (49.7–57.7) | Reporting / coding artifact | serious PRR 5.9 | not reported in cached trials |
| Acute myocardial infarction | 4,747 | 7.3 7.1–7.5ROR 7.4 · calibrated p 0.085 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other NSAIDs: PRR 56.0 (53.8–58.3) | Not in label — unassessed | serious PRR 5.1 | NCT01776424: 1/9,134 (0.0%) on Aspirin; 1/9,107 (0.0%) control (serious AE) |
| Duodenal ulcer haemorrhage | 443 | 7.0 6.3–7.7ROR 7.0 · calibrated p 0.100 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 14.6 (13.1–16.2) | Not in label — unassessed | serious n=442 · ♀ 0% (drug 49%) | NCT01776424: 1/9,134 (0.0%) on Aspirin (serious AE) |
| Blood loss anaemia | 341 | 6.9 6.2–7.8ROR 6.9 · calibrated p 0.103 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 578.3 (393.5–850.0) | Not in label — unassessed | serious n=337 · ♀ 0% (drug 49%) | not reported in cached trials |
| Coronary artery bypass | 860 | 6.7 6.2–7.2ROR 6.7 · calibrated p 0.112 | 5.8 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=859 | not reported in cached trials |
| Carotid artery occlusion | 537 | 6.6 6.0–7.2ROR 6.6 · calibrated p 0.117 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 31.2 (28.0–34.8) | Not in label — unassessed | serious n=529 | not reported in cached trials |
| Gastric ulcer haemorrhage | 819 | 6.6 6.1–7.1ROR 6.6 · calibrated p 0.117 | 5.7 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 15.9 (14.7–17.2) | Not in label — unassessed | serious n=814 | NCT01776424: 1/9,134 (0.0%) on Aspirin; 1/9,109 (0.0%) control (serious AE) |
| Ventricular hypertrophy | 362 | 6.4 5.7–7.1ROR 6.4 · calibrated p 0.128 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=359 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Arteriosclerosis coronary artery | 940 | 6.4 5.9–6.8ROR 6.4 · calibrated p 0.129 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 53.8 (49.1–59.1) | Not in label — unassessed | serious n=929 | not reported in cached trials |
| Orthopnoea | 448 | 6.3 5.7–6.9ROR 6.3 · calibrated p 0.135 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other NSAIDs: PRR 607.9 (431.0–857.2) | Not in label — unassessed | serious n=431 | not reported in cached trials |
| Mitral valve incompetence | 1,587 | 6.2 5.9–6.6ROR 6.3 · calibrated p 0.134 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 33.9 (31.8–36.1) | Not in label — unassessed | age-adj. PRR 5.2 · serious PRR 4.5 | not reported in cached trials |
| End stage renal disease | 2,557 | 6.2 5.9–6.4ROR 6.2 · calibrated p 0.138 | 5.4 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other NSAIDs: PRR 12.0 (11.5–12.5) | Not in label — unassessed | serious PRR 4.4 | NCT01776424: 1/9,107 (0.0%) control (serious AE) |
| Haemorrhagic stroke | 1,089 | 6.2 5.8–6.6ROR 6.2 · calibrated p 0.140 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree vs other NSAIDs: PRR 49.8 (45.8–54.1) | Not in label — unassessed | serious PRR 4.4 | NCT00000479: 24/9,966 (0.2%) on Aspirin; 21/9,971 (0.2%) control (serious AE) |
| Radiculopathy | 364 | 6.1 5.5–6.9ROR 6.1 · calibrated p 0.142 | 5.4 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other NSAIDs: PRR 37.2 (32.4–42.6) | Not in label — unassessed | serious n=360 · ♀ 100% (drug 49%) · 100% clinician | NCT01776424: 1/9,134 (0.0%) on Aspirin (serious AE) |
| Aortic stenosis | 479 | 6.1 5.5–6.7ROR 6.1 · calibrated p 0.144 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree vs other NSAIDs: PRR 105.8 (90.1–124.2) | Not in label — unassessed | serious n=472 | NCT01776424: 1/9,107 (0.0%) control (serious AE) |
| Brain natriuretic peptide increased | 417 | 6.0 5.4–6.6ROR 6.0 · calibrated p 0.151 | 5.3 EB05 4.9 · IC025 +2.2 3/3 methods agree vs other NSAIDs: PRR 33.3 (29.4–37.8) | Lab value / disease marker | serious n=408 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Benign prostatic hyperplasia | 691 | 5.9 5.4–6.4ROR 5.9 · calibrated p 0.157 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other NSAIDs: PRR 47.0 (42.4–52.2) | Not in label — unassessed | serious n=671 · ♀ 0% (drug 49%) | NCT01776424: 1/12,903 (0.0%) on Aspirin; 1/9,109 (0.0%) control (serious AE) |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Gi bleeding | 24,021 | 5.85.7–5.9 | signal |
| Myocardial infarction | 19,661 | 4.14.0–4.1 | signal |
| Heart failure | 13,593 | 3.13.1–3.2 | signal |
| Stroke | 17,579 | 2.92.9–2.9 | signal |
| Rhabdomyolysis / myopathy | 5,535 | 2.82.7–2.9 | signal |
| Arrhythmia / qt | 12,373 | 2.62.6–2.7 | signal |
| Anaemia | 19,095 | 2.62.6–2.6 | signal |
| Kidney injury | 28,830 | 2.62.5–2.6 | signal |
| Hyponatraemia | 4,535 | 2.32.2–2.4 | signal |
| Fall / fracture | 20,448 | 2.22.1–2.2 | signal |
| Hypoglycaemia | 4,766 | 2.01.9–2.1 | raised |
| Venous thromboembolism | 10,084 | 1.91.8–1.9 | raised |
| Serious infection | 33,912 | 1.81.7–1.8 | raised |
| Hyperglycaemia / diabetes | 14,869 | 1.71.7–1.7 | raised |
| Thrombocytopenia | 8,976 | 1.61.6–1.7 | raised |
| Pancreatitis | 3,090 | 1.51.5–1.6 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Aspirin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (15 of 40 signal terms matched).
- NCT00000479 — Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of (N=39876, PHASE3; 5 AE terms posted; arms: Aspirin Only; Vitamin E Only; Aspirin + Vitamin E; Both Placebos)
- NCT01776424 — Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (N=27395, PHASE3; 904 AE terms posted; arms: Rivaroxaban 2.5mg + Aspirin 100mg; Rivaroxaban 5mg + Aspirin Placebo; Rivaroxaban Placebo + Aspirin 100mg; LTOLE Rivaroxaban Rivaroxaban 2.5mg + As)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 33,177 | 1.7 1.7–1.7ROR 1.8 · calibrated p 0.802 | 1.7 EB05 1.7 · IC025 +0.7 vs other NSAIDs: PRR 11.2 (11.2–11.2) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.6 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 28,124 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.975 | 2.0 EB05 1.9 · IC025 +0.9 vs other NSAIDs: PRR 13.7 (13.6–13.7) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.8 | NCT01776424: 4/9,107 (0.0%) on Aspirin; 5/9,109 (0.1%) control (serious AE) |
| Diarrhoea (diarrhea) | 27,521 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.799 | 1.7 EB05 1.7 · IC025 +0.7 vs other NSAIDs: PRR 13.4 (13.4–13.5) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.5 | NCT01776424: 1/12,903 (0.0%) on Aspirin; 5/9,109 (0.1%) control (serious AE) |
| Nausea | 27,461 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.575 | 1.4 EB05 1.4 · IC025 +0.4 vs other NSAIDs: PRR 10.0 (9.9–10.0) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT01776424: 1/12,903 (0.0%) on Aspirin (serious AE) |
| Dizziness | 23,152 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.891 | 1.8 EB05 1.8 · IC025 +0.8 vs other NSAIDs: PRR 13.3 (13.2–13.4) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.8 | NCT01776424: 1/12,903 (0.0%) on Aspirin; 2/9,109 (0.0%) control (serious AE) |
| Drug ineffective (drug did not work) | 22,502 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.106 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other NSAIDs: PRR 5.9 (5.8–5.9) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.9 | not reported in cached trials |
| Headache | 20,319 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.504 | 1.3 EB05 1.3 · IC025 +0.3 vs other NSAIDs: PRR 8.2 (8.2–8.3) | Likely indication confounding term in indications | age-adj. PRR 1.3 · serious PRR 1.4 | NCT01776424: 3/9,134 (0.0%) on Aspirin; 3/9,109 (0.0%) control (serious AE) |
| Off label use (used outside approved label) | 19,688 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.233 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other NSAIDs: PRR 9.3 (9.2–9.4) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 0.9 | not reported in cached trials |
| Asthenia (weakness) | 19,497 | 2.1 2.1–2.1ROR 2.1 · calibrated p 0.985 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other NSAIDs: PRR 14.6 (14.5–14.8) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.8 | NCT01776424: 1/12,903 (0.0%) on Aspirin; 3/9,109 (0.0%) control (serious AE) |
| Fall | 19,221 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.858 | 2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree vs other NSAIDs: PRR 18.3 (18.1–18.5) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 2.0 | NCT01776424: 2/9,107 (0.0%) control (serious AE) |
| Pain | 18,658 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.442 | 1.2 EB05 1.2 · IC025 +0.2 vs other NSAIDs: PRR 6.1 (6.0–6.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 1.4 · serious PRR 1.1 | NCT01776424: 1/12,903 (0.0%) on Aspirin; 4/9,109 (0.0%) control (serious AE) |
| Pneumonia (lung infection) | 16,494 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.993 | 2.0 EB05 2.0 · IC025 +1.0 vs other NSAIDs: PRR 15.6 (15.4–15.8) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.6 | NCT01776424: 17/12,903 (0.1%) on Aspirin; 21/9,109 (0.2%) control (serious AE) |
| Vomiting | 16,402 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.574 | 1.4 EB05 1.4 · IC025 +0.4 vs other NSAIDs: PRR 8.3 (8.2–8.4) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.4 | NCT01776424: 2/9,107 (0.0%) on Aspirin; 1/9,109 (0.0%) control (serious AE) |
| Death | 15,407 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.124 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other NSAIDs: PRR 21.1 (20.8–21.4) | Outcome field, not a reaction | age-adj. PRR 0.6 · serious PRR 0.6 | NCT01776424: 5/12,903 (0.0%) on Aspirin; 3/9,109 (0.0%) control (serious AE) |
| Myocardial infarction (heart attack) | 15,163 | 3.6 3.6–3.7ROR 3.7 · calibrated p 0.441 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other NSAIDs: PRR 36.5 (35.8–37.1) | Not in label — unassessed | age-adj. PRR 3.6 · serious PRR 2.7 | NCT01776424: 1/9,134 (0.0%) on Aspirin; 1/9,107 (0.0%) control (serious AE) |
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.
- Chronic kidney disease-mineral and bone disorder — n=349, PRR 18.5
- Nephrogenic anaemia — n=1,442, PRR 17.2
- Hyperparathyroidism secondary — n=760, PRR 16.5 (also seen in trial arm)
- Vascular stent thrombosis — n=590, PRR 15.7
- Diverticulum intestinal haemorrhagic — n=489, PRR 10.6 (also seen in trial arm)
- Coronary artery stenosis — n=1,069, PRR 10.3
- Angina unstable — n=1,372, PRR 10.1
- Haemorrhagic anaemia — n=912, PRR 9.9
- Carotid artery stenosis — n=694, PRR 9.5 (also seen in trial arm)
- Lower gastrointestinal haemorrhage — n=1,457, PRR 9.4 (also seen in trial arm)
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 Aspirin?
In FDA FAERS, the most frequently co-reported reaction terms for Aspirin are fatigue, dyspnoea, diarrhoea, nausea, dizziness, headache. 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 Aspirin have an FDA boxed warning?
No. The FDA label retrieved for Aspirin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aspirin 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 03774690-662b-1c30-e063-6294a90a3488, effective 20260819; matched on
openfda.generic_name.exact:"ASPIRIN") - PubChem CID 2244 description (ChEBI)
- 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, 1,169 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 - ClinicalTrials.gov API v2 (query
ASPIRIN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.