Drug · FAERS side-effect profile with label screen
Bayer Aspirin Extra Strength side effects: what 3,949 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
3,949 reports · 60% serious · 306 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves headache pain and fever of colds muscle pain menstrual pain toothache minor pain of arthritis
FDA label, Indications and Usage
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 11Lab value / disease marker 1No label text to screen 28
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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 182 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 |
|---|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | 63 | 19.9 15.6–25.4ROR 20.2 · χ² 1,108 / p 3e-243 | 19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 79% consumer | no trial data cached |
| Gastric haemorrhage | 34 | 15.6 11.2–21.8ROR 15.8 · χ² 450 / p 4e-100 | 15.3 EB05 11.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · 88% consumer | no trial data cached |
| Internal haemorrhage | 33 | 15.3 10.9–21.6ROR 15.5 · χ² 427 / p 3e-95 | 15.0 EB05 11.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 | no trial data cached |
| Gastrointestinal haemorrhage | 226 | 14.3 12.6–16.2ROR 15.1 · χ² 2,787 / p <1e-300 | 14.2 EB05 12.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · 77% consumer | no trial data cached |
| Incorrect drug administration duration | 67 | 12.5 9.9–15.9ROR 12.7 · χ² 697 / p 9e-154 | 12.3 EB05 9.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 · 98% consumer | no trial data cached |
| Rectal haemorrhage | 68 | 8.4 6.6–10.6ROR 8.5 · χ² 435 / p 6e-97 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 78% consumer | no trial data cached |
| Gastric ulcer | 30 | 8.4 5.9–12.0ROR 8.4 · χ² 188 / p 6e-43 | 7.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 83% consumer | no trial data cached |
| Product prescribing issue | 26 | 6.8 4.6–10.0ROR 6.8 · χ² 123 / p 8e-29 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 96% consumer | no trial data cached |
| Expired product administered | 40 | 6.4 4.7–8.7ROR 6.5 · χ² 177 / p 1e-40 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=7 · 95% consumer | no trial data cached |
| Increased tendency to bruise | 11 | 6.3 3.5–11.4ROR 6.4 · χ² 44 / p 1e-11 | 5.1 EB05 3.1 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Product use complaint | 18 | 6.2 3.9–9.8ROR 6.2 · χ² 73 / p 7e-18 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| End stage renal disease | 21 | 6.1 4.0–9.3ROR 6.1 · χ² 84 / p 3e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Hair colour changes | 14 | 5.9 3.5–10.0ROR 5.9 · χ² 52 / p 2e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product use issue | 208 | 5.9 5.2–6.7ROR 6.2 · χ² 851 / p 2e-187 | 5.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Hiatus hernia | 14 | 5.7 3.4–9.7ROR 5.8 · χ² 50 / p 7e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Epistaxis (nosebleed) | 79 | 5.6 4.5–7.0ROR 5.7 · χ² 295 / p 2e-66 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 79% consumer | no trial data cached |
| Drug administration error | 32 | 5.5 3.9–7.7ROR 5.5 · χ² 112 / p 2e-26 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 · 87% consumer | no trial data cached |
| Post procedural haemorrhage | 12 | 5.5 3.1–9.6ROR 5.5 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Haematuria (blood in urine) | 35 | 5.4 3.9–7.5ROR 5.5 · χ² 122 / p 1e-28 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · ♀ 37% (drug 58%) · 71% consumer | no trial data cached |
| Body height decreased | 11 | 5.4 3.0–9.8ROR 5.4 · χ² 35 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Ulcer | 16 | 5.3 3.3–8.7ROR 5.4 · χ² 52 / p 3e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Haemorrhage intracranial | 15 | 5.3 3.2–8.8ROR 5.3 · χ² 48 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Drug hypersensitivity | 194 | 5.3 4.6–6.1ROR 5.5 · χ² 680 / p 4e-150 | 5.2 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 78% (drug 58%) · 82% consumer | no trial data cached |
| Madarosis | 11 | 5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Incorrect product administration duration | 19 | 5.0 3.2–7.8ROR 5.0 · χ² 56 / p 3e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Therapeutic response unexpected | 42 | 5.0 3.7–6.7ROR 5.0 · χ² 129 / p 4e-30 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 95% consumer | no trial data cached |
| Choking | 18 | 4.9 3.1–7.8ROR 4.9 · χ² 52 / p 2e-13 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Chronic kidney disease | 70 | 4.9 3.8–6.1ROR 4.9 · χ² 211 / p 4e-48 | 4.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Subdural haematoma | 13 | 4.8 2.8–8.3ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Hair texture abnormal | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 32 / p 9e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product use in unapproved indication | 214 | 4.7 4.1–5.3ROR 4.9 · χ² 617 / p 2e-136 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 89% consumer | no trial data cached |
| Blood urine present | 16 | 4.5 2.7–7.3ROR 4.5 · χ² 40 / p 2e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
| Macular degeneration | 10 | 4.5 2.4–8.3ROR 4.5 · χ² 23 / p 6e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Hyperlipidaemia | 10 | 4.4 2.4–8.2ROR 4.4 · χ² 23 / p 7e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Eye haemorrhage | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Drug prescribing error | 16 | 4.4 2.7–7.1ROR 4.4 · χ² 38 / p 3e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Sneezing | 18 | 4.3 2.7–6.8ROR 4.3 · χ² 42 / p 5e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial data cached |
| Haemorrhage | 83 | 4.2 3.4–5.2ROR 4.3 · χ² 201 / p 5e-46 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 83% consumer | no trial data cached |
| Haemoptysis | 22 | 4.2 2.8–6.3ROR 4.2 · χ² 50 / p 7e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 76% consumer | no trial data cached |
| Faeces discoloured | 17 | 4.2 2.6–6.7ROR 4.2 · χ² 38 / p 4e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | 226 | 14.3 12.6–16.2ROR 15.1 · χ² 2,787 / p <1e-300 | 14.2 EB05 12.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · 77% consumer | no trial data cached |
| Product use in unapproved indication | 214 | 4.7 4.1–5.3ROR 4.9 · χ² 617 / p 2e-136 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 89% consumer | no trial data cached |
| Product use issue | 208 | 5.9 5.2–6.7ROR 6.2 · χ² 851 / p 2e-187 | 5.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Drug hypersensitivity | 194 | 5.3 4.6–6.1ROR 5.5 · χ² 680 / p 4e-150 | 5.2 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 78% (drug 58%) · 82% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 107 | 3.7 3.1–4.5ROR 3.8 · χ² 213 / p 2e-48 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 · ♀ 35% (drug 58%) | no trial data cached |
| Myocardial infarction (heart attack) | 100 | 3.0 2.5–3.7ROR 3.1 · χ² 134 / p 2e-31 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · ♀ 36% (drug 58%) · 82% consumer | no trial data cached |
| Incorrect dose administered | 87 | 2.1 1.7–2.5ROR 2.1 · χ² 47 / p 5e-12 | 2.0 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.1 · 92% consumer | no trial data cached |
| Haemorrhage | 83 | 4.2 3.4–5.2ROR 4.3 · χ² 201 / p 5e-46 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 83% consumer | no trial data cached |
| Cerebrovascular accident (stroke) | 79 | 2.5 2.0–3.1ROR 2.5 · χ² 68 / p 8e-17 | 2.4 EB05 2.0 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · 81% consumer | no trial data cached |
| Epistaxis (nosebleed) | 79 | 5.6 4.5–7.0ROR 5.7 · χ² 295 / p 2e-66 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 79% consumer | no trial data cached |
| Wrong technique in product usage process | 78 | 2.1 1.6–2.6ROR 2.1 · χ² 41 / p 6e-11 | 2.0 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.5 · 95% consumer | no trial data cached |
| Chronic kidney disease | 70 | 4.9 3.8–6.1ROR 4.9 · χ² 211 / p 4e-48 | 4.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Rectal haemorrhage | 68 | 8.4 6.6–10.6ROR 8.5 · χ² 435 / p 6e-97 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 78% consumer | no trial data cached |
| Incorrect drug administration duration | 67 | 12.5 9.9–15.9ROR 12.7 · χ² 697 / p 9e-154 | 12.3 EB05 9.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 · 98% consumer | no trial data cached |
| Intentional product misuse | 63 | 3.9 3.0–4.9ROR 3.9 · χ² 131 / p 1e-30 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 77% consumer | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Bayer Aspirin Extra Strength?
In FDA FAERS, the most frequently co-reported reaction terms for Bayer Aspirin Extra Strength are gastrointestinal haemorrhage, drug hypersensitivity, acute kidney injury, myocardial infarction, haemorrhage, cerebrovascular accident. 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 Bayer Aspirin Extra Strength have an FDA boxed warning?
No. The FDA label retrieved for Bayer Aspirin Extra Strength has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bayer Aspirin Extra Strength 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 0ae64cdb-4ea0-23af-e054-00144ff88e88, effective 20251204; matched on
openfda.generic_name.exact:"BAYER ASPIRIN EXTRA STRENGTH") - 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, 222 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.