Aspirin Low Dose side effects: what 1,197 FDA adverse event reports show

Aspirin Low Dose · 18 reaction terms · 177 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,197 reports · 60% serious · 78 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief.

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 12 strongest signals

Reporting / coding artifact 3Lab value / disease marker 3No label text to screen 6

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. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Full blood count decreased	20	17.4 11.3–26.9ROR 17.7 · χ² 293 / p 6e-66	16.9 EB05 11.3 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 19.2 · ♀ 35% (drug 56%) · 100% clinician	no trial data cached
Blood count abnormal	9	10.3 5.3–19.7ROR 10.3 · χ² 66 / p 2e-16	8.0 EB05 4.1 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 6.1	no trial data cached
Plasma cell myeloma	22	9.9 6.5–14.9ROR 10.0 · χ² 167 / p 2e-38	8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.9 · 95% clinician	no trial data cached
Blood potassium increased	8	8.6 4.3–17.2ROR 8.7 · χ² 47 / p 4e-12	6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 8.0	no trial data cached
Musculoskeletal disorder	9	8.2 4.3–15.8ROR 8.3 · χ² 50 / p 7e-13	6.3 EB05 3.4 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.4	no trial data cached
Laboratory test abnormal	13	7.7 4.5–13.3ROR 7.8 · χ² 70 / p 4e-17	6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Coronary artery occlusion	6	7.6 3.4–16.9ROR 7.7 · χ² 28 / p 5e-8	5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.3	no trial data cached
Dialysis	5	6.2 2.6–14.8ROR 6.2 · χ² 17 / p 2e-5	4.2 EB05 2.0 · IC025 +0.5	No label text to screen label has no adverse-reaction text	serious PRR 6.2	no trial data cached
Rash generalised	8	5.3 2.7–10.6ROR 5.4 · χ² 24 / p 5e-7	4.2 EB05 2.3 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.6	no trial data cached
Product dose omission	17	4.5 2.8–7.2ROR 4.5 · χ² 43 / p 3e-11	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3	no trial data cached
Multiple sclerosis relapse	14	3.5 2.1–6.0ROR 3.6 · χ² 23 / p 7e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.4	no trial data cached
Drug dose omission	23	2.4 1.6–3.6ROR 2.4 · χ² 18 / p 1e-5	2.3 EB05 1.6 · IC025 +0.5	Reporting / coding artifact	serious PRR 2.6	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
Drug dose omission	23	2.4 1.6–3.6ROR 2.4 · χ² 18 / p 1e-5	2.3 EB05 1.6 · IC025 +0.5	Reporting / coding artifact	serious PRR 2.6	no trial data cached
Plasma cell myeloma	22	9.9 6.5–14.9ROR 10.0 · χ² 167 / p 2e-38	8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.9 · 95% clinician	no trial data cached
Full blood count decreased	20	17.4 11.3–26.9ROR 17.7 · χ² 293 / p 6e-66	16.9 EB05 11.3 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 19.2 · ♀ 35% (drug 56%) · 100% clinician	no trial data cached
Product dose omission	17	4.5 2.8–7.2ROR 4.5 · χ² 43 / p 3e-11	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3	no trial data cached
Multiple sclerosis relapse	14	3.5 2.1–6.0ROR 3.6 · χ² 23 / p 7e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.4	no trial data cached
Laboratory test abnormal	13	7.7 4.5–13.3ROR 7.8 · χ² 70 / p 4e-17	6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Musculoskeletal disorder	9	8.2 4.3–15.8ROR 8.3 · χ² 50 / p 7e-13	6.3 EB05 3.4 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.4	no trial data cached
Blood count abnormal	9	10.3 5.3–19.7ROR 10.3 · χ² 66 / p 2e-16	8.0 EB05 4.1 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 6.1	no trial data cached
Rash generalised	8	5.3 2.7–10.6ROR 5.4 · χ² 24 / p 5e-7	4.2 EB05 2.3 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.6	no trial data cached
Blood potassium increased	8	8.6 4.3–17.2ROR 8.7 · χ² 47 / p 4e-12	6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 8.0	no trial data cached
Multiple sclerosis	6	2.2 1.0–4.9ROR 2.2 · χ² 3 / p 0.048	2.0 EB05 1.0 · IC025 -0.4 PRR-only: not supported by EBGM or IC	No label text to screen label has no adverse-reaction text	serious PRR 2.6	no trial data cached
Coronary artery occlusion	6	7.6 3.4–16.9ROR 7.7 · χ² 28 / p 5e-8	5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.3	no trial data cached
Dialysis	5	6.2 2.6–14.8ROR 6.2 · χ² 17 / p 2e-5	4.2 EB05 2.0 · IC025 +0.5	No label text to screen label has no adverse-reaction text	serious PRR 6.2	no trial data cached
Pulmonary thrombosis	4	6.4 2.4–17.1ROR 6.4 · χ² 13 / p 1e-4	4.1 EB05 1.8 · IC025 +0.2	No label text to screen label has no adverse-reaction text	serious PRR 6.2	no trial data cached
Nerve compression	4	7.6 2.9–20.2ROR 7.6 · χ² 17 / p 2e-5	4.6 EB05 1.9 · IC025 +0.4	No label text to screen label has no adverse-reaction text	serious PRR 7.4	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 Aspirin Low Dose?

In FDA FAERS, the most frequently co-reported reaction terms for Aspirin Low Dose are plasma cell myeloma, full blood count decreased, multiple sclerosis relapse, musculoskeletal disorder, blood count abnormal, rash generalised. 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 Low Dose have an FDA boxed warning?

No. The FDA label retrieved for Aspirin Low Dose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Aspirin Low Dose 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 347edc8f-6391-b75e-e063-6394a90a1cf5, effective 20250506; matched on openfda.generic_name.exact:"ASPIRIN LOW DOSE")
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, field patient.drug.openfda.generic_name.exact, 18 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.