Drug · FAERS side-effect profile with label screen

Aspirin and Caffeine side effects: what 194 FDA adverse event reports show

Aspirin,Caffeine · 7 reaction terms · 197 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Aspirin (Cardiaspirin Protect)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

194 reports · 71% serious · 17 with death outcome · 73% 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

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 6 strongest signals

Lab value / disease marker 1Not in label — unassessed 5

What the badges mean

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. 1 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
Blood calcium decreased	32	307.4 223.9–422.1ROR 367.9 · χ² 9,447 / p <1e-300	259.1 EB05 192.2 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious PRR 310.4 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Orthostatic hypotension (dizziness on standing)	32	198.6 144.6–272.6ROR 237.6 · χ² 6,088 / p <1e-300	177.4 EB05 131.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 182.5 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Sedation	32	132.8 96.8–182.3ROR 158.9 · χ² 4,056 / p <1e-300	123.1 EB05 91.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 148.0 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Depressed level of consciousness	32	87.7 63.9–120.4ROR 104.8 · χ² 2,659 / p <1e-300	83.4 EB05 61.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 72.8 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Cognitive disorder	33	76.7 56.2–104.7ROR 92.2 · χ² 2,395 / p <1e-300	73.5 EB05 54.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 87.0 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Mobility decreased	33	49.8 36.5–68.0ROR 59.8 · χ² 1,535 / p <1e-300	48.5 EB05 36.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 57.7 · ♀ 100% (drug 73%) · 91% clinician	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
Mobility decreased	33	49.8 36.5–68.0ROR 59.8 · χ² 1,535 / p <1e-300	48.5 EB05 36.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 57.7 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Cognitive disorder	33	76.7 56.2–104.7ROR 92.2 · χ² 2,395 / p <1e-300	73.5 EB05 54.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 87.0 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Depressed level of consciousness	32	87.7 63.9–120.4ROR 104.8 · χ² 2,659 / p <1e-300	83.4 EB05 61.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 72.8 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Sedation	32	132.8 96.8–182.3ROR 158.9 · χ² 4,056 / p <1e-300	123.1 EB05 91.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 148.0 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Orthostatic hypotension (dizziness on standing)	32	198.6 144.6–272.6ROR 237.6 · χ² 6,088 / p <1e-300	177.4 EB05 131.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 182.5 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Blood calcium decreased	32	307.4 223.9–422.1ROR 367.9 · χ² 9,447 / p <1e-300	259.1 EB05 192.2 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious PRR 310.4 · ♀ 100% (drug 73%) · 91% clinician	no trial data cached
Gastric haemorrhage	3	28.0 9.1–86.0ROR 28.4 · χ² 53 / p 1e-13	18.0 EB05 3.6 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious PRR 23.5	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.

Orthostatic hypotension — n=32, PRR 198.6
Sedation — n=32, PRR 132.8
Depressed level of consciousness — n=32, PRR 87.7
Cognitive disorder — n=33, PRR 76.7
Mobility decreased — n=33, PRR 49.8

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 Aspirin and Caffeine?

In FDA FAERS, the most frequently co-reported reaction terms for Aspirin and Caffeine are mobility decreased, cognitive disorder, depressed level of consciousness, sedation, orthostatic hypotension, blood calcium decreased. 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 and Caffeine have an FDA boxed warning?

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

Do FAERS signals prove that Aspirin and Caffeine 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")
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, 7 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.