Caffeine side effects: what 2,261 FDA adverse event reports show

Caffeine Citrate · Uplift Chewable · 223 reaction terms · 74,679 drug–reaction co-reports · data 2026-09-14

Drug class

Central Nervous System Stimulant, Methylxanthine

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Uplift Chewable

openFDA label

Who reports

2,261 reports · 97% serious · 1,172 with death outcome · 86% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

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 2Lab value / disease marker 3No label text to screen 35

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. 183 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
Helicobacter infection	834	827.0 780.7–876.1ROR 1,309.8 · χ² 630,602 / p <1e-300	745.5 EB05 704.0 · IC025 +8.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 474.1 · 95% clinician	no trial arm names this drug
Pemphigus	989	802.3 762.9–843.6ROR 1,425.3 · χ² 727,363 / p <1e-300	727.2 EB05 690.0 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 437.6 · 94% clinician	no trial arm names this drug
Hand deformity	928	708.6 672.3–746.8ROR 1,201.2 · χ² 608,294 / p <1e-300	648.9 EB05 614.6 · IC025 +8.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 423.0 · 93% clinician	no trial arm names this drug
Pericarditis	945	557.8 530.0–587.1ROR 957.7 · χ² 494,962 / p <1e-300	520.3 EB05 493.0 · IC025 +8.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 313.5 · 93% clinician	no trial arm names this drug
Folliculitis	574	546.0 507.3–587.6ROR 731.4 · χ² 294,285 / p <1e-300	506.5 EB05 472.7 · IC025 +8.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 358.2 · 97% clinician	no trial arm names this drug
Hypercholesterolaemia	494	505.2 466.0–547.6ROR 646.1 · χ² 235,184 / p <1e-300	470.0 EB05 436.2 · IC025 +8.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 301.0 · 95% clinician	no trial arm names this drug
Synovitis	860	464.2 439.5–490.4ROR 748.6 · χ² 378,223 / p <1e-300	437.6 EB05 413.6 · IC025 +8.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 273.7 · 93% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	948	410.8 390.7–432.0ROR 706.7 · χ² 370,927 / p <1e-300	390.1 EB05 369.7 · IC025 +8.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 336.7 · 93% clinician	no trial arm names this drug
Autoimmune disorder	319	319.8 288.3–354.8ROR 372.2 · χ² 97,694 / p <1e-300	303.4 EB05 276.5 · IC025 +7.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 195.5 · 94% clinician	no trial arm names this drug
Joint range of motion decreased	432	309.8 284.1–337.8ROR 382.8 · χ² 128,406 / p <1e-300	295.8 EB05 273.1 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 226.0 · 97% clinician	no trial arm names this drug
Wound	886	305.3 289.7–321.9ROR 501.5 · χ² 260,138 / p <1e-300	293.6 EB05 277.8 · IC025 +7.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 208.2 · 93% clinician	no trial arm names this drug
Liver injury	747	295.7 278.4–314.0ROR 441.1 · χ² 212,483 / p <1e-300	284.4 EB05 267.7 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 175.7 · 95% clinician	no trial arm names this drug
Wound infection	324	285.0 257.2–315.8ROR 332.5 · χ² 88,697 / p <1e-300	272.0 EB05 248.0 · IC025 +7.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 175.3 · 95% clinician	no trial arm names this drug
Bursitis	343	271.4 245.8–299.7ROR 319.8 · χ² 89,534 / p <1e-300	259.8 EB05 237.5 · IC025 +7.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 183.5 · 96% clinician	no trial arm names this drug
Fibromyalgia	679	266.8 250.2–284.5ROR 380.9 · χ² 174,646 / p <1e-300	257.4 EB05 241.5 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 201.4 · 94% clinician	no trial arm names this drug
Irritable bowel syndrome	540	240.5 223.2–259.2ROR 315.6 · χ² 125,388 / p <1e-300	232.4 EB05 216.4 · IC025 +7.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 176.0 · 97% clinician	no trial arm names this drug
Systemic lupus erythematosus	894	240.5 228.3–253.3ROR 397.1 · χ² 207,872 / p <1e-300	233.2 EB05 220.6 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 142.2 · 93% clinician	no trial arm names this drug
Hip arthroplasty	330	206.0 186.2–227.9ROR 241.1 · χ² 65,697 / p <1e-300	199.2 EB05 181.8 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 122.9 · 95% clinician	no trial arm names this drug
Pulmonary fibrosis	413	204.9 187.5–223.8ROR 250.4 · χ² 81,822 / p <1e-300	198.6 EB05 183.0 · IC025 +7.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 119.8 · 98% clinician	no trial arm names this drug
Type 2 diabetes mellitus	689	193.2 181.3–205.8ROR 277.4 · χ² 129,008 / p <1e-300	188.2 EB05 176.7 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 117.9 · 95% clinician	no trial arm names this drug
Foot deformity	225	191.9 169.3–217.6ROR 213.0 · χ² 41,692 / p <1e-300	185.1 EB05 165.6 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 129.3 · 93% clinician	no trial arm names this drug
Contraindicated product administered	610	191.4 178.7–205.1ROR 261.8 · χ² 113,172 / p <1e-300	186.5 EB05 174.4 · IC025 +7.2 3/3 methods agree	Reporting / coding artifact	serious PRR 138.2 · 93% clinician	no trial arm names this drug
Laryngitis	213	185.6 163.1–211.2ROR 204.8 · χ² 38,169 / p <1e-300	179.0 EB05 159.7 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=213 · 95% clinician	no trial arm names this drug
Psoriatic arthropathy	717	168.4 158.3–179.0ROR 246.1 · χ² 117,186 / p <1e-300	164.6 EB05 154.7 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 123.0 · 95% clinician	no trial arm names this drug
Impaired healing	576	165.6 154.2–177.8ROR 221.9 · χ² 92,541 / p <1e-300	161.8 EB05 151.0 · IC025 +7.0 3/3 methods agree	Reporting / coding artifact	serious PRR 116.4 · 97% clinician	no trial arm names this drug
Obesity	279	165.1 147.7–184.4ROR 188.2 · χ² 44,562 / p <1e-300	160.4 EB05 145.2 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 111.3 · 95% clinician	no trial arm names this drug
Red blood cell sedimentation rate increased	192	163.4 142.5–187.3ROR 178.4 · χ² 30,299 / p <1e-300	158.0 EB05 140.1 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious PRR 107.7 · 94% clinician	no trial arm names this drug
Sciatica	269	160.0 142.9–179.2ROR 181.5 · χ² 41,652 / p <1e-300	155.6 EB05 140.6 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 125.0 · 92% clinician	no trial arm names this drug
Arthropathy	909	153.6 146.0–161.7ROR 256.3 · χ² 135,780 / p <1e-300	150.6 EB05 142.6 · IC025 +7.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 109.0 · 93% clinician	no trial arm names this drug
Blood cholesterol increased	746	150.8 142.1–160.0ROR 224.5 · χ² 109,281 / p <1e-300	147.8 EB05 139.1 · IC025 +7.0 3/3 methods agree	Lab value / disease marker	serious PRR 133.1 · 94% clinician	no trial arm names this drug
Prescribed overdose	309	150.5 135.5–167.1ROR 174.2 · χ² 45,037 / p <1e-300	146.7 EB05 133.5 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 149.4 · 94% clinician	no trial arm names this drug
Lower limb fracture	294	145.0 130.2–161.5ROR 166.5 · χ² 41,290 / p <1e-300	141.5 EB05 128.4 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 92.8 · 93% clinician	no trial arm names this drug
Discomfort	900	139.8 132.8–147.1ROR 231.5 · χ² 122,350 / p <1e-300	137.3 EB05 129.9 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 143.2 · 93% clinician	no trial arm names this drug
Knee arthroplasty	307	138.6 124.8–153.9ROR 160.2 · χ² 41,217 / p <1e-300	135.4 EB05 123.2 · IC025 +6.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 84.1 · 95% clinician	no trial arm names this drug
Hepatic enzyme increased	953	131.9 125.6–138.5ROR 227.3 · χ² 122,319 / p <1e-300	129.7 EB05 122.9 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious PRR 111.3 · 93% clinician	no trial arm names this drug
Blister	758	127.2 120.0–134.9ROR 190.8 · χ² 93,729 / p <1e-300	125.1 EB05 117.8 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 122.7 · 95% clinician	no trial arm names this drug
Joint dislocation	140	125.0 106.3–146.9ROR 133.1 · χ² 16,871 / p <1e-300	121.3 EB05 105.3 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 82.1 · 93% clinician	no trial arm names this drug
Infusion related reaction (reaction during infusion)	869	123.6 117.3–130.3ROR 200.2 · χ² 104,512 / p <1e-300	121.7 EB05 115.0 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 91.0 · 93% clinician	no trial arm names this drug
Lower respiratory tract infection	596	123.6 115.3–132.5ROR 167.5 · χ² 71,547 / p <1e-300	121.5 EB05 113.5 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 76.3 · 96% clinician	no trial arm names this drug
Hepatic cirrhosis	243	122.2 108.4–137.7ROR 136.8 · χ² 28,724 / p <1e-300	119.5 EB05 107.4 · IC025 +6.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 72.2 · 94% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Caffeine (searched CAFFEINE).

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
Pemphigus	989	802.3 762.9–843.6ROR 1,425.3 · χ² 727,363 / p <1e-300	727.2 EB05 690.0 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 437.6 · 94% clinician	no trial arm names this drug
Hepatic enzyme increased	953	131.9 125.6–138.5ROR 227.3 · χ² 122,319 / p <1e-300	129.7 EB05 122.9 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious PRR 111.3 · 93% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	948	410.8 390.7–432.0ROR 706.7 · χ² 370,927 / p <1e-300	390.1 EB05 369.7 · IC025 +8.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 336.7 · 93% clinician	no trial arm names this drug
Pericarditis	945	557.8 530.0–587.1ROR 957.7 · χ² 494,962 / p <1e-300	520.3 EB05 493.0 · IC025 +8.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 313.5 · 93% clinician	no trial arm names this drug
Alopecia (hair loss)	937	44.4 42.2–46.6ROR 75.1 · χ² 39,863 / p <1e-300	44.1 EB05 41.8 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 55.8 · 93% clinician	no trial arm names this drug
Hand deformity	928	708.6 672.3–746.8ROR 1,201.2 · χ² 608,294 / p <1e-300	648.9 EB05 614.6 · IC025 +8.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 423.0 · 93% clinician	no trial arm names this drug
Joint swelling	926	71.8 68.3–75.5ROR 121.0 · χ² 64,479 / p <1e-300	71.2 EB05 67.4 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 72.7 · 94% clinician	no trial arm names this drug
Pain	915	13.8 13.1–14.5ROR 22.5 · χ² 11,172 / p <1e-300	13.8 EB05 13.0 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.9 · 92% clinician	no trial arm names this drug
Rheumatoid arthritis	914	75.6 71.9–79.5ROR 126.2 · χ² 66,997 / p <1e-300	74.9 EB05 70.9 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 54.2 · 93% clinician	no trial arm names this drug
Arthropathy	909	153.6 146.0–161.7ROR 256.3 · χ² 135,780 / p <1e-300	150.6 EB05 142.6 · IC025 +7.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 109.0 · 93% clinician	no trial arm names this drug
Discomfort	900	139.8 132.8–147.1ROR 231.5 · χ² 122,350 / p <1e-300	137.3 EB05 129.9 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 143.2 · 93% clinician	no trial arm names this drug
Fatigue (tiredness)	899	10.7 10.2–11.3ROR 17.2 · χ² 8,231 / p <1e-300	10.7 EB05 10.1 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.1 · 93% clinician	no trial arm names this drug
Systemic lupus erythematosus	894	240.5 228.3–253.3ROR 397.1 · χ² 207,872 / p <1e-300	233.2 EB05 220.6 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 142.2 · 93% clinician	no trial arm names this drug
Abdominal discomfort	889	49.6 47.1–52.2ROR 81.1 · χ² 42,383 / p <1e-300	49.3 EB05 46.6 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 65.5 · 93% clinician	no trial arm names this drug
Wound	886	305.3 289.7–321.9ROR 501.5 · χ² 260,138 / p <1e-300	293.6 EB05 277.8 · IC025 +7.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 208.2 · 93% clinician	no trial arm names this drug

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 Caffeine?

In FDA FAERS, the most frequently co-reported reaction terms for Caffeine are pemphigus, hepatic enzyme increased, glossodynia, pericarditis, alopecia, hand deformity. 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 Caffeine have an FDA boxed warning?

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

Do FAERS signals prove that 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 01e352a7-24f3-d380-e063-6394a90acc5e, effective 20250115; matched on openfda.generic_name.exact:"CAFFEINE")
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, 223 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 CAFFEINE, results-bearing studies sorted by enrollment)

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.