Drug · FAERS side-effect profile with label screen
Caffeine side effects: what 7,794 FDA adverse event reports show
Drug class
Central Nervous System Stimulant, Methylxanthine
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Uplift Chewable
openFDA label
Who reports
7,794 reports · 89% serious · 3,150 with death outcome · 65% 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 1No label text to screen 37
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, 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). 475 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 |
|---|---|---|---|---|---|---|
| Helicobacter infection | 948 | 276.1 259.2–294.0ROR 314.1 · calibrated p 6e-12 ✓ | 248.9 EB05 235.9 · IC025 +7.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.1 (2.9–3.4) | No label text to screen label has no adverse-reaction text | serious PRR 170.5 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Folliculitis | 878 | 250.1 234.2–267.0ROR 281.7 · calibrated p 2e-11 ✓ | 227.5 EB05 215.2 · IC025 +7.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.0 (3.6–4.5) | No label text to screen label has no adverse-reaction text | serious PRR 173.3 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Pemphigus | 960 | 225.3 211.7–239.7ROR 256.8 · calibrated p 4e-11 ✓ | 206.9 EB05 196.1 · IC025 +7.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.7 (2.5–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 134.5 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Autoimmune disorder | 711 | 216.0 200.8–232.4ROR 237.6 · calibrated p 9e-11 ✓ | 198.8 EB05 186.8 · IC025 +7.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.6 (4.1–5.1) | No label text to screen label has no adverse-reaction text | serious PRR 138.0 · ♀ 100% (drug 65%) · 90% clinician | no trial arm names this drug |
| Hand deformity | 963 | 213.9 201.1–227.5ROR 243.9 · calibrated p 7e-11 ✓ | 197.2 EB05 187.0 · IC025 +7.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.9 (2.6–3.2) | No label text to screen label has no adverse-reaction text | serious PRR 139.0 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Pericarditis | 963 | 165.1 155.3–175.5ROR 188.2 · calibrated p 7e-10 ✓ | 155.0 EB05 146.9 · IC025 +7.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.7 (2.5–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 101.2 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Bursitis | 600 | 140.8 130.1–152.4ROR 152.5 · calibrated p 4e-9 ✓ | 133.2 EB05 124.5 · IC025 +6.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.1 (3.6–4.7) | No label text to screen label has no adverse-reaction text | serious PRR 101.5 · ♀ 100% (drug 65%) · 96% clinician | no trial arm names this drug |
| Synovitis | 880 | 137.9 129.4–147.1ROR 155.4 · calibrated p 4e-9 ✓ | 130.8 EB05 123.7 · IC025 +6.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.8 (2.6–3.1) | No label text to screen label has no adverse-reaction text | serious PRR 88.6 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Glossodynia (burning tongue/mouth pain) | 909 | 114.0 107.1–121.4ROR 129.0 · calibrated p 2e-8 ✓ | 109.1 EB05 103.3 · IC025 +6.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.7) | No label text to screen label has no adverse-reaction text | serious PRR 102.1 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Joint range of motion decreased | 536 | 112.4 103.4–122.2ROR 120.6 · calibrated p 3e-8 ✓ | 107.5 EB05 100.0 · IC025 +6.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.3 (2.9–3.7) | No label text to screen label has no adverse-reaction text | serious PRR 88.6 · ♀ 100% (drug 65%) · 96% clinician | no trial arm names this drug |
| Sciatica | 602 | 106.2 98.1–114.8ROR 115.0 · calibrated p 4e-8 ✓ | 101.8 EB05 95.1 · IC025 +6.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.0 (3.5–4.5) | No label text to screen label has no adverse-reaction text | serious PRR 88.6 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Irritable bowel syndrome | 786 | 102.8 96.0–110.0ROR 114.2 · calibrated p 4e-8 ✓ | 98.7 EB05 93.1 · IC025 +6.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.8 (2.5–3.1) | No label text to screen label has no adverse-reaction text | serious PRR 81.0 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Lower limb fracture | 678 | 99.0 92.0–106.6ROR 108.4 · calibrated p 6e-8 ✓ | 95.3 EB05 89.4 · IC025 +6.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.3 (3.8–4.8) | No label text to screen label has no adverse-reaction text | serious PRR 67.8 · ♀ 100% (drug 65%) · 90% clinician | no trial arm names this drug |
| Fibromyalgia | 848 | 97.3 91.2–103.9ROR 109.1 · calibrated p 6e-8 ✓ | 93.7 EB05 88.6 · IC025 +6.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.0 (1.8–2.2) | No label text to screen label has no adverse-reaction text | serious PRR 79.8 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Liver injury | 786 | 90.4 84.5–96.7ROR 100.4 · calibrated p 1e-7 ✓ | 87.3 EB05 82.3 · IC025 +6.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.6 (2.3–2.9) | No label text to screen label has no adverse-reaction text | serious PRR 58.6 · ♀ 100% (drug 65%) · 95% clinician | no trial arm names this drug |
| Wound infection | 337 | 86.1 77.4–95.7ROR 89.9 · calibrated p 3e-7 ✓ | 83.0 EB05 75.8 · IC025 +6.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.6 (2.3–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 57.8 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Hypercholesterolaemia | 290 | 84.1 75.0–94.3ROR 87.3 · calibrated p 3e-7 ✓ | 81.1 EB05 73.6 · IC025 +6.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.5 (1.3–1.7) | No label text to screen label has no adverse-reaction text | serious PRR 56.0 · ♀ 99% (drug 65%) · 95% clinician | no trial arm names this drug |
| Wound | 823 | 82.1 76.8–87.6ROR 91.6 · calibrated p 2e-7 ✓ | 79.5 EB05 75.0 · IC025 +6.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.3 (2.1–2.5) | No label text to screen label has no adverse-reaction text | serious PRR 61.2 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Obesity | 430 | 74.5 67.9–81.8ROR 78.8 · calibrated p 7e-7 ✓ | 72.3 EB05 66.7 · IC025 +5.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.8 (1.6–2.0) | No label text to screen label has no adverse-reaction text | serious PRR 54.2 · ♀ 99% (drug 65%) · 95% clinician | no trial arm names this drug |
| Systemic lupus erythematosus | 888 | 69.3 65.0–73.8ROR 78.0 · calibrated p 7e-7 ✓ | 67.4 EB05 63.8 · IC025 +5.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.6) | No label text to screen label has no adverse-reaction text | serious PRR 44.7 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Prescribed overdose | 474 | 67.5 61.8–73.8ROR 71.9 · calibrated p 1e-6 ✓ | 65.7 EB05 60.9 · IC025 +5.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.2 (1.1–1.3) | No label text to screen label has no adverse-reaction text | serious PRR 72.3 · ♀ 98% (drug 65%) · 94% clinician | no trial arm names this drug |
| Impaired healing | 800 | 67.2 62.8–71.8ROR 74.7 · calibrated p 1e-6 ✓ | 65.4 EB05 61.7 · IC025 +5.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.2 (2.9–3.5) | Reporting / coding artifact | serious PRR 51.1 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Type 2 diabetes mellitus | 809 | 66.0 61.8–70.5ROR 73.5 · calibrated p 1e-6 ✓ | 64.3 EB05 60.7 · IC025 +5.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.6 (2.3–2.8) | No label text to screen label has no adverse-reaction text | serious PRR 43.8 · ♀ 100% (drug 65%) · 96% clinician | no trial arm names this drug |
| Pulmonary fibrosis | 447 | 64.4 58.8–70.6ROR 68.3 · calibrated p 2e-6 ✓ | 62.8 EB05 58.0 · IC025 +5.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.8 (2.5–3.2) | No label text to screen label has no adverse-reaction text | serious PRR 41.1 · ♀ 99% (drug 65%) · 96% clinician | no trial arm names this drug |
| Psoriatic arthropathy | 834 | 57.0 53.4–60.8ROR 63.7 · calibrated p 3e-6 ✓ | 55.7 EB05 52.6 · IC025 +5.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.6) | No label text to screen label has no adverse-reaction text | serious PRR 45.4 · ♀ 100% (drug 65%) · 95% clinician | no trial arm names this drug |
| Contraindicated product administered | 616 | 56.1 51.9–60.5ROR 60.8 · calibrated p 4e-6 ✓ | 54.9 EB05 51.3 · IC025 +5.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.2 (2.0–2.4) | Reporting / coding artifact | serious PRR 43.9 · ♀ 99% (drug 65%) · 92% clinician | no trial arm names this drug |
| Laryngitis | 214 | 54.1 47.3–61.8ROR 55.6 · calibrated p 7e-6 ✓ | 52.8 EB05 47.1 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.0 (1.7–2.4) | No label text to screen label has no adverse-reaction text | serious n=214 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Foot deformity | 212 | 52.4 45.8–59.9ROR 53.8 · calibrated p 9e-6 ✓ | 51.2 EB05 45.6 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.9 (1.6–2.3) | No label text to screen label has no adverse-reaction text | serious PRR 38.6 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Blood cholesterol increased | 890 | 52.3 49.2–55.7ROR 58.9 · calibrated p 5e-6 ✓ | 51.3 EB05 48.5 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.1 (1.9–2.3) | Lab value / disease marker | serious PRR 49.9 · ♀ 99% (drug 65%) · 94% clinician | no trial arm names this drug |
| Lower respiratory tract infection | 863 | 52.2 49.0–55.7ROR 58.6 · calibrated p 5e-6 ✓ | 51.2 EB05 48.4 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.4 (3.1–3.8) | No label text to screen label has no adverse-reaction text | serious PRR 35.0 · ♀ 99% (drug 65%) · 92% clinician | no trial arm names this drug |
| Hip arthroplasty | 276 | 49.8 44.3–56.0ROR 51.6 · calibrated p 1e-5 ✓ | 48.7 EB05 44.1 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.0 (1.7–2.3) | No label text to screen label has no adverse-reaction text | serious PRR 32.6 · ♀ 100% (drug 65%) · 95% clinician | no trial arm names this drug |
| Gait inability | 595 | 49.2 45.5–53.2ROR 53.2 · calibrated p 9e-6 ✓ | 48.3 EB05 45.1 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.9 (2.6–3.2) | No label text to screen label has no adverse-reaction text | serious PRR 38.8 · ♀ 100% (drug 65%) · 90% clinician | no trial arm names this drug |
| Arthropathy | 997 | 49.0 46.2–51.9ROR 56.0 · calibrated p 7e-6 ✓ | 48.0 EB05 45.6 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.6) | No label text to screen label has no adverse-reaction text | serious PRR 37.8 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Night sweats | 571 | 48.6 44.8–52.6ROR 52.3 · calibrated p 1e-5 ✓ | 47.6 EB05 44.4 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.3 (2.1–2.6) | No label text to screen label has no adverse-reaction text | serious PRR 52.5 · ♀ 100% (drug 65%) · 94% clinician | no trial arm names this drug |
| Road traffic accident | 683 | 44.6 41.5–48.0ROR 48.8 · calibrated p 2e-5 ✓ | 43.8 EB05 41.2 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.8 (1.7–2.0) | No label text to screen label has no adverse-reaction text | serious PRR 33.0 · ♀ 98% (drug 65%) | no trial arm names this drug |
| Osteoarthritis | 678 | 43.6 40.6–46.9ROR 47.7 · calibrated p 2e-5 ✓ | 42.9 EB05 40.3 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.7 (2.4–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 31.0 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Blister | 894 | 43.6 41.0–46.4ROR 49.1 · calibrated p 2e-5 ✓ | 42.9 EB05 40.6 · IC025 +5.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.6 (2.3–2.8) | No label text to screen label has no adverse-reaction text | serious PRR 45.8 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Pregnancy | 322 | 43.5 39.1–48.5ROR 45.3 · calibrated p 3e-5 ✓ | 42.7 EB05 38.9 · IC025 +5.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.3 (2.8–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 40.5 · ♀ 100% (drug 65%) · 97% clinician | no trial arm names this drug |
| Stomatitis (mouth sores) | 933 | 42.0 39.5–44.6ROR 47.6 · calibrated p 2e-5 ✓ | 41.3 EB05 39.2 · IC025 +5.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 3.1 (2.9–3.5) | No label text to screen label has no adverse-reaction text | serious PRR 39.9 · ♀ 99% (drug 65%) | no trial arm names this drug |
| Discomfort | 917 | 41.3 38.9–43.9ROR 46.7 · calibrated p 2e-5 ✓ | 40.7 EB05 38.5 · IC025 +5.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.9 (1.7–2.1) | No label text to screen label has no adverse-reaction text | serious PRR 46.0 · ♀ 99% (drug 65%) · 91% 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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 1,374 | 22.2 21.2–23.3ROR 26.7 · calibrated p 5e-4 ✓ | 22.0 EB05 21.1 · IC025 +4.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.7 (0.7–0.7) | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · ♀ 41% (drug 65%) · 93% clinician | no trial arm names this drug |
| Fatigue (tiredness) | 1,301 | 4.5 4.3–4.7ROR 5.2 · calibrated p 0.213 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.4 (0.4–0.5) | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · ♀ 94% (drug 65%) | no trial arm names this drug |
| Pain | 1,156 | 5.1 4.8–5.3ROR 5.8 · calibrated p 0.166 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.7 (0.7–0.7) | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · ♀ 97% (drug 65%) | no trial arm names this drug |
| Off label use (used outside approved label) | 1,114 | 3.5 3.3–3.7ROR 3.9 · calibrated p 0.404 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.3 (0.3–0.3) | Reporting / coding artifact | serious PRR 4.1 · ♀ 90% (drug 65%) · 90% clinician | no trial arm names this drug |
| Arthralgia (joint pain) | 1,094 | 7.1 6.7–7.5ROR 8.1 · calibrated p 0.064 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.1 (1.0–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · ♀ 98% (drug 65%) · 91% clinician | no trial arm names this drug |
| Vomiting | 1,082 | 6.2 5.9–6.6ROR 7.1 · calibrated p 0.096 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.7 (0.7–0.8) | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · ♀ 93% (drug 65%) | no trial arm names this drug |
| Alopecia (hair loss) | 1,079 | 14.8 14.0–15.7ROR 17.1 · calibrated p 0.004 ✓ | 14.7 EB05 14.0 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.5 (1.4–1.6) | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,075 | 5.1 4.8–5.4ROR 5.8 · calibrated p 0.165 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.9 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · ♀ 93% (drug 65%) | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,067 | 2.2 2.1–2.3ROR 2.4 · calibrated p 0.871 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.2 (0.2–0.2) | Reporting / coding artifact | serious PRR 3.7 · ♀ 91% (drug 65%) | no trial arm names this drug |
| Abdominal discomfort | 1,050 | 17.0 16.1–18.0ROR 19.5 · calibrated p 0.002 ✓ | 16.9 EB05 16.1 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 1.3 (1.2–1.4) | No label text to screen label has no adverse-reaction text | serious PRR 24.2 · ♀ 99% (drug 65%) | no trial arm names this drug |
| Condition aggravated | 1,047 | 9.4 8.8–9.9ROR 10.7 · calibrated p 0.026 ✓ | 9.3 EB05 8.8 · IC025 +3.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.7 (0.7–0.8) | Reporting / coding artifact | serious PRR 9.1 · ♀ 97% (drug 65%) | no trial arm names this drug |
| Headache | 1,025 | 4.4 4.2–4.7ROR 4.9 · calibrated p 0.243 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.4 (0.4–0.4) | No label text to screen label has no adverse-reaction text | serious PRR 5.4 · ♀ 94% (drug 65%) | no trial arm names this drug |
| Nausea | 1,019 | 3.5 3.3–3.7ROR 3.9 · calibrated p 0.407 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.4 (0.4–0.4) | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · ♀ 94% (drug 65%) | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,010 | 4.2 4.0–4.5ROR 4.7 · calibrated p 0.269 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 0.8 (0.8–0.9) | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 95% (drug 65%) | no trial arm names this drug |
| Arthropathy | 997 | 49.0 46.2–51.9ROR 56.0 · calibrated p 7e-6 ✓ | 48.0 EB05 45.6 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.6) | No label text to screen label has no adverse-reaction text | serious PRR 37.8 · ♀ 100% (drug 65%) · 91% 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 toxicity to various agents, fatigue, pain, arthralgia, vomiting, alopecia. 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, fieldpatient.drug.openfda.generic_name.exact, 515 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 2026-10-14. 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.