Drug · FAERS side-effect profile with label screen
Activated Charcoal side effects: what 624 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Actidose
openFDA label
Who reports
624 reports · 93% serious · 173 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• For emergency use to adsorb swallowed poisons.
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 6Outcome field, not a reaction 1No label text to screen 33
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 17 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 |
|---|---|---|---|---|---|---|
| Obesity | 54 | 114.1 88.4–147.3ROR 124.8 · χ² 5,926 / p <1e-300 | 109.4 EB05 87.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.4 · ♀ 100% (drug 63%) | no trial data cached |
| Knee arthroplasty | 62 | 100.2 79.1–127.0ROR 111.2 · χ² 5,979 / p <1e-300 | 97.0 EB05 78.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.1 | no trial data cached |
| Cardiogenic shock | 42 | 99.2 74.0–132.9ROR 106.3 · χ² 3,976 / p <1e-300 | 94.7 EB05 73.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.9 · ♀ 32% (drug 63%) | no trial data cached |
| Schizophrenia | 24 | 66.4 44.9–98.4ROR 69.1 · χ² 1,480 / p <1e-300 | 63.1 EB05 44.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.4 · ♀ 0% (drug 63%) | no trial data cached |
| Lower respiratory tract infection | 83 | 61.7 50.5–75.3ROR 71.0 · χ² 4,894 / p <1e-300 | 60.7 EB05 50.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.1 | no trial data cached |
| Gastrointestinal pain | 18 | 55.3 35.1–87.2ROR 56.9 · χ² 905 / p 4e-199 | 52.3 EB05 35.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.7 | no trial data cached |
| Intentional overdose | 101 | 53.3 44.6–63.8ROR 63.4 · χ² 5,141 / p <1e-300 | 52.7 EB05 44.7 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 34.1 | no trial data cached |
| Ileus | 19 | 52.0 33.4–80.9ROR 53.6 · χ² 898 / p 1e-197 | 49.5 EB05 33.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 | no trial data cached |
| Arthropathy | 82 | 49.5 40.4–60.5ROR 56.8 · χ² 3,850 / p <1e-300 | 48.9 EB05 40.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 | no trial data cached |
| Lactic acidosis | 46 | 48.2 36.5–63.7ROR 52.0 · χ² 2,081 / p <1e-300 | 47.3 EB05 36.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · ♀ 40% (drug 63%) · 93% clinician | no trial data cached |
| Shock | 32 | 47.2 33.7–66.1ROR 49.7 · χ² 1,400 / p <1e-300 | 45.9 EB05 34.1 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.2 | no trial data cached |
| Hypothermia | 13 | 43.1 25.2–73.9ROR 44.0 · χ² 493 / p 1e-109 | 40.7 EB05 25.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.9 | no trial data cached |
| Intentional product misuse | 98 | 38.0 31.6–45.5ROR 44.8 · χ² 3,500 / p <1e-300 | 37.7 EB05 31.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 53.1 | no trial data cached |
| Drug abuse | 93 | 37.4 31.0–45.1ROR 43.8 · χ² 3,268 / p <1e-300 | 37.1 EB05 31.2 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 23.3 | no trial data cached |
| Metabolic acidosis | 32 | 34.0 24.3–47.7ROR 35.8 · χ² 993 / p 3e-218 | 33.4 EB05 24.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 · 100% clinician | no trial data cached |
| Suicide attempt | 61 | 33.8 26.6–42.9ROR 37.3 · χ² 1,911 / p <1e-300 | 33.4 EB05 27.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Electrocardiogram qt prolonged | 33 | 30.8 22.1–43.0ROR 32.5 · χ² 924 / p 3e-203 | 30.3 EB05 22.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.3 · ♀ 83% (drug 63%) · 100% clinician | no trial data cached |
| Ventricular fibrillation | 10 | 30.2 16.3–55.9ROR 30.7 · χ² 254 / p 2e-57 | 28.6 EB05 16.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 | no trial data cached |
| Mydriasis | 11 | 28.9 16.1–51.9ROR 29.4 · χ² 269 / p 1e-60 | 27.5 EB05 16.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.0 | no trial data cached |
| Sinus tachycardia | 12 | 28.5 16.3–49.9ROR 29.0 · χ² 291 / p 1e-65 | 27.3 EB05 16.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 | no trial data cached |
| Circulatory collapse | 14 | 27.5 16.4–46.2ROR 28.1 · χ² 332 / p 2e-74 | 26.6 EB05 16.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 | no trial data cached |
| Product administration error | 16 | 27.0 16.6–43.7ROR 27.6 · χ² 374 / p 1e-83 | 26.2 EB05 17.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 40.6 | no trial data cached |
| Generalised tonic-clonic seizure | 13 | 26.7 15.6–45.8ROR 27.3 · χ² 297 / p 9e-67 | 25.7 EB05 15.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 | no trial data cached |
| Toxicity to various agents | 133 | 26.7 22.9–31.0ROR 33.6 · χ² 3,282 / p <1e-300 | 26.5 EB05 23.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 · 90% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 27 | 26.0 18.0–37.6ROR 27.1 · χ² 625 / p 3e-138 | 25.6 EB05 18.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 · ♀ 8% (drug 63%) · 96% clinician | no trial data cached |
| Completed suicide (death by suicide) | 65 | 26.0 20.6–32.7ROR 28.9 · χ² 1,541 / p <1e-300 | 25.8 EB05 20.9 · IC025 +4.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 16.0 · 100% clinician | no trial data cached |
| Overdose | 164 | 25.5 22.3–29.0ROR 34.2 · χ² 3,866 / p <1e-300 | 25.4 EB05 22.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 | no trial data cached |
| Altered state of consciousness | 16 | 25.0 15.4–40.5ROR 25.6 · χ² 345 / p 3e-77 | 24.3 EB05 15.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.5 | no trial data cached |
| Tachypnoea | 10 | 24.8 13.4–45.9ROR 25.2 · χ² 205 / p 7e-47 | 23.6 EB05 13.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 | no trial data cached |
| Oral pain | 16 | 23.9 14.8–38.8ROR 24.6 · χ² 329 / p 7e-74 | 23.3 EB05 15.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.1 | no trial data cached |
| Depressed level of consciousness | 28 | 23.9 16.6–34.3ROR 24.9 · χ² 591 / p 7e-131 | 23.5 EB05 17.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.1 | no trial data cached |
| Irritable bowel syndrome | 15 | 23.6 14.3–38.9ROR 24.2 · χ² 303 / p 4e-68 | 22.9 EB05 14.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Coma | 33 | 23.3 16.7–32.4ROR 24.5 · χ² 682 / p 1e-150 | 23.0 EB05 17.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.4 · 94% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 36 | 22.8 16.6–31.3ROR 24.1 · χ² 729 / p 6e-161 | 22.5 EB05 17.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.5 · ♀ 26% (drug 63%) · 97% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 28 | 22.6 15.7–32.5ROR 23.6 · χ² 558 / p 1e-123 | 22.3 EB05 16.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · ♀ 4% (drug 63%) · 96% clinician | no trial data cached |
| Mucosal inflammation | 16 | 20.6 12.7–33.5ROR 21.2 · χ² 280 / p 4e-63 | 20.1 EB05 12.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.5 | no trial data cached |
| Lung neoplasm malignant | 25 | 20.3 13.9–29.9ROR 21.2 · χ² 441 / p 3e-98 | 20.0 EB05 14.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · ♀ 0% (drug 63%) | no trial data cached |
| Drug level increased | 10 | 20.3 11.0–37.5ROR 20.6 · χ² 165 / p 5e-38 | 19.1 EB05 10.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 | no trial data cached |
| Dementia | 16 | 19.3 11.9–31.3ROR 19.8 · χ² 260 / p 8e-59 | 18.7 EB05 11.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 | no trial data cached |
| Cerebral infarction | 14 | 19.2 11.5–32.3ROR 19.7 · χ² 224 / p 5e-51 | 18.5 EB05 11.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | 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 |
|---|---|---|---|---|---|---|
| Overdose | 164 | 25.5 22.3–29.0ROR 34.2 · χ² 3,866 / p <1e-300 | 25.4 EB05 22.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 | no trial data cached |
| Toxicity to various agents | 133 | 26.7 22.9–31.0ROR 33.6 · χ² 3,282 / p <1e-300 | 26.5 EB05 23.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 · 90% clinician | no trial data cached |
| Intentional overdose | 101 | 53.3 44.6–63.8ROR 63.4 · χ² 5,141 / p <1e-300 | 52.7 EB05 44.7 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 34.1 | no trial data cached |
| Intentional product misuse | 98 | 38.0 31.6–45.5ROR 44.8 · χ² 3,500 / p <1e-300 | 37.7 EB05 31.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 53.1 | no trial data cached |
| Drug abuse | 93 | 37.4 31.0–45.1ROR 43.8 · χ² 3,268 / p <1e-300 | 37.1 EB05 31.2 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 23.3 | no trial data cached |
| Abdominal discomfort | 85 | 17.1 14.0–20.8ROR 19.6 · χ² 1,282 / p 5e-281 | 17.0 EB05 14.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.1 | no trial data cached |
| Lower respiratory tract infection | 83 | 61.7 50.5–75.3ROR 71.0 · χ² 4,894 / p <1e-300 | 60.7 EB05 50.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.1 | no trial data cached |
| Arthropathy | 82 | 49.5 40.4–60.5ROR 56.8 · χ² 3,850 / p <1e-300 | 48.9 EB05 40.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 | no trial data cached |
| Completed suicide (death by suicide) | 65 | 26.0 20.6–32.7ROR 28.9 · χ² 1,541 / p <1e-300 | 25.8 EB05 20.9 · IC025 +4.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 16.0 · 100% clinician | no trial data cached |
| Knee arthroplasty | 62 | 100.2 79.1–127.0ROR 111.2 · χ² 5,979 / p <1e-300 | 97.0 EB05 78.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.1 | no trial data cached |
| Suicide attempt | 61 | 33.8 26.6–42.9ROR 37.3 · χ² 1,911 / p <1e-300 | 33.4 EB05 27.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Obesity | 54 | 114.1 88.4–147.3ROR 124.8 · χ² 5,926 / p <1e-300 | 109.4 EB05 87.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.4 · ♀ 100% (drug 63%) | no trial data cached |
| Lactic acidosis | 46 | 48.2 36.5–63.7ROR 52.0 · χ² 2,081 / p <1e-300 | 47.3 EB05 36.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · ♀ 40% (drug 63%) · 93% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 44 | 17.9 13.4–23.7ROR 19.1 · χ² 686 / p 2e-151 | 17.7 EB05 13.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · ♀ 37% (drug 63%) · 98% clinician | no trial data cached |
| Cardiogenic shock | 42 | 99.2 74.0–132.9ROR 106.3 · χ² 3,976 / p <1e-300 | 94.7 EB05 73.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.9 · ♀ 32% (drug 63%) | 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 Activated Charcoal?
In FDA FAERS, the most frequently co-reported reaction terms for Activated Charcoal are toxicity to various agents, abdominal discomfort, lower respiratory tract infection, arthropathy, knee arthroplasty, suicide attempt. 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 Activated Charcoal have an FDA boxed warning?
No. The FDA label retrieved for Activated Charcoal has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Activated Charcoal 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 76e4fe6a-afd4-4f68-b12d-0b094f750615, effective 20260728; matched on
openfda.generic_name.exact:"ACTIVATED CHARCOAL") - 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, 57 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.