Drug · FAERS side-effect profile with label screen
Atropine side effects: what 8,236 FDA adverse event reports show
Drug class
Anticholinergic, Cholinergic Muscarinic Antagonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Atropen Auto-Injector
openFDA label
Who reports
8,236 reports · 92% serious · 1,615 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. ATROPEN is a cholinergic muscarinic a.
FDA label, Indications and Usage
What it is
Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration.
FDA label, Description section
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
Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 32
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 1,043 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 |
|---|---|---|---|---|---|---|
| Anterior spinal artery syndrome | 12 | 418.5 227.2–770.9ROR 419.1 · χ² 3,934 / p <1e-300 | 228.6 EB05 139.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rebound psychosis | 20 | 264.3 166.8–418.8ROR 265.0 · χ² 4,512 / p <1e-300 | 195.0 EB05 133.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Vaginal flatulence | 21 | 187.7 120.5–292.2ROR 188.1 · χ² 3,456 / p <1e-300 | 151.0 EB05 104.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Neuromuscular blockade | 13 | 154.0 88.0–269.5ROR 154.2 · χ² 1,720 / p <1e-300 | 120.0 EB05 74.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Multiple drug therapy | 36 | 138.4 99.0–193.5ROR 139.0 · χ² 4,526 / p <1e-300 | 122.8 EB05 92.7 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=36 · ♀ 100% (drug 49%) · 92% clinician | no trial data cached |
| Creatinine renal clearance increased | 37 | 131.8 94.8–183.3ROR 132.4 · χ² 4,440 / p <1e-300 | 117.8 EB05 89.2 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=37 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Keratitis fungal | 10 | 131.5 69.6–248.2ROR 131.6 · χ² 1,110 / p 1e-243 | 101.4 EB05 58.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Secondary hypogonadism | 16 | 130.5 79.0–215.5ROR 130.7 · χ² 1,833 / p <1e-300 | 108.4 EB05 70.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Retinal occlusive vasculitis | 10 | 124.9 66.2–235.7ROR 125.1 · χ² 1,056 / p 6e-232 | 97.5 EB05 56.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Rhythm idioventricular | 13 | 106.0 60.9–184.5ROR 106.2 · χ² 1,198 / p 7e-263 | 88.9 EB05 55.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Neuromuscular block prolonged | 14 | 99.6 58.4–169.8ROR 99.8 · χ² 1,221 / p 8e-268 | 85.1 EB05 53.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Anticholinergic syndrome | 53 | 87.6 66.6–115.0ROR 88.1 · χ² 4,300 / p <1e-300 | 82.2 EB05 65.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=53 · 96% clinician | no trial data cached |
| Brash syndrome | 45 | 87.3 64.9–117.5ROR 87.8 · χ² 3,628 / p <1e-300 | 81.6 EB05 63.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=45 · 100% clinician | no trial data cached |
| Restrictive cardiomyopathy | 10 | 86.0 45.8–161.5ROR 86.1 · χ² 732 / p 2e-161 | 72.2 EB05 41.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Palmoplantar pustulosis | 16 | 82.3 50.1–135.4ROR 82.5 · χ² 1,167 / p 4e-256 | 73.1 EB05 47.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cholinergic syndrome | 18 | 73.4 45.9–117.2ROR 73.5 · χ² 1,179 / p 1e-258 | 66.5 EB05 44.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious n=17 | no trial data cached |
| Sedation complication | 67 | 70.1 55.0–89.2ROR 70.6 · χ² 4,372 / p <1e-300 | 67.0 EB05 54.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=66 · ♀ 100% (drug 49%) | no trial data cached |
| Hypotony of eye | 11 | 68.7 37.8–125.0ROR 68.8 · χ² 650 / p 1e-143 | 60.3 EB05 35.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hyperthermia malignant | 36 | 63.6 45.7–88.4ROR 63.8 · χ² 2,102 / p <1e-300 | 60.1 EB05 45.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 26% (drug 49%) · 100% clinician | no trial data cached |
| Choroidal detachment | 13 | 61.1 35.3–105.9ROR 61.2 · χ² 693 / p 5e-153 | 55.1 EB05 34.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pressure of speech | 15 | 60.1 36.0–100.2ROR 60.2 · χ² 794 / p 5e-175 | 54.8 EB05 35.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Inflammatory pain | 15 | 57.6 34.5–96.0ROR 57.7 · χ² 761 / p 8e-168 | 52.8 EB05 33.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Cardiac procedure complication | 13 | 55.2 31.9–95.7ROR 55.3 · χ² 625 / p 3e-138 | 50.3 EB05 31.3 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Vasoplegia syndrome | 32 | 51.4 36.3–73.0ROR 51.6 · χ² 1,502 / p <1e-300 | 49.1 EB05 36.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | no trial data cached |
| Stress cardiomyopathy | 99 | 44.3 36.4–54.0ROR 44.8 · χ² 4,077 / p <1e-300 | 43.2 EB05 36.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 85% (drug 49%) · 96% clinician | no trial data cached |
| Stoma site pain | 25 | 44.2 29.8–65.7ROR 44.4 · χ² 996 / p 6e-219 | 42.2 EB05 30.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 49%) · 92% clinician | no trial data cached |
| Anosognosia | 13 | 43.6 25.2–75.4ROR 43.7 · χ² 491 / p 5e-109 | 40.5 EB05 25.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cataract subcapsular | 10 | 42.5 22.8–79.4ROR 42.5 · χ² 359 / p 3e-80 | 38.9 EB05 22.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Corneal perforation | 10 | 41.6 22.3–77.8ROR 41.7 · χ² 351 / p 1e-78 | 38.2 EB05 22.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Bradycardia foetal | 13 | 41.1 23.7–71.0ROR 41.1 · χ² 461 / p 1e-102 | 38.3 EB05 23.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Delayed recovery from anaesthesia | 15 | 40.9 24.6–68.1ROR 41.0 · χ² 536 / p 7e-119 | 38.5 EB05 24.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Mitral valve calcification | 10 | 40.1 21.5–74.8ROR 40.1 · χ² 337 / p 1e-75 | 36.9 EB05 21.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Creatinine renal clearance decreased | 61 | 39.1 30.4–50.3ROR 39.4 · χ² 2,194 / p <1e-300 | 38.1 EB05 30.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=61 · ♀ 100% (drug 49%) | no trial data cached |
| Systolic dysfunction | 15 | 36.7 22.1–61.2ROR 36.8 · χ² 479 / p 1e-106 | 34.8 EB05 22.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Female genital tract fistula | 24 | 36.0 24.1–53.8ROR 36.1 · χ² 771 / p 7e-170 | 34.6 EB05 24.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 49%) | no trial data cached |
| Intestinal pseudo-obstruction | 12 | 36.0 20.3–63.5ROR 36.0 · χ² 368 / p 2e-82 | 33.7 EB05 20.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Choroidal effusion | 11 | 35.5 19.6–64.4ROR 35.6 · χ² 330 / p 4e-74 | 33.2 EB05 19.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Sinus arrest | 21 | 35.0 22.8–53.9ROR 35.1 · χ² 652 / p 5e-144 | 33.6 EB05 23.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Change of bowel habit | 27 | 34.0 23.3–49.7ROR 34.1 · χ² 821 / p 9e-181 | 32.8 EB05 23.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 49%) · 92% clinician | no trial data cached |
| Qrs axis abnormal | 10 | 33.4 17.9–62.4ROR 33.5 · χ² 279 / p 5e-63 | 31.2 EB05 18.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 624 | 1.2 1.1–1.3ROR 1.2 · χ² 23 / p 7e-7 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Off label use (used outside approved label) | 579 | 1.7 1.6–1.8ROR 1.8 · χ² 173 / p 9e-40 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 574 | 2.3 2.1–2.5ROR 2.4 · χ² 420 / p 1e-93 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Nausea | 506 | 1.6 1.5–1.8ROR 1.7 · χ² 128 / p 5e-30 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Hypotension (low blood pressure) | 504 | 6.4 5.9–7.0ROR 6.8 · χ² 2,317 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Fatigue (tiredness) | 487 | 1.6 1.5–1.7ROR 1.6 · χ² 112 / p 2e-26 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Death | 447 | 1.3 1.2–1.4ROR 1.3 · χ² 36 / p 9e-10 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 415 | 1.9 1.7–2.1ROR 1.9 · χ² 171 / p 2e-39 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Bradycardia (slow heart rate) | 393 | 19.0 17.2–20.9ROR 19.9 · χ² 6,636 / p <1e-300 | 18.8 EB05 17.3 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 · 92% clinician | no trial data cached |
| Pain | 384 | 1.6 1.4–1.8ROR 1.6 · χ² 86 / p 1e-20 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Vomiting | 372 | 2.0 1.8–2.2ROR 2.1 · χ² 195 / p 1e-44 | 2.0 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Cardiac arrest (heart stopping) | 314 | 9.7 8.7–10.8ROR 10.0 · χ² 2,436 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 92% clinician | no trial data cached |
| Toxicity to various agents | 298 | 4.5 4.0–5.1ROR 4.7 · χ² 820 / p 1e-180 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Pyrexia (fever) | 293 | 2.2 1.9–2.4ROR 2.2 · χ² 183 / p 5e-42 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Drug interaction | 261 | 4.2 3.7–4.7ROR 4.3 · χ² 635 / p 2e-140 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 94% clinician | 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.
- Rebound psychosis — n=20, PRR 264.3
- Vaginal flatulence — n=21, PRR 187.7
- Anticholinergic syndrome — n=53, PRR 87.6
- Brash syndrome — n=45, PRR 87.3
- Hyperthermia malignant — n=36, PRR 63.6
- Vasoplegia syndrome — n=32, PRR 51.4
- Stress cardiomyopathy — n=99, PRR 44.3
- Stoma site pain — n=25, PRR 44.2
- Female genital tract fistula — n=24, PRR 36.0
- Sinus arrest — n=21, PRR 35.0
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 Atropine?
In FDA FAERS, the most frequently co-reported reaction terms for Atropine are diarrhoea, nausea, hypotension, fatigue, dyspnoea, bradycardia. 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 Atropine have an FDA boxed warning?
No. The FDA label retrieved for Atropine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atropine 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 e2d4307d-da8f-49f5-aac0-02355dd9ffb7, effective 20220915; matched on
openfda.generic_name.exact:"ATROPINE") - 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, 1,083 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.