Drug · FAERS side-effect profile with label screen
Atropine Sulfate side effects: what 10,741 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
10,741 reports · 90% serious · 2,014 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 2Lab value / disease marker 1Not in label — unassessed 35
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. 1,078 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 |
|---|---|---|---|---|---|---|
| Schizencephaly | 12 | 722.1 372.0–1,401.7ROR 722.9 · χ² 5,771 / p <1e-300 | 286.1 EB05 174.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Vaginal flatulence | 76 | 647.6 499.7–839.2ROR 652.2 · χ² 36,235 / p <1e-300 | 431.9 EB05 356.4 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=76 · ♀ 100% (drug 49%) | no trial data cached |
| Anterior spinal artery syndrome | 17 | 488.6 287.0–831.7ROR 489.4 · χ² 6,215 / p <1e-300 | 271.1 EB05 179.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Cerebral haemorrhage foetal | 12 | 481.4 255.8–906.0ROR 482.0 · χ² 4,226 / p <1e-300 | 239.0 EB05 145.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rebound psychosis | 24 | 248.5 162.5–380.0ROR 249.0 · χ² 5,023 / p <1e-300 | 187.5 EB05 132.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Neuromuscular blockade | 13 | 118.1 67.5–206.7ROR 118.2 · χ² 1,314 / p 6e-288 | 96.0 EB05 59.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Retinal occlusive vasculitis | 12 | 116.1 64.9–207.9ROR 116.3 · χ² 1,185 / p 5e-260 | 93.7 EB05 57.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rhythm idioventricular | 18 | 114.4 71.1–184.0ROR 114.6 · χ² 1,804 / p <1e-300 | 97.2 EB05 65.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Multiple drug therapy | 36 | 106.2 75.9–148.4ROR 106.5 · χ² 3,455 / p <1e-300 | 95.7 EB05 72.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=36 · ♀ 100% (drug 49%) · 92% clinician | no trial data cached |
| Creatinine renal clearance increased | 38 | 103.9 75.0–144.0ROR 104.3 · χ² 3,579 / p <1e-300 | 94.1 EB05 71.6 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=38 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Female genital tract fistula | 87 | 103.9 83.8–128.8ROR 104.8 · χ² 8,318 / p <1e-300 | 96.6 EB05 80.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 100% (drug 49%) | no trial data cached |
| Keratitis fungal | 10 | 100.8 53.4–190.4ROR 100.9 · χ² 847 / p 2e-186 | 81.5 EB05 47.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Secondary hypogonadism | 16 | 100.0 60.5–165.3ROR 100.2 · χ² 1,399 / p <1e-300 | 85.7 EB05 55.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Anticholinergic syndrome | 76 | 97.8 77.7–123.0ROR 98.5 · χ² 6,836 / p <1e-300 | 91.0 EB05 75.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=76 · 97% clinician | no trial data cached |
| Anterior chamber flare | 11 | 95.8 52.3–175.6ROR 95.9 · χ² 895 / p 5e-197 | 79.2 EB05 47.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Neuromuscular block prolonged | 17 | 93.5 57.5–152.1ROR 93.7 · χ² 1,397 / p <1e-300 | 81.4 EB05 53.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Agitated depression | 12 | 84.6 47.5–150.8ROR 84.7 · χ² 872 / p 7e-192 | 72.2 EB05 44.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Choroidal detachment | 22 | 80.7 52.7–123.6ROR 80.9 · χ² 1,586 / p <1e-300 | 72.8 EB05 50.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Cholinergic syndrome | 25 | 79.1 53.0–117.9ROR 79.2 · χ² 1,776 / p <1e-300 | 72.0 EB05 51.3 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious n=24 · 100% clinician | no trial data cached |
| Seasonal affective disorder | 11 | 69.5 38.1–126.7ROR 69.5 · χ² 652 / p 5e-144 | 60.4 EB05 36.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hyperthermia malignant | 50 | 68.4 51.6–90.6ROR 68.7 · χ² 3,142 / p <1e-300 | 64.5 EB05 50.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 29% (drug 49%) · 100% clinician | no trial data cached |
| Hypotony of eye | 14 | 67.6 39.7–115.1ROR 67.7 · χ² 824 / p 2e-181 | 60.2 EB05 38.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Brash syndrome | 45 | 67.0 49.8–90.1ROR 67.2 · χ² 2,763 / p <1e-300 | 63.1 EB05 49.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=45 · 100% clinician | no trial data cached |
| Radiculopathy | 87 | 66.6 53.8–82.4ROR 67.1 · χ² 5,370 / p <1e-300 | 63.5 EB05 53.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 95% (drug 49%) | no trial data cached |
| Restrictive cardiomyopathy | 10 | 65.9 35.1–123.8ROR 66.0 · χ² 557 / p 2e-123 | 57.2 EB05 33.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Palmoplantar pustulosis | 16 | 63.1 38.4–103.8ROR 63.2 · χ² 888 / p 2e-195 | 57.2 EB05 37.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Pressure of speech | 20 | 61.9 39.7–96.6ROR 62.0 · χ² 1,103 / p 3e-242 | 56.9 EB05 38.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Chronic sinusitis | 102 | 54.6 44.9–66.4ROR 55.1 · χ² 5,170 / p <1e-300 | 52.6 EB05 44.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=102 · ♀ 100% (drug 49%) | no trial data cached |
| Sedation complication | 68 | 54.6 42.9–69.4ROR 54.9 · χ² 3,425 / p <1e-300 | 52.4 EB05 42.7 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=67 · ♀ 100% (drug 49%) | no trial data cached |
| Delusion of grandeur | 12 | 53.7 30.3–95.3ROR 53.8 · χ² 554 / p 8e-123 | 48.5 EB05 29.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Proctitis | 75 | 53.6 42.7–67.4ROR 54.0 · χ² 3,718 / p <1e-300 | 51.6 EB05 42.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=75 · ♀ 100% (drug 49%) | no trial data cached |
| Hyphaema | 14 | 53.5 31.5–90.9ROR 53.6 · χ² 651 / p 5e-144 | 48.8 EB05 30.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Vasoplegia syndrome | 40 | 49.6 36.2–67.8ROR 49.7 · χ² 1,809 / p <1e-300 | 47.3 EB05 36.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | no trial data cached |
| Delayed recovery from anaesthesia | 23 | 48.5 32.1–73.3ROR 48.6 · χ² 998 / p 2e-219 | 45.7 EB05 32.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Iris adhesions | 12 | 47.5 26.8–84.1ROR 47.5 · χ² 488 / p 2e-108 | 43.4 EB05 26.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anosognosia | 18 | 46.6 29.2–74.3ROR 46.7 · χ² 740 / p 3e-163 | 43.6 EB05 29.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Flight of ideas | 12 | 45.5 25.7–80.6ROR 45.5 · χ² 468 / p 6e-104 | 41.7 EB05 25.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Corneal perforation | 14 | 45.0 26.5–76.4ROR 45.1 · χ² 546 / p 4e-121 | 41.7 EB05 26.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Inflammatory pain | 15 | 44.2 26.5–73.7ROR 44.2 · χ² 577 / p 8e-128 | 41.1 EB05 26.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Stress cardiomyopathy | 123 | 42.4 35.5–50.6ROR 42.9 · χ² 4,825 / p <1e-300 | 41.3 EB05 35.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 87% (drug 49%) · 97% 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 920 | 1.4 1.3–1.5ROR 1.4 · χ² 95 / p 9e-23 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Off label use (used outside approved label) | 778 | 1.8 1.6–1.9ROR 1.8 · χ² 260 / p 7e-59 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Diarrhoea (diarrhea) | 717 | 2.2 2.0–2.3ROR 2.3 · χ² 469 / p 2e-104 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Nausea | 686 | 1.7 1.6–1.8ROR 1.7 · χ² 204 / p 2e-46 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hypotension (low blood pressure) | 579 | 5.7 5.2–6.1ROR 5.9 · χ² 2,230 / p <1e-300 | 5.6 EB05 5.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Fatigue (tiredness) | 569 | 1.4 1.3–1.5ROR 1.5 · χ² 76 / p 1e-18 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Death | 563 | 1.3 1.2–1.4ROR 1.3 · χ² 35 / p 2e-9 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Pain | 507 | 1.6 1.5–1.8ROR 1.6 · χ² 120 / p 4e-28 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Vomiting | 473 | 2.0 1.8–2.2ROR 2.0 · χ² 230 / p 3e-52 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 470 | 1.6 1.5–1.8ROR 1.7 · χ² 115 / p 4e-27 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 1.4 | no trial data cached |
| Bradycardia (slow heart rate) | 452 | 16.7 15.3–18.3ROR 17.4 · χ² 6,635 / p <1e-300 | 16.6 EB05 15.4 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · 93% clinician | no trial data cached |
| Pyrexia (fever) | 444 | 2.5 2.3–2.7ROR 2.6 · χ² 406 / p 1e-90 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Cardiac arrest (heart stopping) | 374 | 8.8 8.0–9.8ROR 9.1 · χ² 2,594 / p <1e-300 | 8.8 EB05 8.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 92% clinician | no trial data cached |
| Toxicity to various agents | 367 | 4.3 3.9–4.7ROR 4.4 · χ² 923 / p 4e-203 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Constipation | 365 | 3.3 3.0–3.6ROR 3.4 · χ² 587 / p 6e-130 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · ♀ 70% (drug 49%) | 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.
- Vaginal flatulence — n=76, PRR 647.6
- Rebound psychosis — n=24, PRR 248.5
- Female genital tract fistula — n=87, PRR 103.9
- Anticholinergic syndrome — n=76, PRR 97.8
- Choroidal detachment — n=22, PRR 80.7
- Hyperthermia malignant — n=50, PRR 68.4
- Brash syndrome — n=45, PRR 67.0
- Radiculopathy — n=87, PRR 66.6
- Pressure of speech — n=20, PRR 61.9
- Chronic sinusitis — n=102, PRR 54.6
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, pain, vomiting. 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, 1,118 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.