Acetylcholine side effects: what 92 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Acetylcholine Chloride (Miochol E)
Who reports
92 reports · 80% serious · 0 with death outcome · 74% female
Used for
To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
What it is
DESCRIPTION Miochol ™ -E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one diluent ampule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol.
Boxed warning
None in the current label
Causality screen of the 15 strongest signals
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 30 | 650.3 484.5–872.9ROR 964.5 · χ² 18,761 / p <1e-300 | 458.1 EB05 336.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 616.4 · ♀ 100% (drug 74%) | no trial data cached |
| Sleep disorder due to a general medical condition | 34 | 480.2 367.5–627.3ROR 761.1 · χ² 15,761 / p <1e-300 | 377.2 EB05 282.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 679.1 · ♀ 100% (drug 74%) | no trial data cached |
| Eosinophilia | 33 | 431.3 328.0–567.0ROR 671.9 · χ² 13,724 / p <1e-300 | 344.4 EB05 256.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 322.5 · ♀ 100% (drug 74%) | no trial data cached |
| Sinus disorder | 33 | 379.9 288.9–499.4ROR 591.8 · χ² 12,085 / p <1e-300 | 310.9 EB05 231.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 585.3 · ♀ 100% (drug 74%) | no trial data cached |
| Mental impairment | 33 | 310.3 236.1–407.9ROR 483.3 · χ² 9,866 / p <1e-300 | 262.8 EB05 195.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 279.5 · ♀ 100% (drug 74%) | no trial data cached |
| Respiratory disorder | 33 | 251.0 190.9–329.9ROR 390.8 · χ² 7,971 / p <1e-300 | 219.0 EB05 163.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 222.3 · ♀ 100% (drug 74%) | no trial data cached |
| Mental disorder | 33 | 172.7 131.4–227.0ROR 268.7 · χ² 5,469 / p <1e-300 | 157.0 EB05 117.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.1 · ♀ 100% (drug 74%) | no trial data cached |
| Productive cough (cough with phlegm) | 33 | 159.0 121.0–209.0ROR 247.4 · χ² 5,032 / p <1e-300 | 145.7 EB05 108.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.2 · ♀ 100% (drug 74%) | no trial data cached |
| Loss of personal independence in daily activities | 31 | 148.7 111.6–198.1ROR 223.7 · χ² 4,408 / p <1e-300 | 136.3 EB05 100.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.1 · ♀ 100% (drug 74%) | no trial data cached |
| Chronic obstructive pulmonary disease | 33 | 144.4 109.8–189.7ROR 224.5 · χ² 4,564 / p <1e-300 | 133.3 EB05 99.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 120.5 · ♀ 100% (drug 74%) | no trial data cached |
| Wheezing | 33 | 127.2 96.8–167.2ROR 197.8 · χ² 4,016 / p <1e-300 | 118.6 EB05 88.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 125.5 · ♀ 100% (drug 74%) | no trial data cached |
| Rhinorrhoea (runny nose) | 34 | 120.3 92.1–157.1ROR 190.2 · χ² 3,914 / p <1e-300 | 112.8 EB05 84.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.2 · ♀ 100% (drug 74%) | no trial data cached |
| Nasal congestion (stuffy nose) | 30 | 116.9 87.1–156.8ROR 172.9 · χ² 3,339 / p <1e-300 | 108.9 EB05 79.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 187.9 · ♀ 100% (drug 74%) | no trial data cached |
| Therapeutic product effect incomplete | 34 | 109.6 83.9–143.2ROR 173.3 · χ² 3,563 / p <1e-300 | 103.4 EB05 77.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 147.6 · ♀ 100% (drug 74%) | no trial data cached |
| Breast cancer | 33 | 80.0 60.9–105.1ROR 124.2 · χ² 2,506 / p <1e-300 | 76.6 EB05 57.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.5 · ♀ 100% (drug 74%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Therapeutic product effect incomplete | 34 | 109.6 83.9–143.2ROR 173.3 · χ² 3,563 / p <1e-300 | 103.4 EB05 77.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 147.6 · ♀ 100% (drug 74%) | no trial data cached |
| Rhinorrhoea (runny nose) | 34 | 120.3 92.1–157.1ROR 190.2 · χ² 3,914 / p <1e-300 | 112.8 EB05 84.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.2 · ♀ 100% (drug 74%) | no trial data cached |
| Sleep disorder due to a general medical condition | 34 | 480.2 367.5–627.3ROR 761.1 · χ² 15,761 / p <1e-300 | 377.2 EB05 282.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 679.1 · ♀ 100% (drug 74%) | no trial data cached |
| Breast cancer | 33 | 80.0 60.9–105.1ROR 124.2 · χ² 2,506 / p <1e-300 | 76.6 EB05 57.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.5 · ♀ 100% (drug 74%) | no trial data cached |
| Wheezing | 33 | 127.2 96.8–167.2ROR 197.8 · χ² 4,016 / p <1e-300 | 118.6 EB05 88.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 125.5 · ♀ 100% (drug 74%) | no trial data cached |
| Chronic obstructive pulmonary disease | 33 | 144.4 109.8–189.7ROR 224.5 · χ² 4,564 / p <1e-300 | 133.3 EB05 99.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 120.5 · ♀ 100% (drug 74%) | no trial data cached |
| Productive cough (cough with phlegm) | 33 | 159.0 121.0–209.0ROR 247.4 · χ² 5,032 / p <1e-300 | 145.7 EB05 108.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.2 · ♀ 100% (drug 74%) | no trial data cached |
| Mental disorder | 33 | 172.7 131.4–227.0ROR 268.7 · χ² 5,469 / p <1e-300 | 157.0 EB05 117.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.1 · ♀ 100% (drug 74%) | no trial data cached |
| Respiratory disorder | 33 | 251.0 190.9–329.9ROR 390.8 · χ² 7,971 / p <1e-300 | 219.0 EB05 163.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 222.3 · ♀ 100% (drug 74%) | no trial data cached |
| Mental impairment | 33 | 310.3 236.1–407.9ROR 483.3 · χ² 9,866 / p <1e-300 | 262.8 EB05 195.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 279.5 · ♀ 100% (drug 74%) | no trial data cached |
| Sinus disorder | 33 | 379.9 288.9–499.4ROR 591.8 · χ² 12,085 / p <1e-300 | 310.9 EB05 231.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 585.3 · ♀ 100% (drug 74%) | no trial data cached |
| Eosinophilia | 33 | 431.3 328.0–567.0ROR 671.9 · χ² 13,724 / p <1e-300 | 344.4 EB05 256.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 322.5 · ♀ 100% (drug 74%) | no trial data cached |
| Loss of personal independence in daily activities | 31 | 148.7 111.6–198.1ROR 223.7 · χ² 4,408 / p <1e-300 | 136.3 EB05 100.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.1 · ♀ 100% (drug 74%) | no trial data cached |
| Nasal congestion (stuffy nose) | 30 | 116.9 87.1–156.8ROR 172.9 · χ² 3,339 / p <1e-300 | 108.9 EB05 79.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 187.9 · ♀ 100% (drug 74%) | no trial data cached |
| Full blood count abnormal | 30 | 650.3 484.5–872.9ROR 964.5 · χ² 18,761 / p <1e-300 | 458.1 EB05 336.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 616.4 · ♀ 100% (drug 74%) | 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 Acetylcholine?
In FDA FAERS, the most frequently co-reported reaction terms for Acetylcholine are rhinorrhoea, sleep disorder due to a general medical condition, breast cancer, wheezing, chronic obstructive pulmonary disease, productive cough. 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 Acetylcholine have an FDA boxed warning?
No. The FDA label retrieved for Acetylcholine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acetylcholine 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 e701ef07-9499-4b56-931f-f4eb3eedbe24, effective 20230317; matched on
openfda.generic_name.exact:"ACETYLCHOLINE CHLORIDE") - 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, 17 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.