Carbachol side effects: what 162 FDA adverse event reports show

Carbachol · Miostat · 19 reaction terms · 292 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Miostat

openFDA label

Who reports

162 reports · 78% serious · 3 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.

FDA label, Indications and Usage

What it is

DESCRIPTION: MIOSTAT™ (carbachol intraocular solution, USP) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure: Established Name: Carbachol

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 19 strongest signals

Labeled adverse reaction 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 9

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Obesity	26	211.2 148.5–300.5ROR 251.4 · χ² 5,228 / p <1e-300	182.8 EB05 131.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 179.8 · ♀ 100% (drug 68%)	no trial data cached
Knee arthroplasty	23	142.9 97.9–208.8ROR 166.4 · χ² 3,101 / p <1e-300	127.9 EB05 89.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 109.2 · ♀ 100% (drug 68%)	no trial data cached
Eye inflammation	9	123.6 65.5–233.3ROR 130.8 · χ² 975 / p 3e-214	98.4 EB05 55.4 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Cardiomegaly	11	114.9 64.9–203.3ROR 123.2 · χ² 1,130 / p 5e-248	96.1 EB05 57.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 86.6	no trial data cached
Bronchospasm (airway tightening)	11	99.5 56.2–176.1ROR 106.7 · χ² 977 / p 1e-214	85.2 EB05 50.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 80.7	no trial data cached
Hyperthyroidism	11	98.5 55.7–174.3ROR 105.6 · χ² 966 / p 2e-212	84.5 EB05 50.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 77.6	no trial data cached
Blood test abnormal	9	83.0 44.0–156.7ROR 87.8 · χ² 650 / p 1e-143	71.0 EB05 40.0 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 93.3	no trial data cached
Lower respiratory tract infection	27	77.2 54.7–108.9ROR 92.4 · χ² 1,957 / p <1e-300	73.3 EB05 52.9 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 59.9 · ♀ 100% (drug 68%)	no trial data cached
Post procedural complication	11	74.0 41.8–131.0ROR 79.4 · χ² 721 / p 3e-159	65.9 EB05 39.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 37.7	no trial data cached
Sputum discoloured	5	68.5 28.9–162.4ROR 70.6 · χ² 268 / p 1e-60	54.8 EB05 25.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 65.8	no trial data cached
Product administration error	10	64.9 35.6–118.3ROR 69.1 · χ² 567 / p 1e-125	58.1 EB05 33.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 116.5	no trial data cached
Visual acuity reduced	16	61.9 38.8–98.5ROR 68.5 · χ² 899 / p 7e-198	57.8 EB05 37.7 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 53.6	no trial data cached
Full blood count abnormal	5	61.4 25.9–145.6ROR 63.3 · χ² 240 / p 2e-54	50.1 EB05 22.8 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 59.9	no trial data cached
Arthropathy	26	60.4 42.4–85.8ROR 71.7 · χ² 1,462 / p <1e-300	57.9 EB05 41.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 54.0 · ♀ 100% (drug 68%)	no trial data cached
Drug abuse	27	41.8 29.6–59.0ROR 49.9 · χ² 1,038 / p 4e-228	40.7 EB05 29.4 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 31.0 · ♀ 100% (drug 68%)	no trial data cached
Sleep disorder due to a general medical condition	5	40.0 16.9–94.9ROR 41.3 · χ² 153 / p 2e-35	34.4 EB05 14.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 58.2	no trial data cached
Intentional product misuse	26	38.8 27.2–55.1ROR 46.0 · χ² 922 / p 6e-203	37.8 EB05 27.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 64.6 · ♀ 100% (drug 68%)	no trial data cached
Eye pruritus	9	35.3 18.7–66.7ROR 37.4 · χ² 267 / p 2e-60	33.0 EB05 18.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 96.4	no trial data cached
Drug dependence	25	19.9 13.9–28.5ROR 23.3 · χ² 433 / p 2e-96	19.6 EB05 13.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9 · ♀ 100% (drug 68%)	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 abuse	27	41.8 29.6–59.0ROR 49.9 · χ² 1,038 / p 4e-228	40.7 EB05 29.4 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 31.0 · ♀ 100% (drug 68%)	no trial data cached
Lower respiratory tract infection	27	77.2 54.7–108.9ROR 92.4 · χ² 1,957 / p <1e-300	73.3 EB05 52.9 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 59.9 · ♀ 100% (drug 68%)	no trial data cached
Intentional product misuse	26	38.8 27.2–55.1ROR 46.0 · χ² 922 / p 6e-203	37.8 EB05 27.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 64.6 · ♀ 100% (drug 68%)	no trial data cached
Arthropathy	26	60.4 42.4–85.8ROR 71.7 · χ² 1,462 / p <1e-300	57.9 EB05 41.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 54.0 · ♀ 100% (drug 68%)	no trial data cached
Obesity	26	211.2 148.5–300.5ROR 251.4 · χ² 5,228 / p <1e-300	182.8 EB05 131.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 179.8 · ♀ 100% (drug 68%)	no trial data cached
Drug dependence	25	19.9 13.9–28.5ROR 23.3 · χ² 433 / p 2e-96	19.6 EB05 13.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9 · ♀ 100% (drug 68%)	no trial data cached
Knee arthroplasty	23	142.9 97.9–208.8ROR 166.4 · χ² 3,101 / p <1e-300	127.9 EB05 89.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 109.2 · ♀ 100% (drug 68%)	no trial data cached
Visual acuity reduced	16	61.9 38.8–98.5ROR 68.5 · χ² 899 / p 7e-198	57.8 EB05 37.7 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 53.6	no trial data cached
Post procedural complication	11	74.0 41.8–131.0ROR 79.4 · χ² 721 / p 3e-159	65.9 EB05 39.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 37.7	no trial data cached
Hyperthyroidism	11	98.5 55.7–174.3ROR 105.6 · χ² 966 / p 2e-212	84.5 EB05 50.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 77.6	no trial data cached
Bronchospasm (airway tightening)	11	99.5 56.2–176.1ROR 106.7 · χ² 977 / p 1e-214	85.2 EB05 50.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 80.7	no trial data cached
Cardiomegaly	11	114.9 64.9–203.3ROR 123.2 · χ² 1,130 / p 5e-248	96.1 EB05 57.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 86.6	no trial data cached
Product administration error	10	64.9 35.6–118.3ROR 69.1 · χ² 567 / p 1e-125	58.1 EB05 33.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 116.5	no trial data cached
Eye pruritus	9	35.3 18.7–66.7ROR 37.4 · χ² 267 / p 2e-60	33.0 EB05 18.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 96.4	no trial data cached
Blood test abnormal	9	83.0 44.0–156.7ROR 87.8 · χ² 650 / p 1e-143	71.0 EB05 40.0 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 93.3	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.

Obesity — n=26, PRR 211.2
Knee arthroplasty — n=23, PRR 142.9
Lower respiratory tract infection — n=27, PRR 77.2
Arthropathy — n=26, PRR 60.4

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 Carbachol?

In FDA FAERS, the most frequently co-reported reaction terms for Carbachol are lower respiratory tract infection, arthropathy, obesity, knee arthroplasty, visual acuity reduced, hyperthyroidism. 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 Carbachol have an FDA boxed warning?

No. The FDA label retrieved for Carbachol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Carbachol 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 f28d7a56-e079-4a8b-ad81-9a97c780de67, effective 20230210; matched on openfda.generic_name.exact:"CARBACHOL")
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, field patient.drug.openfda.generic_name.exact, 19 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.