Aceclidine side effects: what 599 FDA adverse event reports show

Aceclidine · Vizz · 8 reaction terms · 684 drug–reaction co-reports · data 2026-09-14

Drug class

Cholinergic agonist

FDA label, Indications wording

Brand names

Vizz

openFDA label

Who reports

599 reports · 4% serious · 0 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VIZZ is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).

FDA label, Indications and Usage

What it is

VIZZ (aceclidine ophthalmic solution) 1.44% is a cholinergic muscarinic receptor agonist supplied as a sterile, clear to opalescent, colorless to slightly yellow, and viscous ophthalmic solution containing 1.75% of aceclidine hydrochloride (equivalent to 1.44% aceclidine).

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 8 strongest signals

Labeled (related wording) 1Reporting / coding artifact 2Not in label — unassessed 5

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.
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.
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
Ocular hyperaemia	268	202.0 184.7–220.9ROR 364.7 · χ² 53,202 / p <1e-300	198.0 EB05 178.9 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 144.7	no trial data cached
Drug effect less than expected	59	147.1 115.4–187.5ROR 163.1 · χ² 8,386 / p <1e-300	139.9 EB05 112.4 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Vitreous floaters	28	100.9 70.3–145.0ROR 105.8 · χ² 2,665 / p <1e-300	94.3 EB05 68.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=6 · ♀ 81% (drug 60%)	no trial data cached
Visual impairment	210	59.9 53.7–66.8ROR 91.6 · χ² 12,145 / p <1e-300	59.4 EB05 53.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 40.1	no trial data cached
Ocular discomfort	14	45.2 26.9–75.8ROR 46.2 · χ² 561 / p 3e-124	42.7 EB05 27.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product dose omission in error	15	19.6 11.9–32.2ROR 20.0 · χ² 246 / p 9e-56	18.9 EB05 11.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 84.5	no trial data cached
Vision blurred (blurred vision)	75	19.2 15.6–23.8ROR 21.8 · χ² 1,286 / p 8e-282	19.1 EB05 15.8 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1	no trial data cached
Visual acuity reduced	15	15.7 9.5–25.9ROR 16.1 · χ² 192 / p 6e-44	14.9 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	–	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
Ocular hyperaemia	268	202.0 184.7–220.9ROR 364.7 · χ² 53,202 / p <1e-300	198.0 EB05 178.9 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 144.7	no trial data cached
Visual impairment	210	59.9 53.7–66.8ROR 91.6 · χ² 12,145 / p <1e-300	59.4 EB05 53.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 40.1	no trial data cached
Vision blurred (blurred vision)	75	19.2 15.6–23.8ROR 21.8 · χ² 1,286 / p 8e-282	19.1 EB05 15.8 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1	no trial data cached
Drug effect less than expected	59	147.1 115.4–187.5ROR 163.1 · χ² 8,386 / p <1e-300	139.9 EB05 112.4 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Vitreous floaters	28	100.9 70.3–145.0ROR 105.8 · χ² 2,665 / p <1e-300	94.3 EB05 68.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=6 · ♀ 81% (drug 60%)	no trial data cached
Visual acuity reduced	15	15.7 9.5–25.9ROR 16.1 · χ² 192 / p 6e-44	14.9 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product dose omission in error	15	19.6 11.9–32.2ROR 20.0 · χ² 246 / p 9e-56	18.9 EB05 11.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 84.5	no trial data cached
Ocular discomfort	14	45.2 26.9–75.8ROR 46.2 · χ² 561 / p 3e-124	42.7 EB05 27.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	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.

Ocular hyperaemia — n=268, PRR 202.0
Vitreous floaters — n=28, PRR 100.9
Visual impairment — n=210, PRR 59.9

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 Aceclidine?

In FDA FAERS, the most frequently co-reported reaction terms for Aceclidine are ocular hyperaemia, visual impairment, vision blurred, vitreous floaters, visual acuity reduced, ocular discomfort. 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 Aceclidine have an FDA boxed warning?

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

Do FAERS signals prove that Aceclidine 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 7aed8024-ad30-44d6-8f3b-63338ad3ce52, effective 20260114; matched on openfda.generic_name.exact:"ACECLIDINE")
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, 8 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.