Drugs › Cholinergic receptor agonist
Brand name · Aceclidine
Vizz: adverse event reports filed with FDA
596 reports list it as a suspect or interacting product, 2025–2026. Class: Cholinergic receptor agonist.
- 596
- reports as suspect product
- 0% of all reports · about 596 a year
- 596
- reports, 12 months to June 2026
- 0 in the 12 months before
- 3.4%
- marked serious by the reporter
- 19.5% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
596 adverse event reports received by FDA list the brand name Vizz (aceclidine) as a suspect or interacting product, from October 2025 to June 2026. A further 1 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 596 reports listed it, with none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 596 reports a year and 0% of the 20,646,523 reports in the database, and 8.8% of the reports for the cholinergic receptor agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded ocular hyperaemia (45%), visual impairment (35.1%) and instillation site irritation (33.6%). A report can list several reactions, so shares add to more than 100%; 64 different terms appear across these reports. Ocular hyperaemia is recorded in 45% of these reports, a larger share than in the median cholinergic receptor agonist drug (4.7%).
3.4% of the reports are marked serious by the reporter (19.5% across the class); 0% record death among the outcomes and 0% record hospitalisation, as reported. 52.9% of the reports came from consumers, and the largest patient age group is 45 to 64 (27.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
Reactions recorded in the reports
share of Vizz reports recording the termmedian drug in cholinergic receptor agonist
- Ocular hyperaemiaa red eye45%268
- Visual impairmentreduced vision35.1%209
- Instillation site irritation33.6%200
- Headachehead pain22.8%136
- Vision blurredblurred vision12.6%75
- Drug ineffectivethe medicine did not work as expected11.1%66
- Nauseafeeling sick4.7%28
- Vitreous floatersfloaters in vision4.7%28
- Off label useused for a purpose or in a way not on the label4.5%27
- Dizzinesslight-headedness or unsteadiness3.7%22
- Condition aggravatedthe condition being treated got worse2.7%16
- Visual acuity reducedreduced sharpness of vision2.5%15
- Ocular discomfort2.3%14
- Miosis2.2%13
- Migrainemigraine2%12
- Eye paineye pain1.8%11
- Lacrimation increasedwatery eyes1.8%11
- Asthenopia1.7%10
- Photopsia1.7%10
- Eye irritationeye irritation1.5%9
- Pseudomyopia1.5%9
- Vitreous detachment1.3%8
- Vomitingbeing sick1.2%7
- Dyspnoeashortness of breath1%6
- Instillation site pain1%6
- Instillation site pruritus1%6
- Intentional product use issuedeliberate use not as intended1%6
Top 30 of 64 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the cholinergic receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 6,746 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Presbyopia | 573 | 96.1% |
| Halo vision | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 596 reports.
In context
| Measure | Vizz | Cholinergic receptor agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 596 | 6,746 | 20,646,523 |
| Share of that pool | — | 8.8% | 0% |
| Reports, latest 12 months | 596 | — | 1,332,454 |
| Marked serious | 3.4% | 19.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 7 | 91 |
| Hospitalisation recorded, per 1,000 reports | 0 | 43 | 213 |
| Consumer-filed share | 52.9% | 50.6% | 45.8% |
| Top term, share of reports | Ocular hyperaemia 45% | median 4.7% | 0.2% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the cholinergic receptor agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Varenicline | generic | 2,680 | 335 | 38.2% |
| Tyrvaya | brand | 2,608 | 95 | 5.7% |
| Vuity | brand | 862 | 9 | 14.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Vizz reports
How many adverse event reports has FDA received for Vizz?
596 reports list Vizz as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 596 of them arrived in the latest 12 months. Another 1 list it only as a concomitant medication.
What reactions are recorded in Vizz reports?
ocular hyperaemia (45%), visual impairment (35.1%), instillation site irritation (33.6%), headache (22.8%) and vision blurred (12.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Vizz was responsible.
How serious are the reports?
3.4% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (52.9%), physician (40.4%) and other health professional (6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Vizz rising?
596 reports in the 12 months to June 2026, with none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Vizz was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Vizz?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Vizz as a suspect or interacting product; reports listing it only as a concomitant medication (1) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.