Skip to main content

What the label lists and what reports show

Aceclidine side effects

Aceclidine's FDA label: “The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%) ( 6.1 ).” FAERS holds 599 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ocular hyperaemia (268 reports).

  • No generic listed

Check it at the source: the aceclidine FDA label on DailyMed (effective January 14, 2026, LENZ Therapeutics, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%) ( 6.1 ).

From the label: adverse reactions, continued

The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact LENZ Therapeutics, Inc. at 1-888-711-LENZ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VIZZ dosed once daily was evaluated for safety and efficacy in 466 participants with presbyopia in 2 randomized, double-masked, controlled phase 3 studies for 42 days (CLARITY-1, NCT05656027 and CLARITY-2, NCT05728944). VIZZ dosed once daily was also evaluated for long term safety in 217 participants with presbyopia in a separate randomized, double-masked, controlled phase 3 study (CLARITY-3, NCT05753189) for a 6-month duration. The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in > 5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving.

Source: FDA drug label, LENZ Therapeutics, Inc., effective January 14, 2026 (SPL set 7aed8024-ad30-44d6-8f3b-63338ad3ce52), via openFDA; the full label on DailyMed

What do FAERS reports show?

599 reports list aceclidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Ocular Hyperaemia (named in the label)268
  • Visual Impairment210
  • Instillation Site Irritation (named in the label)200
  • Headache (named in the label)137
  • Vision Blurred75
  • Drug Ineffective (a use or a product term, not a reaction)66
  • Drug Effect Less Than Expected59
  • Nausea28
  • Off Label Use (a use or a product term, not a reaction)28
  • Vitreous Floaters28
  • Dizziness22
  • Condition Aggravated (a use or a product term, not a reaction)16
  • Product Dose Omission In Error (a use or a product term, not a reaction)15
  • Visual Acuity Reduced15
  • Ocular Discomfort14
  • Miosis13
  • Eye Pain12
  • Foreign Body Sensation In Eyes12
  • Migraine12
  • Asthenopia11
  • Lacrimation Increased11
  • Photopsia10
  • Eye Irritation9
  • Pseudomyopia9
  • Vitreous Detachment8

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Aceclidine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions