What the label lists and what reports show
Cyclopentolate side effects
Cyclopentolate's FDA label lists its adverse reactions in its own words. FAERS holds 645 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 eye pain (60 reports).
- Generic listed
Check it at the source: the cyclopentolate FDA label on DailyMed (effective June 25, 2024, Alcon Laboratories, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsOcular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. …
Source: FDA drug label, Alcon Laboratories, Inc., effective June 25, 2024 (SPL set 1d008c76-7210-4ace-90fa-7cd22762e12e), via openFDA; the full label on DailyMed
What do FAERS reports show?
645 reports list cyclopentolate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 148 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 22 reactions below, 1 is 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cyclopentolate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions