Last reviewed · How we verify
CYCLOPENTOLATE HYDROCHLORIDE
At a glance
| Generic name | CYCLOPENTOLATE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
Common side effects
- Blurred vision
- Photophobia
- Burning/irritation upon instillation
- Increased intraocular pressure
- Superficial punctate keratitis
- Hallucinations
- Restlessness
- Hyperactivity
- Incoherent speech
- Ataxia
- Disorientation
- Tachycardia
Serious adverse events
- Seizures
- Psychotic reactions
- Behavioral disturbances
- Convulsion
- Coma
- Medullary paralysis
- Death
- Cerebrovascular accidents
- Syncope
- Necrotizing colitis
Key clinical trials
- Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children (PHASE4)
- Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children (NA)
- Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC (NA)
- Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery
- Cycloplegic Refraction in Pediatric Patients With Esotropia (PHASE4)
- The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy (NA)
- Prevalence of Refractive Errors in Primary School Children
- Mydriatic Drops After Combined Surgery (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CYCLOPENTOLATE HYDROCHLORIDE CI brief — competitive landscape report
- CYCLOPENTOLATE HYDROCHLORIDE updates RSS · CI watch RSS