Cyclopentolate Ophthalmic
Cyclopentolate ophthalmic is an eye drop used to dilate the pupil and temporarily paralyze the eye's focusing muscle — most often for eye exams and procedures.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Cyclopentolate (Cyclogyl) is an eye drop that blocks nerve signals to the pupil and focusing muscle, dilating the pupil and briefly freezing focus so your eye doctor can see inside the eye and measure an accurate prescription; a standard exam drop since about 1975, especially for children, it is available as a generic. Most people tolerate it well, noticing stinging as it goes in, then blurry vision and light sensitivity that usually fade within 24 hours but can linger for days. In infants and young children, watch for confusion, hallucinations, a fast heartbeat or fever afterward, because brain and heart side effects are most likely at that age.
Clinical pearls
- Bring sunglasses and arrange a driver, since a dilated pupil and frozen focus make bright light and driving hard for hours.
- Gentle pressure on the inner corner of the eye after the drop limits how much reaches the bloodstream, which matters most in infants.
- Tell the eye doctor first if you have glaucoma or narrow angles, because these drops can raise pressure inside the eye.
- It can weaken pilocarpine, carbachol and similar pressure-lowering glaucoma drops, so mention every eye drop you use.
Patient information guide A plain-language walkthrough of Cyclopentolate Ophthalmic, written from its FDA label.
What Cyclopentolate Ophthalmic is used for
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Cyclopentolate hydrochloride ophthalmic solution is used to temporarily dilate the pupil and paralyze the focusing muscle of the eye for diagnostic and examination purposes.
- Mydriasis (pupil dilation) — widens the pupil so the eye care provider can see the back of the eye clearly
- Cycloplegia (temporary paralysis of accommodation) — stops the focusing muscle from working, allowing an accurate measurement of the eye's refractive error (prescription)
How Cyclopentolate Ophthalmic works
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Cyclopentolate is an anticholinergic drug, meaning it blocks the action of acetylcholine — a chemical messenger in the nervous system. In the eye, it targets two specific muscles: the sphincter muscle of the iris (which normally narrows the pupil) and the ciliary body muscle (which controls the lens's ability to focus). By blocking signals to these muscles, cyclopentolate causes the pupil to open wide and the eye to temporarily lose its ability to focus up close.
It acts faster than atropine, a similar drug, but its effects wear off sooner. Darkly pigmented irises may require a higher concentration because the pigment can bind the drug, requiring more of it to take effect.
Cyclopentolate Ophthalmic dosage
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Cyclopentolate is placed directly in the eye as drops. Adults typically receive one or two drops, and a second application may be given about five to ten minutes later if needed; complete recovery from the effects usually occurs within 24 hours, though pupil dilation may take several days to fully resolve in some individuals. Children follow a similar schedule, while small infants should receive only a single drop of the lowest available strength, with gentle pressure applied over the inner corner of the eye afterward. Always follow your eye care provider's specific instructions regarding timing and number of drops.
Dosing details from the FDA-approved label
From the Cyclopentolate Ophthalmic prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults
- Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary
- Complete recovery usually occurs in 24 hours
- Complete recovery from mydriasis in some individuals may require several days
- Individuals with heavily pigmented irides may require higher strengths.
- Children
- Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary
- Individuals with heavily pigmented irides may require higher strengths.
- Small Infants
- A single instillation of one drop of 0.5% Cyclopentolate Hydrochloride Ophthalmic Solution in the eye
- To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes; observe infant closely for at least 30 minutes following instillation.
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% Cyclopentolate Hydrochloride Ophthalmic Solution in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.
Read the full Dosage and Administration section on DailyMed →
Cyclopentolate Ophthalmic side effects
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Eye-related side effects are the most common, but the drug can also affect other parts of the body — especially in children and infants.
Common side effects
- Burning or stinging in the eye
- Blurred vision
- Sensitivity to light (photophobia)
- Eye redness or irritation
- Temporarily raised pressure in the eye
- Drowsiness, especially in children
- Conjunctivitis (eye inflammation) or irritation of the eyelids
- Drowsiness, especially in younger patients
When to get medical help
- Call your doctor if you or your child shows confusion, hallucinations, restlessness, or slurred speech after use
- Seek help right away if you notice a fast heartbeat (tachycardia) or high fever (hyperpyrexia)
- Get medical help if you experience sudden eye pain or worsening eye pressure
- In infants: watch closely for at least 30 minutes after drops are given and call for help if breathing or heart rate seems abnormal
- Seek care immediately if severe symptoms such as seizures or loss of consciousness occur
More serious reactions — including confusion, hallucinations, fast heartbeat, high fever, or seizures — require immediate medical attention, particularly in children and infants who are most vulnerable.
Cyclopentolate Ophthalmic warnings and precautions
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- CNS effects in children and infants: Cyclopentolate can cause psychotic reactions, hallucinations, restlessness, incoherent speech, disorientation, and seizures — especially in children and with stronger concentrations. Infants are at the highest risk and must be observed for at least 30 minutes after use.
- Heart and breathing effects in infants: Cardiopulmonary (heart and lung) side effects are a real concern in small infants. Use only one drop of the lowest strength per eye and press over the inner corner of the eye to minimize absorption.
- Raised eye pressure: The drops can temporarily increase pressure inside the eye, which is dangerous for people with untreated narrow-angle glaucoma or anatomically narrow angles.
- For the eye only: This solution is strictly for topical ophthalmic use and must never be injected.
- Prolonged pupil dilation: In some individuals, especially those with dark irises, dilation may last several days.
Cyclopentolate Ophthalmic interactions
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Cyclopentolate can interfere with other eye medications that lower pressure inside the eye.
- Carbachol — cyclopentolate may reduce its eye pressure-lowering effect
- Pilocarpine — cyclopentolate may reduce its eye pressure-lowering effect
- Ophthalmic cholinesterase inhibitors — cyclopentolate may counteract their action in the eye
Interactions listed in the FDA-approved label
From the Cyclopentolate Ophthalmic prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Carbachol: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol.
- Pilocarpine: Cyclopentolate may interfere with the ocular anti-hypertensive action of pilocarpine.
- Ophthalmic cholinesterase inhibitors: Cyclopentolate may interfere with the ocular anti-hypertensive action of ophthalmic cholinesterase inhibitors.
Read the label’s full interactions text
Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Cyclopentolate Ophthalmic
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- Do not use if you have untreated narrow-angle glaucoma or anatomically narrow angles — the drops can trigger a dangerous pressure spike
- Do not use if you are allergic to any component of the solution
- Infants are especially vulnerable to CNS and heart-related side effects — use only as directed and observe closely
- People with heavily pigmented (darker) irises may need a higher strength to achieve the desired effect
- Tell your provider about all other eye drops you use, particularly glaucoma medications
Cyclopentolate Ophthalmic overdose
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Too much cyclopentolate — whether from too many drops or absorption into the bloodstream — can cause a fast heartbeat, high fever, high blood pressure, behavioral disturbances, urinary retention, and reduced activity in the digestive system and certain glands. In severe cases, it can lead to coma or worse. Anyone showing signs of overdose should receive supportive care and medical monitoring right away.
What Cyclopentolate Ophthalmic does in the body
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Cyclopentolate dilates the pupil and paralyzes the eye's focusing ability by blocking muscarinic receptors in the iris and ciliary body. Peak cycloplegia (full loss of focusing ability) occurs within 25 to 75 minutes of instillation. Accommodation (the ability to focus) usually returns within 6 to 24 hours, though full recovery from pupil dilation can take several days in some people — and even longer in those with deeply pigmented irises.
How to store Cyclopentolate Ophthalmic
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Store between 15°C to 25°C (59°F to 77°F). KEEP OUT OF REACH OF CHILDREN.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Cyclopentolate Ophthalmic
17 supplements and herbal products have documented interactions with Cyclopentolate Ophthalmic in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Cyclopentolate Ophthalmic: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cyclopentolate Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
Why did my eye doctor put these drops in my eyes before my exam?
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How long will my vision be blurry and my eyes sensitive to light?
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Are these drops safe for my child or infant?
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What side effects should I just expect versus ones I need to call someone about?
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Will these drops interact with my other eye medications?
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I have glaucoma — can I still get these drops?
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Is Cyclopentolate Ophthalmic available over the counter?
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When was Cyclopentolate Ophthalmic first available?
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Who makes Cyclopentolate Ophthalmic?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cyclopentolate Ophthalmic on HelloPharmacist
Cyclopentolate Ophthalmic forms and strengths (how it comes)
Cyclopentolate Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Cyclopentolate Ophthalmic inactive ingredients by manufacturer.
Eye drops
How this form is used
- Used to produce pupil dilation (mydriasis) and paralysis of the eye's focusing muscle (cycloplegia) to allow thorough eye examination
- Cyclogyl is the brand name for cyclopentolate hydrochloride ophthalmic solution
- Instill one or two drops into the affected eye; a second application may be given five to ten minutes later if needed
- For small infants: use only a single drop per eye; press gently over the inner corner of the eye for two to three minutes afterward to limit absorption
- Individuals with heavily pigmented (darker) irises may need a higher strength concentration to achieve full effect
- This solution is for the eye only — never inject it
Cyclopentolate Ophthalmic on the U.S. market: products, makers and brands
How Cyclopentolate Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 5 Cyclopentolate Ophthalmic product records with the FDA, mostly as eye drops; the earliest marketing or approval year on record is 1974. Brand names on the directory include Cyclogyl, Akpentolate, Pentolair and 1 more; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Cyclopentolate Ophthalmic is used (Medicaid data)
A general measure of how commonly Cyclopentolate Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cyclopentolate Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cyclopentolate Ophthalmic prescribed? Of the 1,601 medications we measure, Cyclopentolate Ophthalmic ranks #790 by Medicaid prescriptions — more than 51% of them.
Utilization by Cyclopentolate Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution Most dispensed
Summed across the 6 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1298066
cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1298072
cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1298070
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cyclopentolate Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 19 listed Cyclopentolate Ophthalmic NDCs with Medicaid activity.
Compare Cyclopentolate Ophthalmic products
A representative set of FDA-listed product records for Cyclopentolate Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 5 mg/mL | Ophthalmic | Alcon Laboratories, Inc. | ANDA | View NDC → |
| 10 mg/mL | Ophthalmic | Alcon Laboratories, Inc. | ANDA | View NDC → |
| 20 mg/mL | Ophthalmic | Alcon Laboratories, Inc. | ANDA | View NDC → |
| 10 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | ANDA | View NDC → |
| 10 mg/mL | Ophthalmic | Sandoz Inc. | ANDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Cyclopentolate Ophthalmic NDCs →
Cyclopentolate Ophthalmic side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cyclopentolate Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cyclopentolate Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cyclopentolate Ophthalmic FDA approval history
How Cyclopentolate Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Cyclopentolate Ophthalmic recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Cyclopentolate recalls since July 2021.
✅No Cyclopentolate recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3001 1 dose form · 3 strengths
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Dose form (SCDF) Ophthalmic Solution RxCUI 377444In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MG/MLRxCUI 1298066hydrochloride 20 MG/MLRxCUI 1298070hydrochloride 5 MG/MLRxCUI 1298072
Look up RxCUI 3001 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Cyclopentolate Ophthalmic supply and shortage status
Whether Cyclopentolate Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Cyclopentolate Ophthalmic costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Solution/ Drops · Ophthalmic | 5 mg/mL | $6.40 per mL | NDC details & price history |
| Solution/ Drops · Ophthalmic | 20 mg/mL | $14.63–$22.10 per mL | NDC details & price history |
| Solution · Ophthalmic | 10 mg/mL | $0.870–$2.65 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Cyclopentolate Ophthalmic brand names
Cyclopentolate Ophthalmic is sold under 4 brand names in the FDA directory — Cyclogyl, Akpentolate, Pentolair, Cylate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Cyclopentolate Ophthalmic: manufacturers and labelers
3 companies list Cyclopentolate Ophthalmic products with the FDA. By number of product records, the largest are Alcon Laboratories, Inc., Bausch & Lomb Incorporated, Sandoz Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Cyclopentolate Ophthalmic drug class (RxNorm)
Cyclopentolate Ophthalmic belongs to the Anticholinergics class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Cyclopentolate Ophthalmic page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Alcon Laboratories, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →