pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Ion Channel Interactions.

Indications

Sourced from openFDA
  • ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.

Contraindications

Sourced from openFDA
  • ALCAINE™ ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.contraindicated

Dosage & administration

Sourced from openFDA

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. Short Corneal and Conjunctival Procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

Warnings & precautions

Sourced from openFDA

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss. ALCAINE™ ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. ALCAINE™ ophthalmic solution is not intended for patient self-administration.

Adverse reactions

Sourced from openFDA

Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. Corneal edema has been reported following the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported. Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.

Use in specific populations

Sourced from openFDA

Pregnancy: Animal reproduction studies have not been conducted with ALCAINE ™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

Approval history

Sourced from openFDA
  • Dec 22, 1971ANDAANDA080027Alcon Labs Inc
  • Sep 29, 1995ANDAANDA040074Bausch And Lomb Inc
  • Aug 9, 2024ANDAANDA215816Somerset Theraps Llc
  • May 21, 2025ANDAANDA219136Mankind Pharma
  • Oct 20, 2025ANDAANDA219294Micro Labs

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
516 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use8917%
  2. 2Conjunctival Hyperaemia6513%
  3. 3Eye Pain6112%
  4. 4Drug Abuse5911%
  5. 5Corneal Oedema5410%
  6. 6Hypopyon5210%
  7. 7Vision Blurred438.3%
  8. 8Corneal Epithelium Defect428.1%
  9. 9Ulcerative Keratitis367.0%
  10. 10Photophobia336.4%
  11. 11Visual Acuity Reduced336.4%
  12. 12Keratopathy326.2%
  13. 13Endophthalmitis285.4%
  14. 14Lacrimation Increased275.2%
  15. 15Corneal Infiltrates254.8%

Clinical trials

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The 10 most recently updated of 63 ClinicalTrials.gov registrations naming Proparacaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Proparacaine work?
Mechanism-of-action class: Ion Channel Interactions.
What is Proparacaine used for?
According to FDA labeling, Proparacaine carries indications including: ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Proparacaine?
Proparacaine is classified as Local anesthetics, Local Anesthetic, Ion Channel Interactions, Decreased Sensory-Somatic Nervous System Organized Electrical Activity, Local Anesthesia.
What are the brand names for Proparacaine?
Proparacaine is marketed under brand names including Alcaine, Flucaine, Fluoracaine.
What are the contraindications for Proparacaine?
Proparacaine labeling lists contraindications including: ALCAINE™ ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.. Always consult the full prescribing information and a clinician.
Note. Data for proparacaine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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