Proparacaine
/api/v1/drug/proparacaineMechanism of action
Sourced from openFDAMechanism-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 openFDAUsual 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 openFDANOT 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 openFDAOccasional 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 openFDAPregnancy: 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
- 1Off Label Use8917%
- 2Conjunctival Hyperaemia6513%
- 3Eye Pain6112%
- 4Drug Abuse5911%
- 5Corneal Oedema5410%
- 6Hypopyon5210%
- 7Vision Blurred438.3%
- 8Corneal Epithelium Defect428.1%
- 9Ulcerative Keratitis367.0%
- 10Photophobia336.4%
- 11Visual Acuity Reduced336.4%
- 12Keratopathy326.2%
- 13Endophthalmitis285.4%
- 14Lacrimation Increased275.2%
- 15Corneal Infiltrates254.8%
Clinical trials
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.
- Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)Recruiting · Interventional · 20 enrolled · Ain Shams UniversityNCT07633457updated 2026-06-08
- Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal InjectionsEnrolling by invitation · Phase 4 · Interventional · 236 enrolled · Harrow IncNCT07456826updated 2026-04-07
- Efficacy of Nanodropper-mediated Topical AnestheticCompleted · Phase 4 · Interventional · 56 enrolled · Columbia UniversityNCT06636708updated 2026-02-12
- Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)Suspended · Observational · 1,000 enrolled · Tufts Medical CenterNCT04838223updated 2026-01-27
- Study of Stimulus Parameters in Flicker Electroretinogram (ERG)Completed · Interventional · 18 enrolled · LKC Technologies, Inc.NCT02466607updated 2025-12-17
- Subthreshold Micropulse Laser Therapy (SML) in Retinitis PigmentosaEnrolling by invitation · Interventional · 60 enrolled · Marta P. WiącekNCT07088705updated 2025-07-31
- An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens DiscomfortCompleted · Interventional · 22 enrolled · Johnson & Johnson Vision Care, Inc.NCT03733899updated 2025-04-25
- Optic Nerve Head Structural Response to IOP Elevation in Patients With KeratoconusTerminated · Interventional · 3 enrolled · NYU Langone HealthNCT03560609updated 2025-01-29
- Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and PainRecruiting · Interventional · 36 enrolled · Dongyang People's HospitalNCT06393855updated 2024-07-11
- VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High MyopiaCompleted · Interventional · 114 enrolled · London Vision ClinicNCT02528123updated 2024-04-23
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.
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.