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What the label lists and what reports show

Proparacaine side effects

Proparacaine's FDA label lists its adverse reactions in its own words. FAERS holds 527 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 conjunctival hyperaemia (65 reports).

  • Generic listed

Check it at the source: the proparacaine FDA label on DailyMed (effective June 10, 2026, Alcon Laboratories, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

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.

Source: FDA drug label, Alcon Laboratories, Inc., effective June 10, 2026 (SPL set 0c0fa0bf-977d-4539-b8dc-54c187c5b094), via openFDA; the full label on DailyMed

What do FAERS reports show?

527 reports list proparacaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 35 are coded as a death and 132 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 23 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

  • Off Label Use (a use or a product term, not a reaction)89
  • Conjunctival Hyperaemia65
  • Eye Pain61
  • Drug Abuse59
  • Corneal Oedema (named in the label)55
  • Hypopyon53
  • Vision Blurred46
  • Corneal Epithelium Defect42
  • Ulcerative Keratitis36
  • Photophobia34
  • Visual Acuity Reduced33
  • Keratopathy32
  • Endophthalmitis28
  • Lacrimation Increased28
  • Corneal Infiltrates25
  • Persistent Corneal Epithelial Defect24
  • Toxic Anterior Segment Syndrome22
  • Intentional Product Use Issue (a use or a product term, not a reaction)21
  • Apnoea20
  • Eye Inflammation20
  • Vomiting20
  • Corneal Opacity19
  • Visual Impairment19
  • Cataract18
  • Abdominal Distension17

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Proparacaine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions