What the label lists and what reports show
Tetracaine side effects
Tetracaine's FDA label lists its adverse reactions in its own words. FAERS holds 123 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 toxic anterior segment syndrome (27 reports).
- Generic listed
Check it at the source: the tetracaine FDA label on DailyMed (effective January 19, 2024, Alcon Laboratories, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. …
Source: FDA drug label, Alcon Laboratories, Inc., effective January 19, 2024 (SPL set 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79), via openFDA; the full label on DailyMed
What do FAERS reports show?
123 reports list tetracaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 29 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 24 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.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tetracaine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions