FDA label 85266dd5-ab35-47c3-b881-0707de31404f

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
1b97597f-f2e7-4574-81a8-f35b769c957a
SPL ID
85266dd5-ab35-47c3-b881-0707de31404f
Version
13
Effective date
2023-05-02
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:06:13

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. As with all ophthalmic preparations containing benzalkonium chloride, patients should be instructed not to wear soft contact lenses during treatment with ALOMIDE ® (lodoxamide tromethamine ophthalmic solution) 0.1%. Do not touch the dropper tip to any surface, as this may contaminate the solution.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: During clinical studies of ALOMIDE ® (lodoxamide tromethamine ophthalmic solution) 0.1%, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in approximately 15% of the subjects. Other ocular events occurring in 1% to 5% of the subjects included ocular itching/pruritus, blurred vision, dry eye, tearing/discharge, hyperemia, crystalline deposits, and foreign body sensation. Events that occurred in less than 1% of the subjects included corneal erosion/ulcer, scales on lid/lash, eye pain, ocular edema/swelling, ocular warming sensation, ocular fatigue, chemosis, corneal abrasion, anterior chamber cells, keratopathy/keratitis, blepharitis, allergy, sticky sensation, and epitheliopathy. Nonocular events reported were headache (1.5%) and (at less than 1%) heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.