Home FDA labels f149bcd8-9403-4c3b-ac96-723cb55cc4c9 FDA label f149bcd8-9403-4c3b-ac96-723cb55cc4c9 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 e5c6b084-f6f8-4c14-a742-48b0f4d9b9a7
SPL ID f149bcd8-9403-4c3b-ac96-723cb55cc4c9
Version 5
Effective date 2022-05-19
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:43:09 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS The most frequently reported adverse experience was headache (~40%). Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 to 30% of patients. Other events occurring between 1 to 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis. Some of these events were similar to the underlying ocular disease being studied.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.