FDA label c9a92c4b-a806-481f-9809-8acd50f41363

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
8b0fde24-9549-11cf-e053-2a95a90a9338
SPL ID
c9a92c4b-a806-481f-9809-8acd50f41363
Version
3
Effective date
2024-01-09
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:57:17

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING: For Topical Ophthalmic Use Only. NOT FOR INJECTION. Do not touch the dropper up to lids or any surface, as this may contaminate the solution. Dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once a week.

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: In controlled studies the most frequent reaction to dapiprazole was conjunctival injection lasting 20 minutes in over 80% of patients. Burning on instillation of dapiprazole hydrochloride ophthalmic solution was reported in approximately half of all patients. Reactions occurring in 10% to 40% of patients included ptosis, lid erythema, lid edema, chemosis, itching, punctate keratitis, corneal edema, browache, photophobia and headaches. Other reactions reported less frequently included dryness of eyes, tearing and blurring of vision.

Reported adverse events (FAERS/openFDA)#

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