FDA label 4984db98-48c3-4a2e-b39a-c7475bb2f233

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
da8a8a19-ac1b-4160-aac4-c4c57598eb5d
SPL ID
4984db98-48c3-4a2e-b39a-c7475bb2f233
Version
6
Effective date
2022-09-14
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:38

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. There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma. This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD ® Solution. Central nervous system disturbances have also been reported. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs. Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD ® instillation.

Reported adverse events (FAERS/openFDA)#

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