FDA.reportPublic FDA data

Tropicamide

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)

Brand name
Tropicamide
Generic name
TROPICAMIDE
Manufacturer
Bausch & Lomb Incorporated
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
892b78c8-36bc-47d3-850e-502899b48fb9
SPL ID
f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755
Version
9
Effective date
2023-09-01
Source export date
2026-08-08
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/c371bcf53af83126908f941c4bb6f83aeaa6e2ef3749f9f7be6c7a3681e3b333/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:21:40
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

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warnings

WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Ocular Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.