FDA label 7a0120e6-e888-44c9-98ef-d0250888f446

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
a3765689-ef84-4244-8645-57a24f7e30d3
SPL ID
7a0120e6-e888-44c9-98ef-d0250888f446
Version
5
Effective date
2019-10-07
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:34:08

Boxed warning cross-check#

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boxed warning

IMPORTANT - Antidote for Peripheral Ischemia - To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of saline solution containing 5 to 10 mg of Regitine ® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Warnings cross-check#

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warnings

WARNINGS Do NOT add DOPAMINE to any alkaline diluent solution, since the drug is inactivated in alkaline solution. Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE will require substantially reduced dosage. See Drug Interactions , below. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown, and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Cardiovascular System ventricular arrhythmia (at very high doses) ectopic beats tachycardia anginal pain palpitation cardiac conduction abnormalities widened QRS complex bradycardia hypotension hypertension vasoconstriction Respiratory System Dyspnea Gastrointestinal System nausea vomiting Metabolic/Nutritional System Azotemia Central Nervous System headache anxiety Dermatological System Piloerection Other Gangrene of the extremities has occurred when moderate to high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine HCl. A few cases of peripheral cyanosis have been reported.

Reported adverse events (FAERS/openFDA)#

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