FDA label 1e7c05e6-423b-87f3-e063-6294a90ac380

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
696bf471-98df-4db4-9465-c2189c9d3e65
SPL ID
1e7c05e6-423b-87f3-e063-6294a90ac380
Version
2
Effective date
2024-07-30
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 05:17:56

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Use of sympathomimetic amines with monoamine oxidase inhibitors or tricyclic antidepressants may result in potentiation of the pressor effect. (See PRECAUTIONS, Drug Interactions.) Metaraminol bitartrate injection 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 sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Sympathomimetic amines, including metaraminol bitartrate injection, may cause sinus or ventricular tachycardia, or other arrhythmias, especially in patients with myocardial infarction. (See PRECAUTIONS.) In patients with a history of malaria, these compounds may provoke a relapse. Abscess formation, tissue necrosis, or sloughing rarely may follow the use of metaraminol bitartrate injection. In choosing the site of injection, it is important to avoid those areas recognized as not suitable for use of any pressor agent and to discontinue the infusion immediately if infiltration or thrombosis occurs. Although the physician may be forced by the urgent nature of the patient's condition to choose injection sites that are not recognized as suitable, he should, when possible, use the preferred areas of injection. The larger veins of the antecubital fossa or the thigh are preferred to veins in the dorsum of the hand or ankle veins, particularly in patients with peripheral vascular disease, diabetes mellitus, Buerger's disease, or conditions with coexistent hypercoagulability.

Reported adverse events (FAERS/openFDA)#

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