FDA label 7df421a4-9129-4d22-8c53-37119afa8ee0
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
- SPL set ID
- 4dba65c7-d0e3-493c-875f-1e1a27ad7a33
- SPL ID
- 7df421a4-9129-4d22-8c53-37119afa8ee0
- Version
- 3
- Effective date
- 2017-03-22
- Source export date
- 2026-10-12
- 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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:30:09
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 7df421a4-9129-4d22-8c53-37119afa8ee0 | id | |
| spl set id | 4dba65c7-d0e3-493c-875f-1e1a27ad7a33 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS EVERY EFFORT SHOULD BE MADE TO AVOID POSSIBLE INADVERTENT INTRAVASCULAR ADMINISTRATION THROUGH APPROPRIATE SELECTION OF INJECTION SITE SUCH AS THIGH OR DELTOID. DO NOT INJECT INTO BUTTOCK. Monitoring with an electrocardiograph is recommended when lidocaine hydrochloride is administered by the intramuscular route. In emergency situations when a ventricular rhythm disorder is suspected and electrocardiographic equipment is not available, a single dose may be administered when the physician in attendance has determined that the potential benefits outweigh the possible risks. If possible, emergency resuscitative equipment and drugs should be immediately available to manage potential adverse reactions involving the cardiovascular, respiratory, or central nervous system. Occasional acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with atrial fibrillation.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following types of systemic reactions have been reported with lidocaine hydrochloride administration: Central Nervous System: light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred or double vision; vomiting; sensations of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest. Cardiovascular System: hypotension; bradycardia; cardiovascular collapse and cardiac arrest. Allergic reactions may occur but are infrequent. There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Soreness at the injection site following intramuscular injection has occasionally been reported. MANAGEMENT OF ADVERSE REACTIONS In the case of severe reaction, do not continue or repeat administration of the drug. Institute emergency resuscitative procedures including maintenance of patent airway and cardiopulmonary resuscitation, if required. For severe convulsions, parenteral administration of a rapidly acting anticonvulsant may be used by persons appropriately trained in the use of those drugs and the management of the cardiovascular and respiratory depression which may result. Resuscitative equipment should be available.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.