FDA label 9870dbfc-91f0-4a22-a740-fcc42824ab56

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
f9e3d9fc-59fe-453c-a799-6f4d3eacaf36
SPL ID
9870dbfc-91f0-4a22-a740-fcc42824ab56
Version
3
Effective date
2011-02-07
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:24

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS KEEP RESUSCITATIVE AND ENDOTRACHEAL INTUBATION EQUIPMENT AND OXYGEN READILY AVAILABLE. MAINTAIN PATENCY OF THE AIRWAY AT ALL TIMES. This drug should be administered only by persons qualified in the use of intravenous anesthetics. Avoid extravasation or intra-arterial injection.

warnings

WARNINGS Intravenous administration of Sterile Water for Injection, USP without a solute may result in hemolysis. Use aseptic technique for preparing Pentothal solutions during withdrawal from reconstituted single -use containers. Administer only clear reconstituted solutions. Use within 24 hours after reconstitution. Discard unused portions.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions include respiratory depression, myocardial depression, cardiac arrhythmias, prolonged somnolence and recovery, sneezing, coughing, bronchospasm, laryngospasm and shivering. Anaphylactic and anaphylactoid reactions to Pentothal (Thiopental Sodium for Injection) have been reported. Symptoms, e.g., urticaria, bronchospasm, vasodilation and edema should be managed by conventional means. Rarely, immune hemolytic anemia with renal failure and radial nerve palsy have been reported.

adverse reactions

ADVERSE REACTIONS Reactions which may occur because of the diluent, technique of preparation or mixing, or administration of reconstituted solutions of Pentothal include febrile response or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the injection, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of unused solution (or the used container or syringe) for examination if deemed necessary.

Reported adverse events (FAERS/openFDA)#

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