FDA label 45f6e6f9-58b6-41a9-a8ba-9bfc560ca47a

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
86137340-55c3-4ed2-8166-2fb2779ca759
SPL ID
45f6e6f9-58b6-41a9-a8ba-9bfc560ca47a
Version
7
Effective date
2021-04-15
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 02:33:38

Adverse reactions cross-check#

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

adverse reactions

ADVERSE EFFECTS Metabolic alkalosis and/or hypokalaemia may ensue as a result of prolonged use or over correction of the bicarbonate deficit, especially in patients with impaired renal function. (see OVERDOSAGE ) Metabolic alkalosis may be accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability or tetany. Hypernatraemia has been reported with sodium bicarbonate use, especially in patients with renal disease. Hyperosmolality has also been associated with sodium bicarbonate use. Accidental extravasation of intravenous hypertonic solutions of sodium bicarbonate has been reported to cause chemical cellulitis, with tissue necrosis, tissue calcification, ulceration or sloughing at the site of infiltration. Prompt elevation of the part, warmth and local injection of lignocaine or hyaluronidase are recommended to prevent sloughing of extravasated intravenous infusions. Hyperirritability or tetany may occur, caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from the pH changes. Cerebral oedema has occurred with sodium bicarbonate use and a possibility of intracranial haemorrhage exists. Hypercapnia has occurred in patients receiving sodium bicarbonate and with fixed ventilation.

Reported adverse events (FAERS/openFDA)#

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