FDA label 32ef5671-eef2-47a0-9c0a-90e3efab0681

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
e6582e24-9414-43b8-ac6f-b1422e3197cf
SPL ID
32ef5671-eef2-47a0-9c0a-90e3efab0681
Version
10
Effective date
2021-08-28
Source export date
2026-08-17
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/860dc0eef34653a2a2dab2761771be9cda8410b7a1f078032b37381cbdbb4107/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:33:18

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS On rare occasion, oral administration of the drug has been associated in time with the occurrences of hypotension, tachycardia, chest pain, nausea, vomiting, dizziness, abdominal distress, and severe rash. If rash appears, the drug should be discontinued. Although available evidence suggests a temporal association of these reactions with isoxsuprine, a casual relationship can be neither confirmed nor refuted. β-Adrenergic receptor stimulants such as isoxsuprine hydrochloride have been used to inhibit pre-term labor. Maternal and fetal tachycardia may occur under such use. Hypocalcemia, hypoglycemia, hypotension and ileus have been reported to occur in infants whose mothers received isoxsuprine. Pulmonary edema has been reported in mothers treated with β-stimulants. Isoxsuprine HCl tablets, USP is neither approved nor recommended for use in the treatment of premature labor.