FDA label 40aab76c-82cc-48fd-917d-d044fc90afb9

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
91efdaa9-9213-46d1-ab1f-d11e675a6f4a
SPL ID
40aab76c-82cc-48fd-917d-d044fc90afb9
Version
2
Effective date
2011-06-01
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:00:09

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 occurrence 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 causal 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. Vasodilan (isoxsuprine HCl tablets, USP) is neither approved nor recommended for use in the treatment of premature labor.

Reported adverse events (FAERS/openFDA)#

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