FDA label 56e4f2d6-1aa4-4a2d-ace7-71c50a5cef95

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
394d3238-f763-4f67-bb9d-08751ec6ed31
SPL ID
56e4f2d6-1aa4-4a2d-ace7-71c50a5cef95
Version
2
Effective date
2016-08-02
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:53

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Excessive use of an adrenergic aerosol should be discouraged, as it may lose effectiveness. Occasional patients have been reported to develop severe paradoxical airway resistance with repeated, excessive use of isoproterenol inhalation preparations (see ADVERSE REACTIONS ). The cause of this is unknown. It is advisable that in such instances the use of this preparation be discontinued immediately and alternative therapy instituted, since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn. Deaths have been reported following excessive use of isoproterenol inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several instances (see ADVERSE REACTIONS ).

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The following adverse effects, listed by organ system in decreasing frequency have been associated with the use of MEDIHALER-ISO and are similar to those produced by other sympathomimetic agents: Cardiovascular: Palpitation, tachycardia, coronary insufficiency, flushing of the skin, blood pressure changes, cardiac arrhythmias, anginal pain, cardiac arrest. Pulmonary: Paradoxical airway resistance (see WARNINGS ), rebound bronchospasm. Central Nervous System: Headache, tremor, vertigo, central excitation, insomnia. Gastrointestinal: Nausea.

Reported adverse events (FAERS/openFDA)#

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