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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 56e4f2d6-1aa4-4a2d-ace7-71c50a5cef95 | id | |
| spl set id | 394d3238-f763-4f67-bb9d-08751ec6ed31 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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instituted, since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn.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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.