Home FDA labels e6b84a6a-ff6c-4b47-a01a-ee74701b6629 FDA label e6b84a6a-ff6c-4b47-a01a-ee74701b6629 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 07315965-0be6-4c18-a8b9-25821a3732e2
SPL ID e6b84a6a-ff6c-4b47-a01a-ee74701b6629
Version 2
Effective date 2016-08-02
Source export date 2026-10-12
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:06:42 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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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instituted, since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn.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 ).
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Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions ADVERSE REACTIONS The following adverse effects, listed by organ system in decreasing frequency have been associated with the use of DUO-MEDIHALER and are similar to those produced by other sympathomimetic agents: Isoproterenol Phenylephrine Cardio- palpitation bradycardia vascular: tachycardia decreased cardiac coronary output insufficiency blanching of skin flushing of skin peripheral and blood pressure visceral vaso- changes constriction cardiac arrhythmias cardiac cardiac arrest irregularities anginal pain anginal pain Isoproterenol Phenylephrine Pulmonary: paradoxical airway respiratory resistance distress rebound broncho- spasm Central Nerv- headache tremor ous System: tremor dizziness vertigo central excitation central excitation pilomotor insomnia response Gastro- nausea Intestinal:
adverse reactions table <table width="100%"> <col align="left" width="28.200%"/> <col align="left" width="35.900%"/> <col align="left" width="35.900%"/> <tbody> <tr> <td align="left" valign="top"/> <td align="left" valign="top"> <content styleCode="underline">Isoproterenol</content> </td> <td align="left" valign="top"> <content styleCode="underline">Phenylephrine</content> </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="underline">Cardio-</content> </td> <td align="left" valign="top">palpitation</td> <td align="left" valign="top">bradycardia</td> </tr> <tr> <td align="left" valign="top"> <content styleCode="underline">vascular:</content> </td> <td align="left" valign="top">tachycardia</td> <td align="left" valign="top">decreased cardiac</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">coronary</td> <td align="left" valign="top"> output</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top"> insufficiency</td> <td align="left" valign="top">blanching of skin</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">flushing of skin</td> <td align="left" valign="top">peripheral and</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">blood pressure</td> <td align="left" valign="top">visceral vaso-</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top"> changes</td> <td align="left" valign="top"> constriction</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">cardiac arrhythmias</td> <td align="left" valign="top">cardiac</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">cardiac arrest</td> <td align="left" valign="top"> irregularities</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">anginal pain</td> <td align="left" valign="top">anginal pain</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top"> <content styleCode="underline">Isoproterenol</content> </td> <td align="left" valign="top"> <content styleCode="underline">Phenylephrine</content> </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="underline">Pulmonary:</content> </td> <td align="left" valign="top">paradoxical airway</td> <td align="left" valign="top">respiratory</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top"> resistance</td> <td align="left" valign="top"> distress</td> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">rebound broncho-</td> <td align="left" valign="top"/> </tr> <tr> <td align="left" valign="top"/> <td align="left" valign="top">spasm</td> <td align="left" valign="top"/> </tr> <tr> <td align="left" valign="top"> <content styleCode="underline">Central Nerv-</content> </td> <td align="left" valign="top">headache</td> <td align="left" valign="top">tremor</td> </tr> <tr> <td align="justify" valign="top"> <content styleCode="underline">ous System:</content> </td> <td align="left" valign="top">tremor</td> <td align="left" valign="top">dizziness</td> </tr> <tr> <td align="justify" valign="top"/> <td align="left" valign="top">vertigo</td> <td align="left" valign="top">central excitation</td> </tr> <tr> <td align="justify" valign="top"/> <td align="left" valign="top">central excitation</td> <td align="left" valign="top">pilomotor</td> </tr> <tr> <td align="justify" valign="top"/> <td align="left" valign="top">insomnia</td> <td align="left" valign="top"> response</td> </tr> <tr> <td align="justify" valign="top"> <content styleCode="underline">Gastro-</content> </td> <td align="left" valign="top">nausea</td> <td align="left" valign="top"/> </tr> <tr> <td align="justify" valign="top"> <content styleCode="underline">Intestinal:</content> </td> <td align="left" valign="top"/> <td align="left" valign="top"/> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.