FDA label 0fc1a7e2-40f3-4d10-ad45-fa1404652b26

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
66eb4b4d-2388-49d3-8ffa-0b9bca75a28e
SPL ID
0fc1a7e2-40f3-4d10-ad45-fa1404652b26
Version
5
Effective date
2016-11-07
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:32

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Metaproterenol, like other beta adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions are similar to those noted with other sympathomimetic agents. The following table of adverse experiences is derived from 44 clinical trials involving 1,120 patients treated with metaproterenol sulfate syrup: Metaproterenol Sulfate Syrup Incidence of Adverse Events Occurring in at least 1% of Patients Adverse Experience Incidence Number of Patients % Cardiovascular Tachycardia 68 6.1 Central Nervous System Headache 12 1.1 Nervousness 54 4.8 Gastrointestinal Nausea 15 1.3 Musculoskeletal Tremor 18 1.6

adverse reactions table

<table> <caption>Metaproterenol Sulfate Syrup Incidence of Adverse Events Occurring in at least 1% of Patients</caption> <col/> <col/> <col/> <tbody> <tr> <td> <content styleCode="bold">Adverse Experience</content> </td> <td> </td> <td> <content styleCode="bold">Incidence</content> </td> </tr> <tr> <td> </td> <td> Number of Patients </td> <td> <content styleCode="bold">%</content> </td> </tr> <tr> <td> <content styleCode="underline">Cardiovascular</content> </td> <td> </td> <td> </td> </tr> <tr> <td> Tachycardia </td> <td> 68 </td> <td> 6.1 </td> </tr> <tr> <td> <content styleCode="underline">Central Nervous System</content> </td> <td> </td> <td> </td> </tr> <tr> <td> Headache </td> <td> 12 </td> <td> 1.1 </td> </tr> <tr> <td> Nervousness </td> <td> 54 </td> <td> 4.8 </td> </tr> <tr> <td> <content styleCode="underline">Gastrointestinal</content> </td> <td> </td> <td> </td> </tr> <tr> <td> Nausea </td> <td> 15 </td> <td> 1.3 </td> </tr> <tr> <td> <content styleCode="underline">Musculoskeletal</content> </td> <td> </td> <td> </td> </tr> <tr> <td> Tremor </td> <td> 18 </td> <td> 1.6 </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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