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FDA label ff190c53-1505-4815-bd38-9ecf57f2c91f

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
478a9556-861f-457f-b571-c5af8b9f88ec
SPL ID
ff190c53-1505-4815-bd38-9ecf57f2c91f
Version
1
Effective date
2013-04-01
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 02:04:38

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 26 controlled clinical trials with 496 patients treated with metaproterenol sulfate tablets: Metaproterenol Sulfate Tablets Incidence of Adverse Events Reported Among 496 Patients Treated in 26 Controlled Clinical Trials ADVERSE EXPERIENCE INCIDENCE Number of Patients % Cardiovascular Chest Pain 1 0.2 Edema 1 0.2 Hypertension 2 0.4 Palpitations 19 3.8 Tachycardia 85 17.1 Central Nervous System Dizziness 12 2.4 Drowsiness 3 0.6 Fatigue 7 1.4 Headache 35 7.0 Insomnia 9 1.8 Nervousness 100 20.2 Sensory disturbances 1 0.2 Syncope 2 0.4 Weakness 1 0.2 Dermatological Diaphoresis 1 0.2 Hives 1 0.2 Pruritus 2 0.4 Gastrointestinal Appetite changes 2 0.4 Diarrhea 6 1.2 Gastrointestinal distress 15 3.0 Nausea 18 3.6 Vomiting 4 0.8 Musculoskeletal Pain 1 0.2 Spasms 1 0.2 Tremor 84 16.9 Ophthalmological Blurred vision 1 0.2 Oro-Otolaryngeal Dry mouth/throat 2 0.4 Laryngeal changes 1 0.2 Bad taste 4 0.8 Respiratory Asthma exacerbation 10 2.0 Coughing 1 0.2 Other Chatty 1 0.2 Chills 1 0.2 Clonus noted on flexing foot 1 0.2 Feverish 2 0.4 Flu Symptoms 1 0.2 Facial and finger puffiness 1 0.2

adverse reactions table

<table ID="inv-6f1db564-e4ab-4560-9991-dbb0ae2dc096" frame="void"> <caption ID="inv-4d5cc4fc-19bf-4b18-a77d-700e323e5317">Metaproterenol Sulfate Tablets Incidence of Adverse Events Reported Among 496 Patients Treated in 26 Controlled Clinical Trials</caption> <col width="216px"/> <col width="172px"/> <col width="88px"/> <tbody> <tr> <td styleCode="Botrule"> <content styleCode="bold">ADVERSE EXPERIENCE </content> </td> <td align="center" colspan="2" styleCode="Botrule"> <content styleCode="bold">INCIDENCE</content> </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> </content> </td> <td align="center" styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Number of Patients</content> </content> </td> <td align="center" styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">%</content> </content> </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Cardiovascular </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Chest Pain </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Edema </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Hypertension</td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Palpitations </td> <td align="center" styleCode="Botrule"> 19 </td> <td align="center" styleCode="Botrule"> 3.8 </td> </tr> <tr> <td styleCode="Botrule"> Tachycardia </td> <td align="center" styleCode="Botrule"> 85 </td> <td align="center" styleCode="Botrule"> 17.1 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Central Nervous System </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Dizziness </td> <td align="center" styleCode="Botrule"> 12 </td> <td align="center" styleCode="Botrule"> 2.4 </td> </tr> <tr> <td styleCode="Botrule"> Drowsiness </td> <td align="center" styleCode="Botrule"> 3 </td> <td align="center" styleCode="Botrule"> 0.6 </td> </tr> <tr> <td styleCode="Botrule"> Fatigue </td> <td align="center" styleCode="Botrule"> 7 </td> <td align="center" styleCode="Botrule"> 1.4 </td> </tr> <tr> <td styleCode="Botrule"> Headache </td> <td align="center" styleCode="Botrule"> 35 </td> <td align="center" styleCode="Botrule"> 7.0 </td> </tr> <tr> <td styleCode="Botrule"> Insomnia </td> <td align="center" styleCode="Botrule"> 9 </td> <td align="center" styleCode="Botrule"> 1.8 </td> </tr> <tr> <td styleCode="Botrule"> Nervousness </td> <td align="center" styleCode="Botrule"> 100 </td> <td align="center" styleCode="Botrule"> 20.2 </td> </tr> <tr> <td styleCode="Botrule"> Sensory disturbances </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Syncope </td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Weakness </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Dermatological </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Diaphoresis </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Hives </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Pruritus </td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Gastrointestinal </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Appetite changes </td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Diarrhea </td> <td align="center" styleCode="Botrule"> 6 </td> <td align="center" styleCode="Botrule"> 1.2 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Gastrointestinal distress </content> </content> </td> <td align="center" styleCode="Botrule"> 15 </td> <td align="center" styleCode="Botrule"> 3.0 </td> </tr> <tr> <td styleCode="Botrule"> Nausea </td> <td align="center" styleCode="Botrule"> 18 </td> <td align="center" styleCode="Botrule"> 3.6 </td> </tr> <tr> <td styleCode="Botrule"> Vomiting </td> <td align="center" styleCode="Botrule"> 4 </td> <td align="center" styleCode="Botrule"> 0.8 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Musculoskeletal </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Pain </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Spasms </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Tremor </td> <td align="center" styleCode="Botrule"> 84 </td> <td align="center" styleCode="Botrule"> 16.9 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Ophthalmological </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Blurred vision </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Oro-Otolaryngeal </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Dry mouth/throat </td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Laryngeal changes </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Bad taste </td> <td align="center" styleCode="Botrule"> 4 </td> <td align="center" styleCode="Botrule"> 0.8 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Respiratory </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Asthma exacerbation </td> <td align="center" styleCode="Botrule"> 10 </td> <td align="center" styleCode="Botrule"> 2.0 </td> </tr> <tr> <td styleCode="Botrule"> Coughing </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> <content styleCode="bold"> <content styleCode="underline">Other </content> </content> </td> <td align="center" styleCode="Botrule"> </td> <td align="center" styleCode="Botrule"> </td> </tr> <tr> <td styleCode="Botrule"> Chatty </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Chills </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Clonus noted on flexing foot </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Botrule"> Feverish </td> <td align="center" styleCode="Botrule"> 2 </td> <td align="center" styleCode="Botrule"> 0.4 </td> </tr> <tr> <td styleCode="Botrule"> Flu Symptoms </td> <td align="center" styleCode="Botrule"> 1 </td> <td align="center" styleCode="Botrule"> 0.2 </td> </tr> <tr> <td styleCode="Rrule"> Facial and finger puffiness </td> <td align="center" styleCode="Rrule"> 1 </td> <td align="center"> 0.2 </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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