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Maxair Autohaler Side Effects

Please note - some side effects for Maxair Autohaler may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Maxair Autohaler - for the Consumer

Maxair Autohaler

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Maxair Autohaler:

Cough; dizziness; headache; nausea; nervousness; tremor.

Seek medical attention right away if any of these SEVERE side effects occur when using Maxair Autohaler:

Severe allergic reactions (rash; hives; itching; wheezing; increased difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; fainting; fast or irregular heartbeat; muscle weakness or cramps; new or worsened trouble breathing; severe or persistent headache or dizziness; tightness in the chest; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Maxair Autohaler Side Effects - for the Professional

Maxair Autohaler

The following rates of adverse reactions to pirbuterol are based on single- and multiple-dose clinical trials involving 761 patients, 400 of whom received multiple doses (mean duration of treatment was 2.5 months and maximum was 19 months).

The following were the adverse reactions reported more frequently than 1 in 100 patients:

CNS: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%).

Cardiovascular: palpitations (1.7%), tachycardia (1.2%).

Respiratory: cough (1.2%).

Gastrointestinal: nausea (1.7%).

The following adverse reactions occurred less frequently than 1 in 100 patients and there may be a causal relationship with pirbuterol:

CNS: depression, anxiety, confusion, insomnia, weakness, hyperkinesia, syncope.

Cardiovascular: hypotension, skipped beats, chest pain.

Gastrointestinal: dry mouth, glossitis, abdominal pain/cramps, anorexia, diarrhea, stomatitis, nausea and vomiting.

Ear, Nose and Throat: smell/taste changes, sore throat.

Dermatological: rash, pruritus.

Other: numbness in extremities, alopecia, bruising, fatigue, edema, weight gain, flushing.

Other adverse reactions were reported with a frequency of less than 1 in 100 patients but a causal relationship between pirbuterol and the reaction could not be determined: migraine, productive cough, wheezing, and dermatitis.

The following rates of adverse reactions during three-month controlled clinical trials involving 310 patients are noted. The table does not include mild reactions.

PERCENT OF PATIENTS WITH MODERATE TO SEVERE ADVERSE REACTIONS
Reaction Pirbuterol Metaproterenol
N=157 N=153
Central Nervous System
tremors 1.3% 3.3%
nervousness 4.5% 2.6%
headache 1.3% 2.0%
weakness .0% 1.3%
drowsiness .0% 0.7%
dizziness 0.6% .0%
Cardiovascular
palpitations 1.3% 1.3%
tachycardia 1.3% 2.0%
Respiratory
chest pain/tightness 1.3% .0%
cough .0% 0.7%
Gastrointestinal
nausea 1.3% 2.0%
diarrhea 1.3% 0.7%
dry mouth 1.3% 1.3%
vomiting .0% 0.7%
Dermatological
skin reaction .0% 0.7%
rash .0% 1.3%
Other
bruising 0.6% .0%
smell/taste change 0.6% .0%
backache .0% 0.7%
fatigue .0% 0.7%
hoarseness .0% 0.7%
nasal congestion .0% 0.7%

Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, cross-over study in 57 patients, showed no observations or findings considered clinically significant, or related to drug administration. Most electrocardiographic observations, obtained during a randomized, double-blind, cross-over study in 40 patients, were judged not clinically significant or related to drug administration. One patient was noted to have some changes on the one hour postdose electrocardiogram consisting of ST and T wave abnormality suggesting possible inferior ischemia. This abnormality was not observed on the predose or the six hours postdose ECG. A treadmill was subsequently performed and all the findings were normal.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Blood pressure may increase or decrease. Higher doses may rarely aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias.

Although most studies have not revealed a significant effect of pirbuterol on blood pressure or heart rate, anecdotally significant increases have been noted. Aggravation of angina may be due to tachycardia produced by pirbuterol. Supraventricular premature beats and ventricular tachycardia have also been reported. Higher doses of pirbuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.

Musculoskeletal

Musculoskeletal side effects have included tremors, especially at higher doses.

Gastrointestinal

Gastrointestinal side effects have included nausea, dry mouth, and diarrhea.

Metabolic

Metabolic side effects have included hypokalemia and, less commonly, hyperglycemia.

Nervous system

Nervous system side effects have included nervousness, dizziness, insomnia, and headache.

Respiratory

Respiratory side effects have included cough. Rare instances of paradoxical bronchoconstriction have been associated with the use of pirbuterol.

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