Proair Digihaler Side Effects Center

Last updated on RxList: 2/9/2022
Proair Digihaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Proair Digihaler?

Proair Digihaler (albuterol sulfate) contains a beta2-adrenergic agonist indicated for treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients 4 years of age and older.

What Are Side Effects of Proair Digihaler?

Common side effects of Proair Digihaler include:

Dosage for Proair Digihaler

ProAir Digihaler is a dry powder inhaler that meters 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) from the device reservoir and delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation. The inhaler is supplied for 200 inhalation doses.

What Drugs, Substances, or Supplements Interact with Proair Digihaler?

Proair Digihaler may interact with other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs, beta-blockers, diuretics or non-potassium sparing diuretics, digoxin, monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants. Tell your doctor all medications and supplements you use.

Proair Digihaler During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Proair Digihaler; it is unknown how it would affect a fetus. It is unknown if the medication in Proair Digihaler passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Proair Digihaler (albuterol sulfate) Inhalation Powder, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Proair Digihaler Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
  • severe headache, pounding in your neck or ears;
  • pain or burning when you urinate;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • low potassium--leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • chest pain, fast or pounding heartbeats;
  • upset stomach, vomiting;
  • painful urination;
  • dizziness;
  • feeling shaky or nervous;
  • headache, back pain, body aches; or
  • cough, sore throat, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Proair Digihaler (Albuterol Sulfate Inhalation Powder)

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Proair Digihaler Professional Information

SIDE EFFECTS

Use of ProAir Digihaler may be associated with the following:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

A total of 1289 subjects were treated with albuterol sulfate inhalation powder (ProAir RespiClick hereafter referred to as albuterol sulfate MDPI) during the clinical development program. The most common adverse reactions (≥1% and > placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults And Adolescents 12 Years Of Age And Older

The adverse reaction information presented in Table 1 below concerning albuterol sulfate MDPI is derived from the 12-week blinded treatment period of three studies which compared albuterol sulfate MDPI 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to 76 years of age.

Table 1: Adverse Reactions Experienced by Greater Than or Equal to 1.0% of Adult and Adolescent Patients in the Albuterol sulfate MDPI Group and Greater Than Placebo in three 12-Week Clinical Trials1

Preferred Term Number (%) of patients
Albuterol sulfate MDPI 180 mcg QID
N=321
Placebo
N=333
Back pain 6 (2%) 4 (1%)
Pain 5 (2%) 2 (<1%)
Gastroenteritis viral 4 (1%) 3 (<1%)
Sinus headache 4 (1%) 3 (<1%)
Urinary tract infection 4 (1%) 3 (<1%)
1 This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of greater than or equal to 1.0% in the albuterol sulfate MDPI group and greater than placebo.

In a long-term study of 168 patients treated with albuterol sulfate MDPI for up to 52 weeks (including a 12-week double-blind period), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.

In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverse events.

Pediatric Patients 4 To 11 Years Of Age

The adverse reaction information presented in Table 2 below concerning albuterol sulfate MDPI is derived from a 3-week pediatric clinical trial which compared albuterol sulfate MDPI 180 mcg four times daily with a double-blinded matched placebo in 185 asthmatic patients 4 to 11 years of age.

Table 2: Adverse Reactions Experienced by Greater Than or Equal to 2.0% of Patients 4 to 11 Years of Age in the Albuterol sulfate MDPI Group and Greater Than Placebo in the 3 Week Trial

Preferred Term Number (%) of patients
Albuterol sulfate MDPI 180 mcg QID
N=93
Placebo
N=92
Nasopharyngitis 2 (2%) 1 (1%)
Oropharyngeal pain 2 (2%) 1 (1%)
Vomiting 3 (3%) 1 (1%)

Postmarketing Experience

In addition to the adverse reactions reported from clinical trials with albuterol sulfate MDPI, the following adverse events have been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (potentially fatal), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

DRUG INTERACTIONS

Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

Beta-Blockers

Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma. In this setting, consider cardioselective beta-blockers, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.

Digoxin

Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler.

Monoamine Oxidase Inhibitors Or Tricyclic Antidepressants

ProAir Digihaler should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

Read the entire FDA prescribing information for Proair Digihaler (Albuterol Sulfate Inhalation Powder)

© Proair Digihaler Patient Information is supplied by Cerner Multum, Inc. and Proair Digihaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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