Bitolterol Side Effects

Not all side effects for bitolterol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bitolterol: inhalation aerosol, inhalation solution

Stop using bitolterol and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

  • chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use bitolterol inhalation and talk to your doctor if you experience

  • headache, dizziness, lightheadedness, or insomnia;

  • tremor or nervousness;

  • sweating;

  • nausea, vomiting, or diarrhea; or

  • dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to bitolterol: inhalation aerosol, inhalation solution

Cardiovascular

Tachycardia has been reported in 3.7% of patients, palpitations in 3.1% of patients, and irregular pulse in 1.2% of patients. Higher dosages of bitolterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension.[Ref]

Cardiovascular side effects have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Changes in blood pressure, both increases and decreases, have been reported. Higher dosages have rarely aggravated angina and myocardial ischemia or caused atrial or ventricular arrhythmias.[Ref]

Metabolic

Metabolic side effects have rarely included hyperglycemia and hyperthyroidism.[Ref]

Nervous system

Nervous system side effects have included tremors (26.6%), nervousness (11.1%), headache (8.4%), lightheadedness (6.8%), dizziness (4%), paresthesia (1.5%), and somnolence (1.2%).[Ref]

The incidence of tremors has been reported to decrease from 22% to 9% during the third month of therapy with bitolterol.[Ref]

Respiratory

Respiratory side effects have included coughing (2.5%), bronchospasm (1.5%), chest discomfort (1.5%), and rhinitis (1.5%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included throat irritation (2.5%), mouth irritation (1.9%), and nausea (1.9%).[Ref]

References

1. "Product Information. Tornalate Metered Dose (bitolterol)." Dura Pharmaceuticals, San Diego, CA.

2. Nathan RA, Bronsky EA, Dockhorn RJ, Kemp JP "Multicenter dose-ranging study of bitolterol mesylate solution for nebulization in children with asthma." Ann Allergy 72 (1994): 209-16

3. Pinnas JL, Bhatt BD, Campbell SC, Kemp JP, Tinkelman DG "Dose-response study of nebulized bitolterol mesylate solution in asthmatic patients." Chest 91 (1987): 533-9

4. Bierman CW, Kemp JP, Nathan RA "Efficacy and safety of inhaled bitolterol mesylate via metered-dose inhaler in children with asthma." Ann Allergy Asthma Immunol 76 (1996): 27-35

5. "Bitolterol--a new bronchodilator." Med Lett Drugs Ther 27 (1985): 46-7

6. Walker SB, Bierman CW, Pierson WE, Shapiro GG, Furukawa CT, Mingo TS "Bitolterol mesylate in exercise-induced asthma." J Allergy Clin Immunol 77 (1986): 32-6

7. Orgel HA, Kemp JP, Tinkelman DG, Webb DR Jr "Bitolterol and albuterol metered-dose aerosols: comparison of two long-acting beta 2-adrenergic bronchodilators for treatment o asthma." J Allergy Clin Immunol 75 (1985): 55-62

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