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Tornalate Side Effects

Generic name: bitolterol

Note: This document contains side effect information about bitolterol. Some dosage forms listed on this page may not apply to the brand name Tornalate.

Applies to bitolterol: inhalation aerosol, inhalation solution.


It is very important that you use your bitolterol inhaler or nebulizer properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler and nebulizer use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Stop using bitolterol (the active ingredient contained in Tornalate) and seek emergency medical attention if you experience any of the following serious side effects:

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

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 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]

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]


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


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


1. (2022) "Product Information. Tornalate (bitolterol)." Apothecon Inc

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

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

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

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.