Theolair Side Effects
Generic name: theophylline
Note: This document contains side effect information about theophylline. Some of the dosage forms listed on this page may not apply to the brand name Theolair.
Some side effects of Theolair may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to theophylline: oral capsule extended release, oral elixir, oral solution, oral tablet extended release
Get emergency medical help if you have any of these signs of an allergic reaction while taking theophylline (the active ingredient contained in Theolair) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using theophylline and call your doctor at once if you have a serious side effect such as:
severe or continued vomiting;
rapid or uneven heartbeats;
confusion, tremors or shaking;
nausea and vomiting, severe headache, rapid heart rate;
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).
Less serious side effects of theophylline may include:
stomach pain, diarrhea, upset stomach;
sleep problems (insomnia); or
feeling restless, nervous, or irritable;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to theophylline: compounding powder, intravenous solution, oral capsule, oral capsule extended release, oral elixir, oral solution, oral syrup, oral tablet, oral tablet extended release
The majority of side effects have been dependent on the serum concentration. Generally, serum concentrations of theophylline (the active ingredient contained in Theolair) ranging from 10 to 20 mcg/mL are considered therapeutic, and serum concentrations greater than 20 mcg/mL are associated with greater toxicity.
There are several factors which may predispose a patient to higher serum concentrations and, thus, toxicity. These factors may include increased age, concomitant drugs which reduce the clearance of theophylline, hypothyroidism, congestive heart failure, liver disease, renal failure, and alterations in smoking habits. One series of patients with theophylline intoxication had recent upper respiratory tract infections.
The nature of acute toxicity of theophylline differs from chronic toxicity. Acute overdose is associated with higher theophylline concentrations and younger patients. In acute overdose the severity of toxicity is correlated with peak serum concentrations. Chronic overdosage is seen more commonly in older patients, and severe toxicity may occur with serum concentrations which are much lower than those seen in severe acute toxicity. In these patients, age is a predictor of severe toxicity.
Gastrointestinal side effects have included anorexia, nausea, vomiting, and abdominal pain. Theophylline (the active ingredient contained in Theolair) may also cause locally-mediated gastrointestinal upset.
Nervous system side effects have included generalized seizures, most commonly in patients with elevated serum concentrations, although seizures have occurred at therapeutic concentrations. Theophylline (the active ingredient contained in Theolair) may also cause nervousness and tremor at therapeutic dosages, which become worse as serum concentrations increase.
The mechanism of theophylline-induced seizures has not been determined. Seizures are generally focal with secondary generalization. Permanent neurologic deficits have been reported and morbidity may be high, especially in the elderly, patients with severe underlying disease, and patients with prolonged, uncontrolled seizure activity. The onset of seizures is not always preceded by less severe symptoms of theophylline toxicity. Patients with an abnormal neurologic history, including a history of seizures, cerebral infarct, or head trauma, may be predisposed to seizure activity. If theophylline is used in these types of patients, serum concentrations should be monitored closely and maintained in the low, therapeutic range.
Cardiovascular side effects have included increases in heart rate which have progressed to supraventricular tachycardia or ventricular tachycardia. Patients with a history of arrhythmias may be predisposed to this effect. Hypotension has occurred with rapid intravenous administration.
Theophylline serum concentrations have been a significant predictor of arrhythmias. One study reported multifocal atrial tachycardia in 8% and 16% of patients with a serum concentration between 10 and 20 mcg/mL and greater than 20 mcg/mL, respectively. The onset of serious arrhythmias is not always preceded by less severe signs of theophylline toxicity.
Elevated serum CK-MB levels have been associated with theophylline toxicity in the absence of cardiac disease. CK-MB levels have returned to normal following discontinuation of theophylline therapy.
Metabolic side effects have included hypokalemia, hyperglycemia, respiratory alkalosis, hypophosphatemia, and hypomagnesemia, especially in the situation of acute overdosage. The magnitude of these abnormalities have been correlated with theophylline (the active ingredient contained in Theolair) concentrations. Hypercalcemia has been reported in a patient with hyperthyroid disease with theophylline at therapeutic concentrations.
In one group of patients with theophylline concentrations greater than 20 mcg/mL, hyperglycemia was present in approximately 50%, hypokalemia in 15%, and hypomagnesemia in 20%. Hyponatremia and hypophosphatemia were seen less frequently.
Genitourinary side effects have included urinary retention.
More Theolair resources
- Theolair tablets Prescribing Information (FDA)
- Theophylline Prescribing Information (FDA)
- Theophylline Professional Patient Advice (Wolters Kluwer)
- Elixophyllin elixir MedFacts Consumer Leaflet (Wolters Kluwer)
- Elixophyllin Prescribing Information (FDA)
- Elixophyllin Concise Consumer Information (Cerner Multum)
- Elixophyllin Advanced Consumer (Micromedex) - Includes Dosage Information
- Quibron-T MedFacts Consumer Leaflet (Wolters Kluwer)
- Quibron-T Prescribing Information (FDA)
- Theo-24 Prescribing Information (FDA)
- TheoCap Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Theochron sustained-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Theophyllines Monograph (AHFS DI)
- Uniphyl Prescribing Information (FDA)
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