Medical Editor: John P. Cunha, DO, FACOEP
What Is Uniphyl?
What Are Side Effects of Uniphyl?
Common side effects of Uniphyl (theophylline, anhydrous) include stomach pain/cramping, upset stomach, nausea, vomiting, diarrhea, loss of appetite, headache, trouble sleeping (insomnia), irritability, restlessness, nervousness, shaking, sweating, flushing, and increased urination.
Dosage for Uniphyl
Uniphyl 400 or 600 mg tablets can be taken once a day in the morning or evening.
What Drugs, Substances, or Supplements Interact with Uniphyl?
Uniphyl may interact with carbamazepine, cimetidine, enoxacin, ephedrine or similar medications found in cold medicine or diet pills, erythromycin, fluvoxamine, propranolol, rifampin, St. John's wort, thiabendazole, or other drugs. Tell your doctor all medications and supplements you use.
Uniphyl During Pregnancy or Breastfeeding
During pregnancy, Uniphyl should be used only when prescribed. Changes in your body during the last 3 months of pregnancy may affect the amount of this drug in your blood. Your doctor should monitor the amount of drug in your blood, as well as any side effects, so your dose may be changed if needed. This drug passes into breast milk and may have undesirable effects on a nursing infant (e.g., irritability). Consult your doctor before breastfeeding.
Our Uniphyl (theophylline, anhydrous) 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.
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:
- severe or continued vomiting;
- ongoing headache, trouble sleeping;
- rapid heartbeats;
- a seizure;
- new signs of illness (especially fever);
- low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.
Serious side effects may be more likely in older adults.
Common side effects may include:
- nausea, vomiting, diarrhea;
- sleep problems (insomnia);
- sweating; or
- feeling restless or irritable.
Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see OVERDOSAGE). The transient caffeinelike adverse reactions occur in about 50% of patients when theophylline therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond > 1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects (see DOSAGE AND ADMINISTRATION, Table V). In a small percentage of patients ( < 3% of children and < 10% of adults) the caffeine-like adverse effects persist during maintenance therapy, even at peak serum theophylline concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued theophylline therapy and the potential therapeutic benefit of alternative treatment.
Other adverse reactions that have been reported at serum theophylline concentrations < 20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum theophylline concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).
TABLE IV. Manifestations of
theophylline toxicity. *
|Percentage of patients reported with sign or symptom|
(Large Single Ingestion)
(Multiple Excessive Doses)
(n = 157)
(n = 14)
(n = 92)
(n = 102)
|Other supraventricular tachycardias||2||21||12||14|
|Ventricular premature beats||3||21||10||19|
|Atrial fibrillation or flutter||1||NR**||12||NR**|
|Multifocal atrial tachycardia||0||NR**||2||NR**|
|Ventricular arrhythmias with hemodynamic instability||7||14||40||0|
|*These data are derived from two studies in patients with serum theophylline concentrations > 30 mcg/mL. In the first study (Study #1—Shanon, Ann Intern Med 1993;119:1161-67), data were prospectively collected from 249 consecutive cases of theophylline toxicity referred to a regional poison center for consultation. In the second study (Study #2—Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum theophylline concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum theophylline concentrations in three emergency departments. Differences in the incidence of manifestations of theophylline toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48% of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results.
**NR = Not reported in a comparable manner.
Read the entire FDA prescribing information for Uniphyl (Theophylline Anhydrous Tablet)
© Uniphyl Patient Information is supplied by Cerner Multum, Inc. and Uniphyl Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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