Elixophyllin Side Effects

Generic Name: theophylline

Note: This page contains information about the side effects of theophylline. Some of the dosage forms included on this document may not apply to the brand name Elixophyllin.

Not all side effects for Elixophyllin 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 theophylline: oral capsule, oral capsule extended release, oral capsule extended release 12 hr, oral capsule extended release 24 hr, oral elixir, oral solution, oral syrup, oral tablet, oral tablet enteric coated, oral tablet extended release, oral tablet extended release 12 hr, oral tablet extended release 24 hr

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by theophylline (the active ingredient contained in Elixophyllin). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking theophylline:

Incidence not known
  • Chest pain or discomfort
  • dizziness
  • fainting
  • fast, slow, or irregular heartbeat
  • increase in urine volume
  • lightheadedness
  • persistent vomiting
  • pounding or rapid pulse
  • seizures
  • shakiness

If any of the following symptoms of overdose occur while taking theophylline, get emergency help immediately:

Symptoms of overdose
  • Abdominal or stomach pain
  • blurred vision
  • confusion
  • confusion about identity, place, and time
  • dark-colored urine
  • decrease in frequency of urination
  • decreased urine
  • diarrhea
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • painful urination
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

Some of the side effects that can occur with theophylline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known
  • Headache
  • irritability
  • restlessness
  • sleeplessness
  • trouble sleeping
  • unable to sleep

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

General

The majority of side effects have been dependent on the serum concentration. Generally, serum concentrations of theophylline (the active ingredient contained in Elixophyllin) 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

Gastrointestinal side effects have included anorexia, nausea, vomiting, and abdominal pain. Theophylline (the active ingredient contained in Elixophyllin) may also cause locally-mediated gastrointestinal upset.

Nervous system

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 Elixophyllin) 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

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

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 Elixophyllin) 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

Genitourinary side effects have included urinary retention.

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