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Theophylline Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 15, 2023.

Applies to theophylline: oral capsule extended release 24 hr, oral elixir, oral solution, oral tablet extended release, oral tablet extended release 12 hr, oral tablet extended release 24 hr. Other dosage forms:

Serious side effects of Theophylline

Along with its needed effects, theophylline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking theophylline:

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking theophylline:

Symptoms of overdose

Other side effects of Theophylline

Some side effects of theophylline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

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

Adverse events are generally mild when theophylline levels are under 20 mcg/mL; the most common adverse events were caffeine-like adverse effects like nausea, vomiting, headache, and insomnia.

When theophylline concentrations exceed 20 mcg/mL, many adverse effects may occur, including persistent vomiting, cardiac arrhythmias, and intractable seizures, which may be fatal.[Ref]

Cardiovascular

Very common (10% or more): Sinus tachycardia (up to 100% in acute overdose, up to 100% with chronic overdose), ventricular arrhythmias with hemodynamic instability (14% in acute overdose, 40% with chronic overdose), other supraventricular tachycardias (21% in acute overdose, 14% with chronic overdose), ventricular premature beats (21% in acute overdose, 19% with chronic overdose), hypotension/shock (21% in acute overdose, 8% with chronic overdose), atrial fibrillation or flutter (1% in acute overdose, 12% with chronic overdose)

Common (1% to 10%): Multifocal atrial tachycardia (2% with chronic overdose)

Frequency not reported: Cardiac arrhythmias (at serum concentrations over 20 mcg/mL), multifocal atrial tachycardia and flutter (at serum concentrations 15 mcg/mL and over in hypoxia secondary to COPD patients)[Ref]

Nervous system

-A few seizures have been reported in patients with underlying neurological disease or in elderly patients with serum theophylline under 20 mcg/mL.

-Seizures in elderly patients with serum theophylline under 20 mcg/mL may be due to decreased protein binding causing higher unbound (pharmacologically active) theophylline levels.

-Seizures in patients with serum theophylline under 20 mcg/mL were generally milder (than those from overdose) such as being transient, not requiring anticonvulsants, and no neurological residuals.

-Consider the possibility of non-convulsive status epilepticus in patients with abnormal central nervous system function and theophylline use.[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (93% in acute overdose, 61% with chronic overdose), abdominal pain (21% in acute overdose, 12% with chronic overdose), diarrhea (14% with chronic overdose)

Common (1% to 10%): Hematemesis (2% with chronic overdose)

Frequency not reported: Nausea, vomiting, persistent vomiting (at serum concentrations over 20 mcg/mL), diarrhea[Ref]

Nervous system

Very common (10% or more): Tremors (38% in acute overdose, 16% with chronic overdose), seizures (14% in acute overdose, 14% with chronic overdose)

Frequency not reported: Headache, intractable seizures (at serum concentrations over 20 mcg/mL), seizures[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (98% in acute overdose, 18% with chronic overdose), hypokalemia (85% in acute overdose, 44% with chronic overdose), acid/base disturbance (34% in acute overdose, 9% with chronic overdose)

Frequency not reported: Hypercalcemia (in a hyperthyroid patient), hypervolemia[Ref]

Psychiatric

Very common (10% or more): Nervousness (64% in acute overdose, 21% with chronic overdose), disorientation (7% in acute overdose, 12% with chronic overdose)

Frequency not reported: Insomnia, irritability, restlessness[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Rhabdomyolysis (7% in acute overdose)

Frequency not reported: Fine skeletal muscle tremors[Ref]

Other

Very common (10% or more): Death (21% in acute overdose, 10% with chronic overdose)

Frequency not reported: Febrile response[Ref]

Genitourinary

Frequency not reported: Transient diuresis[Ref]

Local

Frequency not reported: Infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation[Ref]

References

1. Product Information. Theophylline (theophylline). B. Braun Medical. 2018.

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.