Theophylline: uses, dosing, side effects & brands
Theophylline is a medicine sold in the U.S. under 5 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Tablet, extended release · Injectable · Capsule · Capsule, extended release · Solution
- Sold as
- 5 products — Labid, Theophylline in Dextrose 5% in Plastic Container and Somophyllin-T, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 8.7 hours on average (range roughly 6 to 13 hours) in otherwise healthy non-smoking adults 16-60 years
- What the pharmacy pays
- about $0.86 per ml — not your price
Every theophylline product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | 58/100 | Prescription | Injectable | Generic | $1 | View → | |
| 3 | Not yet rated | Prescription | Capsule | Generic | $1 | View → | |
| 4 | Not yet rated | Prescription | Capsule | Generic | $1 | View → | |
| 5 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
What theophylline pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Theophylline recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Theophylline extended-release tablets 400mg
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Glenmark Pharmaceuticals Inc., USA · Aug 8, 2025
Theophylline (Anhydrous) Extended-Release Tablets
OOS results reported for the Dissolution (by UV) test.
Glenmark Pharmaceuticals Inc., USA · May 15, 2025
How long theophylline keeps
No theophylline label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Theophylline and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for theophylline: levels in milk, effects in breastfed infants, and the drugs it would consider insteadExpert opinion considers use of theophylline to be acceptable during breastfeeding. Maternal theophylline use may occasionally cause stimulation and irritability and fretful sleep in infants. Newborn and especially preterm infants are most likely to be affected because of their slow elimination and low serum protein binding of theophylline. There is no need to avoid theophylline products; however, keep maternal serum concentrations in the lower part of the therapeutic range and monitor the infant for signs of theophylline side effects. Infant serum theophylline concentrations can help to determine if signs of agitation are due to theophylline. Avoiding breastfeeding for 2 hours after intravenous or 4 hours after an immediate-release oral theophylline product can decrease the dose received by the breastfed infant. When theophylline is given as an oral sustained-release product, timing of nursing with respect to the dose is of little or no benefit.
National Institute of Child Health and Human Development, record revised May 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about theophylline
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 13,211 reports naming theophylline, and the FDA flagged 82% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea2,560 reports
- asthma2,201 reports
- pneumonia1,528 reports
- wheezing1,482 reports
- vomiting1,297 reports
- cough1,172 reports
- drug hypersensitivity987 reports
- malaise843 reports
Read these as a signal, not a rate. A report does not mean theophylline caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
How long theophylline stays in your system
The elimination half-life of theophylline is about 8.7 hours on average (range roughly 6 to 13 hours) in otherwise healthy non-smoking adults 16-60 years. This is the elimination half-life; the label's Table I reports it directly and theophylline follows one-compartment-like kinetics with no clinically relevant longer-lasting active metabolite in adults and it is not a prodrug. The half-life is highly variable and rises markedly in several named populations: elderly (>60 years, normal cardiac/liver/renal function) about 9.8 h (range 1.6-18); liver disease prolongs it substantially - cirrhosis about 32 h (10-56), acute hepatitis about 19 h, cholestasis about 14 h; also longer in acute pulmonary edema (~19 h), sepsis with multi-organ failure (~19 h), and 3rd-trimester pregnancy (~13 h). Because theophylline is cleared by hepatic metabolism, the label ties prolongation to liver dysfunction and age rather than to kidney impairment (renal impairment is not listed as prolonging half-life in adults). The kinetics are non-linear, so half-life increases further at serum concentrations above ~20 mcg/mL. Half-life is shorter in smokers, children, and hyperthyroidism.
Theophylline (Anhydrous) Extended-Release Tablets - DailyMed label, Clinical Pharmacology (Table I) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
How long does theophylline stay in your system?
The elimination half-life of theophylline is about 8.7 hours on average (range roughly 6 to 13 hours) in otherwise healthy non-smoking adults 16-60 years — that is how long the body takes to clear half of a dose. This is the elimination half-life; the label's Table I reports it directly and theophylline follows one-compartment-like kinetics with no clinically relevant longer-lasting active metabolite in adults and it is not a prodrug. The half-life is highly variable and rises markedly in several named populations: elderly (>60 years, normal cardiac/liver/renal function) about 9.8 h (range 1.6-18); liver disease prolongs it substantially - cirrhosis about 32 h (10-56), acute hepatitis about 19 h, cholestasis about 14 h; also longer in acute pulmonary edema (~19 h), sepsis with multi-organ failure (~19 h), and 3rd-trimester pregnancy (~13 h). Because theophylline is cleared by hepatic metabolism, the label ties prolongation to liver dysfunction and age rather than to kidney impairment (renal impairment is not listed as prolonging half-life in adults). The kinetics are non-linear, so half-life increases further at serum concentrations above ~20 mcg/mL. Half-life is shorter in smokers, children, and hyperthyroidism. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take theophylline with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run theophylline against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is theophylline sold under?
We track 5 theophylline-containing products in the U.S.: Labid, Theophylline in Dextrose 5% in Plastic Container, Somophyllin-T, Theobid and Theophylline. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does theophylline come in?
Across the brands we track, theophylline is currently marketed as tablet, extended release, injectable, capsule, capsule, extended release and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic theophylline?
Yes. Our catalog lists 4 generic theophylline products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has theophylline been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions theophylline. The most recent: Theophylline extended-release tablets 400mg (Aug 8, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Theophylline: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/theophylline
- MLA
- “Theophylline: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/theophylline.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for theophylline on DailyMed (NIH) ↗.