Theophylline
Theospirex · ATC code R03DA04
Also known as: Theophyllin, Teofilin, Teofillina, Théophylline, Teofilina · Brand names: Theo-24, Afpred Forte-Theo, Bronchoretard, Theophyllin Aristo, Theophyllin Retard Ratiopharm, Theophyllin Stada, Theospirex, Bronkolin, Polteofilin, Teobag, Teofil SR, Teokap SR, Teosel, Xanthium
- Key facts
- Active substance
- Theophylline
- Drug class
- Xanthines
- ATC code
- R03DA04
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Theophylline is a methylxanthine bronchodilator. Per the US label it is used for chronic asthma and other chronic lung diseases with reversible airflow obstruction.
What it is used for
- Symptoms and reversible airflow obstruction of chronic asthma
- Other chronic lung diseases, e.g. emphysema and chronic bronchitis
Dosing
- Individualise; target peak serum concentration in the 10-20 mcg/mL range
- Start low and increase slowly, at intervals of no less than 3 days, guided by serum levels
- Calculate mg/kg doses on ideal body weight
- Measure serum levels at initiation, before dose increases, with signs of toxicity, and with new illness or changes in co-medication
- Reduced clearance (e.g. neonates, elderly, heart failure, liver disease, fever) requires dose reduction; schemes in the full text
Contraindications
- Hypersensitivity to theophylline or other components
Important warnings
- Extreme caution in active peptic ulcer disease, seizure disorders and cardiac arrhythmias
- Without dose reduction when clearance is reduced, severe and potentially fatal toxicity can occur
- Smoking cessation can alter clearance
- Above 20 mcg/mL: persistent vomiting, cardiac arrhythmias and intractable seizures may occur
Side effects
- Transient caffeine-like effects: nausea, vomiting, headache, insomnia
- At high levels: cardiac arrhythmias and seizures, which can be lethal
Interactions
- Inhibitors of theophylline metabolism (e.g. cimetidine, erythromycin, tacrine) raise levels
- Stopping inducers (e.g. carbamazepine, rifampin) can raise levels
Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
USA
- Theo-24ENDO USA, Inc. · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Germany
- Afpred Forte-TheoGlenwood Gmbh · 1 register entry
- BronchoretardGlenwood Gmbh · 5 register entries
- Theophyllin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Theophyllin Retard RatiopharmRatiopharm Gmbh · 1 register entry
- Theophyllin StadaStadapharm Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Austria
- TheospirexGebro Pharma Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- BronkolinADEKA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- PolteofilinPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- TeobagKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
- Teofil SRULKAR KİMYA SAN. VE TİC. A.Ş. · 3 register entries
- Teokap SRNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- TeoselOSEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- XanthiumGALEPHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 23 more European countries
- Belgium
- Xanthium
- Bulgaria
- Теотард
- Croatia
- Teotard
- Cyprus
- Theo-Dur
- Czechia
- Euphyllin Cr N
- Denmark
- Theo-Dur, Unixan
- Estonia
- Teotard
- Finland
- Retafyllin
- France
- Dilatrane, Tedralan, Théostat
- Greece
- Theo-Bros, Theo-Dur, Uniphyllin
- Hungary
- Theophyllini Fono Vii. Naturland, Theophyllini Fono Viii. Parma, Theospirex
- Ireland
- Uniphyllin
- Latvia
- Teotard
- Lithuania
- Teotard
- Luxembourg
- Xanthium
- Norway
- Theo-Dur
- Poland
- Euphyllin Long, Theophyllinum Tramco, Theospirex
- Portugal
- Unicontin
- Romania
- Teotard
- Slovakia
- Euphyllin Cr N
- Slovenia
- Teotard
- Spain
- Elixifilin, Teromol Retard, Theo-Dur
- Sweden
- Theo-Dur
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Theophylline (Chartwell RX, LLC) – Prescribing Information, 2026-02-06. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1b685384-5d96-46fa-b93b-e96538a2cfe7
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC R03DA.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.