Theophylline
Elixophyllin, Theo, Theochron, Theophylline (theophylline) is a small molecule pharmaceutical. Theophylline was first approved as Mersalyl-theophylline on 1982-01-01. It is used to treat apnea, asthma, bradycardia, bronchial spasm, and bronchitis amongst others in the USA. The pharmaceutical is active against adenosine receptor A2b and adenosine receptor A2a. In addition, it is known to target adenosine receptor A1 and adenosine receptor A3.
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Commercial
Trade Name
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Elixophyllin, Theo, Theochron, Theophylline (discontinued: Accurbron, Aquaphyllin, Asbron, Bronkodyl, Duraphyl, Elixicon, Elixophyllin, Labid, Lanophyllin, Quibron-t, Quibron-t/sr, Slo-bid, Slo-phyllin, Somophyllin-t, Sustaire, Synophylate, T-phyl, Theo-dur, Theoclear, Theolair, Theolair-sr, Theolixir, Theophyl, Theophyl-sr, Theophylline, Theophylline-sr, Theovent, Uni-dur)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Procaine merethoxylline
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Theophylline
Theophylline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019083 DISCN | 1984-11-07 | 1 products |
| THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019083 DISCN | 1984-11-07 | 1 products |
| THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019083 DISCN | 1984-11-07 | 1 products |
| THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019212 DISCN | 1984-11-07 | 1 products |
| THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019212 DISCN | 1984-11-07 | 2 products |
| THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products, RLD |
| THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products, RLD |
| THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products, RLD |
| THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products |
| THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products |
| THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019826 DISCN | 1992-08-14 | 1 products, RLD |
| THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER | Baxter | N-018649 DISCN | 1982-07-26 | 7 products |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | Hospira | N-019211 DISCN | 1984-12-14 | 7 products, RLD |
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Theophylline sodium glycinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYNOPHYLATE | Central Pharmaceuticals | N-006333 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elixophyllin | ANDA | 2018-12-13 |
| quibron-t | 2006-11-09 | |
| senophylline | unapproved drug other | 2011-08-01 |
| theo-24 | ANDA | 2024-07-08 |
| theophylline | ANDA | 2024-11-20 |
| theophylline in dextrose | New Drug Application | 2017-08-11 |
| uniphyl | ANDA | 2011-10-24 |
Indications
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Agency Specific
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ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03D: Other systemic drugs for obstructive airway diseases in atc
— R03DA: Xanthines, systemic for obstructive airway disease
— R03DA04: Theophylline
— R03DA54: Theophylline, combinations excl. psycholeptics
— R03DA74: Theophylline, combinations with psycholeptics
— R03DB: Xanthines and adrenergics
— R03DB04: Theophylline and adrenergics
HCPCS
Code | Description |
|---|---|
| J2810 | Injection, theophylline, per 40 mg |
Clinical
Clinical Trials
89 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 3 | 4 | 4 | 8 | 18 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 3 | 6 | 6 | 1 | 15 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | 1 | 1 | 4 | 6 | 12 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 2 | 4 | 3 | 9 |
| Pseudopseudohypoparathyroidism | D011556 | — | — | — | 4 | — | 1 | — | 5 |
| Pseudohypoparathyroidism | D011547 | — | E20.1 | — | 4 | — | 1 | — | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | 1 | 1 | 1 | 4 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | 1 | — | 3 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | 1 | 2 | 3 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Altitude sickness | D000532 | EFO_1000782 | T70.29 | 3 | 1 | 1 | — | — | 4 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | 1 | — | 1 | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | 2 | 1 | — | — | 2 |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | 1 | 1 | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | 1 | — | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | 1 | — | — | 1 |
| Disease progression | D018450 | — | — | — | — | 1 | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | 1 | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 3 |
| Olfaction disorders | D000857 | HP_0000458 | R43.0 | — | 3 | — | — | — | 3 |
| Anosmia | D000086582 | — | — | 1 | 2 | — | — | — | 3 |
| Covid-19 | D000086382 | — | — | — | 2 | — | — | — | 2 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 1 | — | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 1 | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | 1 | — | — | — | 1 |
| Ageusia | D000370 | EFO_1001758 | — | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | — | — | — | — | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 2 | — | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Blood flow velocity | D001783 | — | — | 1 | — | — | — | — | 1 |
| Coronary circulation | D003326 | — | — | 1 | — | — | — | — | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | 1 | — | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache disorders | D020773 | EFO_0009550 | G44 | — | — | — | — | 1 | 1 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | — | — | 1 | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | — | — | 1 | 1 |
| Ganglion cysts | D045888 | — | M67.4 | — | — | — | — | 1 | 1 |
| Affect | D000339 | — | — | — | — | — | — | 1 | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 1 | 1 |
| Skin care | D017592 | — | — | — | — | — | — | 1 | 1 |
| Syncope | D013575 | HP_0012668 | G90.01 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
| Angle-closure glaucoma | D015812 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Theophylline |
| INN | — |
| Description | Theophylline is a dimethylxanthine having the two methyl groups located at positions 1 and 3. It is structurally similar to caffeine and is found in green and black tea. It has a role as a vasodilator agent, a bronchodilator agent, a muscle relaxant, an EC 3.1.4.* (phosphoric diester hydrolase) inhibitor, an anti-asthmatic drug, an anti-inflammatory agent, an immunomodulator, an adenosine receptor antagonist, a drug metabolite, a fungal metabolite and a human blood serum metabolite. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1c(=O)c2[nH]cnc2n(C)c1=O |
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Estimated US medical usage
Theophylline
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Hydroxyzine
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Ephedrine
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Theophylline
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Guaifenesin
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Theophylline
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Safety
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5,780 adverse events reported
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