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Drug ReportsTheophylline
Theophylline
Elixophyllin, Theo, 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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5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
cardiovascular diseasesD002318
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Elixophyllin, Theo, 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
Tradename
Company
Number
Date
Products
DICURIN PROCAINEEli LillyN-008869 DISCN1982-01-01
1 products
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Theophylline
Tradename
Company
Number
Date
Products
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019083 DISCN1984-11-07
1 products
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019083 DISCN1984-11-07
1 products
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019083 DISCN1984-11-07
1 products
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019212 DISCN1984-11-07
1 products
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019212 DISCN1984-11-07
2 products
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products, RLD
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products, RLD
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products, RLD
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINERB. Braun MedicalN-019826 DISCN1992-08-14
1 products, RLD
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERBaxterN-018649 DISCN1982-07-26
7 products
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINERHospiraN-019211 DISCN1984-12-14
7 products, RLD
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Theophylline sodium glycinate
Tradename
Company
Number
Date
Products
SYNOPHYLATECentral PharmaceuticalsN-006333 DISCN1982-01-01
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
elixophyllinANDA2018-12-13
quibron-t2006-11-09
senophyllineunapproved drug other2011-08-01
theo-24ANDA2024-07-08
theophyllineANDA2025-07-10
theophylline in dextroseNew Drug Application2017-08-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
bronchitis—D001991J40
bradycardia—D001919R00.1
apnea—D001049R06.81
pulmonary emphysema—D011656J43
bronchial spasm—D001986—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
129 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Major depressive disorderD003865EFO_0003761F221————1
Depressive disorderD003866EFO_1002014F32.A1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTheophylline
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cn1c(=O)c2[nH]cnc2n(C)c1=O
Identifiers
PDB—
CAS-ID58-55-9
RxCUI91178
ChEMBL IDCHEMBL190
ChEBI ID28177
PubChem CID2153
DrugBankDB00277
UNII ID—
Target
Agency Approved
No data
Alternate
ADORA1
ADORA1
Organism
Homo sapiens
Gene name
ADORA1
Gene synonyms
NCBI Gene ID
134
Protein name
adenosine receptor A1
Protein synonyms
Uniprot ID
Q8TAM8
Mouse ortholog
Adora1 (11539)
adenosine receptor A1 (Q9WUF9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Theophylline
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Hydroxyzine
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Ephedrine
Total medical expenditures per year (USD, in millions)
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Theophylline
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Guaifenesin
Total medical expenditures per year (USD, in millions)
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Theophylline
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,020 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,587 adverse events reported
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