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Drug ReportsSulfamethoxazole
Sulfamethoxazole
Bactrim, Gantanol, Septra, Sulfamethoxazole / Trimethoprim, Sulfatrim, Urobak (sulfamethoxazole) is a small molecule pharmaceutical. Sulfamethoxazole was first approved as Gantanol on 1982-01-01. It is used to treat bacterial infections, chlamydiaceae infections, chronic bronchitis, enterobacteriaceae infections, and mycoses amongst others in the USA.
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Drug
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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Combinations
Bactrim, Septra, Sulfamethoxazole trimethoprim, Sulfatrim (discontinued: Azo gantanol, Bactrim, Cotrim, Cotrim d.s, Septra, Septra grape, Sulfamethoxazole trimethoprim, Sulfamethoxazole trimethoprim phenazopyridine, Sulfatrim, Sulfatrim-ss, Trimeth/sulfa, Uroplus, Uroplus ss)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sulfamethoxazole
+
Trimethoprim
Tradename
Company
Number
Date
Products
SEPTRAMonarch PharmaceuticalsN-017376 RX1982-01-01
1 products
SEPTRA DSMonarch PharmaceuticalsN-017376 RX1982-01-01
1 products
SULFATRIM PEDIATRICPAI PharmaN-018615 RX1983-01-07
1 products
BACTRIMSun Pharmaceutical IndustriesN-017377 RX1982-01-01
1 products, RLD
BACTRIM DSSun Pharmaceutical IndustriesN-017377 RX1982-01-01
1 products, RLD, RS
Show 14 discontinued
Phenazopyridine hydrochloride
+
Sulfamethoxazole
Tradename
Company
Number
Date
Products
AZO GANTANOLRocheN-013294 DISCN1987-09-10
1 products, RLD
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Sulfamethoxazole
Tradename
Company
Number
Date
Products
GANTANOLRocheN-012715 DISCN1982-01-01
1 products
GANTANOL-DSRocheN-012715 DISCN1982-01-01
1 products
GANTANOLRocheN-013664 DISCN1982-01-01
1 products
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Phenazopyridine hydrochloride
+
Sulfamethoxazole
+
Trimethoprim
Tradename
Company
Number
Date
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDEAble LaboratoriesN-021105 DISCN2001-06-26
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
bactrim bactrim dsNew Drug Application2024-12-30
bactrim dsNew Drug Application2024-07-25
sulfamethox-tmp dsANDA2022-10-09
sulfamethoxazole and trimethoprimANDA2025-04-03
sulfamethoxazole and trimethoprim dsANDA2010-04-28
sulfamethoxazole, and trimethoprimANDA2009-10-09
sulfatrimNew Drug Application2025-03-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
toxoplasmosisEFO_0007517D014123B58
urinary tract infectionsEFO_0003103D014552N39.0
chronic bronchitis—D029481J42
otitis mediaEFO_0004992D010033H66.9
bacterial infections—D001424A49
enterobacteriaceae infectionsEFO_1001313D004756—
escherichia coli infectionsEFO_1001318D004927B96.20
bronchitis—D001991J40
bacterial eye infections—D015818—
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01E: Sulfonamides and trimethoprim antibacterials for systemic use
— J01EC: Intermediate-acting sulfonamides
— J01EC01: Sulfamethoxazole
— J01EE: Combinations of sulfonamides and trimethoprim, incl. derivatives
— J01EE01: Sulfamethoxazole and trimethoprim
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
Code
Description
S0039
Injection, sulfamethoxazole and trimethoprim, 10 ml
Clinical
Clinical Trials
247 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N0811———1
Kidney transplantationD016030——11———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BronchitisD001991—J40————22
Acute diseaseD000208——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSulfamethoxazole
INNsulfamethoxazole
Description
Sulfamethoxazole is an isoxazole (1,2-oxazole) compound having a methyl substituent at the 5-position and a 4-aminobenzenesulfonamido group at the 3-position. It has a role as an antibacterial agent, an antiinfective agent, an epitope, an EC 2.5.1.15 (dihydropteroate synthase) inhibitor, an antimicrobial agent, a P450 inhibitor, an EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor, an environmental contaminant, a xenobiotic and a drug allergen. It is a sulfonamide, a member of isoxazoles, a substituted aniline and a sulfonamide antibiotic. It is functionally related to a sulfanilamide.
Classification
Small molecule
Drug classantimicrobials (sulfonamides derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Identifiers
PDB—
CAS-ID723-46-6
RxCUI—
ChEMBL IDCHEMBL443
ChEBI ID9332
PubChem CID5329
DrugBankDB01015
UNII IDJE42381TNV (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Sulfamethoxazole
Total medical expenditures per year (USD, in millions)
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Sulfamethoxazole
+
Trimethoprim
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 59,325 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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42,513 adverse events reported
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