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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
Target
Variants
Financial
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3M
6M
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2Y
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FDA approval date
EMA approval date
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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 Application2024-07-02
bactrim dsNew Drug Application2024-07-25
sulfamethox-tmp dsANDA2022-10-09
sulfamethoxazole and trimethoprimANDA2024-10-30
sulfamethoxazole and trimethoprim dsANDA2010-04-28
sulfamethoxazole, and trimethoprimANDA2009-10-09
sulfatrimNew Drug Application2024-09-12
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
279 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—31818202074
Hiv infectionsD015658EFO_0000764B20482061752
Communicable diseasesD003141——2913141551
PneumoniaD011014EFO_0003106—271971244
Urinary tract infectionsD014552EFO_0003103N39.0196101135
Pneumocystis pneumoniaD011020EFO_0007448B5937145733
MalariaD008288EFO_0001068B54—2102519
Acquired immunodeficiency syndromeD000163EFO_0000765B20—144615
HivD006678———133714
AbscessD000038EFO_0003030———22610
Show 71 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Staphylococcal infectionsD013203—A49.01—55—615
Bacterial infectionsD001424—A49511—29
Multiple myelomaD009101—C90.0251——7
Plasma cell neoplasmsD054219——251——7
SepsisD018805HP_0100806A41.9—13—37
SyndromeD013577——221—15
NeoplasmsD009369—C80321——4
FibrosisD005355———22——4
MalnutritionD044342EFO_0008572E40-E46——1—23
Covid-19D000086382———21—13
Show 43 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Staphylococcus aureusD013211NCBITaxon_1280——2——46
LymphomaD008223—C85.914——15
LeukemiaD007938—C9533———4
Infectious arthritisD001170EFO_1001351M00—1——23
Precursor cell lymphoblastic leukemia-lymphomaD054198——22———3
Lymphoid leukemiaD007945—C9122———3
CellulitisD002481EFO_0003035L03.90—1——23
Cystic fibrosisD003550EFO_0000390E84—3———3
Disease progressionD018450——11——23
SinusitisD012852EFO_0007486J32—1——12
Show 26 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prosthesis-related infectionsD016459EFO_1001406—1———23
Healthy volunteers/patients———2————2
Congenital microtiaD065817—Q16.01————1
Brain neoplasmsD001932EFO_0003833C711————1
GlioblastomaD005909EFO_0000515—1————1
AstrocytomaD001254EFO_0000271—1————1
Macular degenerationD008268EFO_0001365H35.301————1
Geographic atrophyD057092——1————1
AtrophyD001284——1————1
Small cell carcinomaD018288——1————1
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BronchitisD001991—J40————33
HypospadiasD007021EFO_0004209Q54————33
UlcerD014456MPATH_579—————22
Surgical wound infectionD013530——————22
Retinal detachmentD012163EFO_0005773H33.2————11
Aortic dissectionD000784—I71.0————11
DeathD003643PATO_0001422—————11
Long qt syndromeD008133HP_0001657I45.81————11
DeliriumD003693—R41.0————11
Torsades de pointesD016171EFO_0005307I47.21————11
Show 37 more
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
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Trimethoprim
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 56,384 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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43,889 adverse events reported
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