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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Commercial
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
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Trimethoprim
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SEPTRA | Monarch Pharmaceuticals | N-017376 RX | 1982-01-01 | 1 products |
| SEPTRA DS | Monarch Pharmaceuticals | N-017376 RX | 1982-01-01 | 1 products |
| SULFATRIM PEDIATRIC | PAI Pharma | N-018615 RX | 1983-01-07 | 1 products |
| BACTRIM | Sun Pharmaceutical Industries | N-017377 RX | 1982-01-01 | 1 products, RLD |
| BACTRIM DS | Sun Pharmaceutical Industries | N-017377 RX | 1982-01-01 | 1 products, RLD, RS |
Show 14 discontinued
Phenazopyridine hydrochloride
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Sulfamethoxazole
Sulfamethoxazole
Phenazopyridine hydrochloride
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Sulfamethoxazole
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Trimethoprim
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE | Able Laboratories | N-021105 DISCN | 2001-06-26 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bactrim bactrim ds | New Drug Application | 2024-12-30 |
| bactrim ds | ANDA | 2020-11-25 |
| sulfamethox-tmp ds | ANDA | 2022-10-09 |
| sulfamethoxazole and trimethoprim | ANDA | 2025-11-21 |
| sulfamethoxazole and trimethoprim ds | ANDA | 2010-04-28 |
| sulfamethoxazole, and trimethoprim | ANDA | 2009-10-09 |
| sulfatrim | New Drug Application | 2025-03-06 |
Indications
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Agency Specific
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Patent Expiration
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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
260 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | 13 | 13 | 15 | 13 | 51 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 8 | 16 | 4 | 10 | 39 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | 7 | 5 | 13 | 11 | 36 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | 2 | 6 | 14 | 5 | 10 | 35 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 3 | 12 | 5 | 6 | 26 |
| Communicable diseases | D003141 | — | — | 1 | 4 | 4 | 6 | 9 | 24 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 2 | 4 | 8 | 3 | 7 | 22 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | 8 | 1 | 4 | 14 |
| Staphylococcal infections | D013203 | — | A49.01 | — | 4 | 4 | 1 | 5 | 13 |
| Abscess | D000038 | EFO_0003030 | — | — | 1 | 2 | 2 | 6 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aids-related opportunistic infections | D017088 | — | — | — | 1 | 6 | — | 3 | 10 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | 5 | — | 3 | 9 |
| Lymphoma | D008223 | — | C85.9 | 1 | 7 | 3 | — | 1 | 8 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 7 | 4 | — | — | 8 |
| Bacterial infections | D001424 | — | A49 | 3 | 1 | 1 | — | 2 | 7 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | 2 | 1 | — | 4 | 7 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 7 | 3 | — | — | 7 |
| Leukemia | D007938 | — | C95 | 2 | 5 | 3 | — | — | 6 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 2 | 3 | 1 | — | 1 | 5 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | 2 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | 2 | — | — | 4 | 6 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 3 | 3 | — | — | — | 4 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 3 | — | — | — | 3 |
| Disease progression | D018450 | — | — | 1 | 1 | — | — | 2 | 3 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | — | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | 1 | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | 1 | 2 |
| Philadelphia chromosome | D010677 | — | — | 2 | 1 | — | — | — | 2 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | 1 | 2 |
Show 51 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prosthesis-related infections | D016459 | EFO_1001406 | — | 1 | — | — | — | 2 | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Congenital microtia | D065817 | — | Q16.0 | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
| Geographic atrophy | D057092 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Small cell carcinoma | D018288 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchitis | D001991 | — | J40 | — | — | — | — | 3 | 3 |
| Surgical wound | D000072836 | — | — | — | — | — | — | 3 | 3 |
| Hypospadias | D007021 | EFO_0004209 | Q54 | — | — | — | — | 3 | 3 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | — | 2 | 2 |
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 1 | 1 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sulfamethoxazole |
| INN | sulfamethoxazole |
| 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 class | antimicrobials (sulfonamides derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1 |
Identifiers
| PDB | — |
| CAS-ID | 723-46-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL443 |
| ChEBI ID | 9332 |
| PubChem CID | 5329 |
| DrugBank | DB01015 |
| UNII ID | JE42381TNV (ChemIDplus, GSRS) |
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Estimated US medical usage
Sulfamethoxazole
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Sulfamethoxazole
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Trimethoprim
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Safety
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Adverse Events
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45,753 adverse events reported
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