Prescription medicine
Sulfamethoxazole and trimethoprim Brand names: Sulfatrim, Bactrim, Sulfamethox-Tmp, Sulfameth; first approved as Septra
Sulfamethoxazole and trimethoprim (Bactrim) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 44 generic labelers, and pharmacies paid $0.0448 per sulfamethoxazole-tmp ds tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sulfamethoxazole and trimethoprim FDA label on DailyMed (effective December 30, 2024, Sun Pharmaceutical Industries, Inc); the NDA 17376 record on Drugs@FDA; every sulfamethoxazole and trimethoprim label on DailyMed.
Highlights of the record
FDA label of December 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Forms and strengths
- 80 mg/ml / 16 mg/ml
- 160 mg / 800 mg
- 200 mg/5ml / 40 mg/5ml
- 400 mg / 80 mg
- 800 mg / 160 mg
- 800 mg/20ml / 160 mg/20ml
Tablet; suspension; injection (solution) (concentrate).
On the market
- Earliest approval on file
- July 30, 1973 Septra, Monarch Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 36 first November 7, 1984; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 47 of which 44 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0448 per tablet Sulfamethoxazole-tmp ds tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2011 1 Class I among all firms' recalls; latest September 2, 2025
- FAERS reports
- 83,873 through July 30, 2026
What is sulfamethoxazole and trimethoprim used for?
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. […]
Conditions named in the indications of sulfamethoxazole and trimethoprim's FDA labels, with every medicine labeled for each:
From other sulfamethoxazole and trimethoprim labelsBacterial infections and Urinary tract infections: Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Diarrhea: Traveler's Diarrhea in Adults For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
FDA pharmacologic class: Dihydrofolate Reductase Inhibitor Antibacterial and Sulfonamide Antimicrobial.
Source: FDA drug label (Bactrim), Sun Pharmaceutical Industries, Inc, effective December 30, 2024 (SPL set f59d0c04-9c66-4d53-a0e1-cb55570deb62), via openFDA; the full label on DailyMed
Is there a generic for sulfamethoxazole and trimethoprim (Bactrim)?
The FDA approved the first generic sulfamethoxazole and trimethoprim on November 7, 1984. 36 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sulfamethoxazole and trimethoprim from 44 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1973 earliest approval on file
- 1984 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sulfamethoxazole and trimethoprim (Bactrim)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0448 per Sulfamethoxazole-tmp ds tablet, down 23% from $0.0579 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sulfamethoxazole-tmp ds tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sulfamethoxazole-tmp ds tablet | Generic | $0.0448 per tablet | $1.34 | -23% |
| Sulfamethoxazole-tmp ss tablet | Generic | $0.0395 per tablet | $1.18 | -4% |
| Sulfamethoxazole-tmp suspension | Generic | $0.0555 per mL | n/a | -5% |
| Sulfatrim pediatric suspension | Generic | $0.0555 per mL | n/a | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sulfamethoxazole and trimethoprim been recalled?
The FDA's Enforcement Report lists 12 recalls naming sulfamethoxazole and trimethoprim since 2011: 1 Class I (the most serious), 11 Class II, 0 Class III; 5 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 2, 2025 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was … |
| August 20, 2025 | Class II | Northwind Pharmaceuticals LLC | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was … |
| August 18, 2025 | Class II | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. … |
| June 2, 2025 | Class I | Amneal Pharmaceuticals, LLC | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| July 7, 2021 | Class II | Aurobindo Pharma USA Inc. | Presence of Foreign Substance- Potential of metal contamination. |
| August 10, 2020 | Class II | Aurobindo Pharma USA Inc. | Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). |
| April 19, 2018 | Class II | Sun Pharmaceutical Industries, Inc. | Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sulfamethoxazole and trimethoprim label say about other medicines?
The sulfamethoxazole and trimethoprim label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name sulfamethoxazole and trimethoprim. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amantadine | drug interactions | Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of BACTRIM and amantadine (an OCT2 substrate). |
| Cyclosporine | drug interactions | Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of BACTRIM and cyclosporine in renal transplant recipients. |
| Digoxin | drug interactions | Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant BACTRIM therapy, especially in elderly patients. |
| Dofetilide | contraindications | … severe renal insufficiency when renal function status cannot be monitored concomitant administration with dofetilide (see PRECAUTIONS ). |
| Glipizide | drug interactions | … hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. |
| Glyburide | drug interactions | … metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. |
| Indomethacin | drug interactions | Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin. |
| Leucovorin | warnings | Risk Associated with Concurrent Use of Leucovorin for Pneumocystis jirovecii Pneumonia Treatment failure and excess mortality were observed when BACTRIM was used concomitantly with leucovorin for the treatment of HIV positive patients with P. jirovecii pneumonia in a randomized placebo-controlled trial. |
| Memantine | drug interactions | Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported. |
| Metformin | drug interactions | … repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. |
| Methotrexate | drug interactions | Drug (s): Methotrexate; Recommendation: Avoid concurrent use; Comments: Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations. |
| Phenytoin | drug interactions | Phenytoin Monitor serum phenytoin levels BACTRIM may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). |
| Pioglitazone | drug interactions | Drug (s): Oral Hypoglycemics; Recommendation: Monitor blood glucose more frequently; Comments: Like other sulfonamide-containing drugs, BACTRIM potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or … |
| Procainamide | drug interactions | Drug (s): Procainamide; Recommendation: Closely monitor for clinical and ECG signs of procainamide toxicity and/or procainamide plasma concentration if available; Comments: Trimethoprim increases the plasma concentrations of procainamide and its active N-acetyl metabolite (NAPA) when trimethoprim and procainamide are … |
Every other medicine the sulfamethoxazole and trimethoprim label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pyrimethamine | drug interactions | Drug (s): Pyrimethamine; Recommendation: Avoid concurrent use; Comments: Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may … |
| Repaglinide | drug interactions | … oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). … |
| Warfarin | drug interactions | Warfarin Monitor prothrombin time and INR It has been reported that BACTRIM may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). |
| Zidovudine | drug interactions | Zidovudine Monitor for hematologic toxicity Zidovudine and BACTRIM are known to induce hematological abnormalities. |
Other labels that name sulfamethoxazole and trimethoprim
Check sulfamethoxazole and trimethoprim against other medicines
Source: FDA drug label (Bactrim), Sun Pharmaceutical Industries, Inc, effective December 30, 2024 (SPL set f59d0c04-9c66-4d53-a0e1-cb55570deb62), via openFDA; the full label on DailyMed
What do FAERS reports show for sulfamethoxazole and trimethoprim?
The FDA Adverse Event Reporting System holds 83,873 reports that list sulfamethoxazole and trimethoprim among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,343 are coded as a death and 42,373 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sulfamethoxazole and trimethoprim?
26 other medicines are given the same way (oral) and in the same FDA class as sulfamethoxazole and trimethoprim or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Amoxicillin and clavulanate | Bacterial infections, Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections, Urinary tract infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Ciprofloxacin | Diarrhea, Bacterial infections, Urinary tract infections | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Nitrofurantoin | Bacterial infections, Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other dihydrofolate reductase inhibitor antibacterials
- the pharmacologic class, with prices and generics
- Sulfamethoxazole and trimethoprim side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other