Prescription medication · Sulfonamide Antibiotic Combination
sulfamethoxazole/trimethoprim
Also sold as Bactrim, Septra. This medicine can treat urinary tract infections, ear infections, bronchitis, and traveler's diarrhea.
Data updated 2026-05-15
- 43,818
- FDA reports
- Rx
- Availability
sulfamethoxazole/trimethoprim (Bactrim) is a prescription Sulfonamide Antibiotic Combination. This medicine can treat urinary tract infections, ear infections, bronchitis, and traveler's diarrhea.
Sulfamethoxazole and trimethoprim is a combination antibiotic. It is used to treat bacterial infections.
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What it does
This medicine can treat urinary tract infections, ear infections, bronchitis, and traveler's diarrhea.
Common side effects
Nausea, Vomiting, Loss of appetite
Key warnings
Rarely, this medicine has caused severe reactions, including Stevens-Johnson syndrome and liver damage, which can be deadly.
The sections below are summarized in plain English from sulfamethoxazole/trimethoprim's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
This medicine contains two drugs that work together to kill bacteria. Sulfamethoxazole and trimethoprim both stop bacteria from making folic acid. Bacteria need folic acid to grow and multiply.
Side Effects (from patient reports)
Based on 43,818 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sulfamethoxazole/trimethoprim, by number of reports
- Fever
Fever
6,174 reports
- Tiredness
Tiredness
5,208 reports
- Diarrhea
Diarrhea
4,754 reports
- Feeling sick to your stomach
Feeling sick to your stomach
4,728 reports
- Skin rash
Skin rash
4,365 reports
- Difficulty breathing
Difficulty breathing
4,280 reports
- Pain
Pain
4,012 reports
- Throwing up
Throwing up
3,675 reports
- Pneumonia
Pneumonia
3,350 reports
- Allergic reaction to the medicine
Allergic reaction to the medicine
3,272 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
Rarely, this medicine has caused severe reactions, including Stevens-Johnson syndrome and liver damage, which can be deadly. Tell your doctor right away if you have a fever, rash, blisters, mouth sores, or yellowing of your skin or eyes.
Common Questions
Can I drink alcohol while taking this medicine?
How long should I take this medicine?
What should I do if I have diarrhea?
Can this medicine interact with other medicines I am taking?
What if I am allergic to sulfa drugs?
Can this medicine cause sun sensitivity?
Is it okay to drive while taking this medication?
What if I feel worse after starting this medicine?
Can I take this medication if I have kidney problems?
Can this medication be used for a viral infection?
What are the common side effects of sulfamethoxazole/trimethoprim?
What drug class is sulfamethoxazole/trimethoprim?
What pregnancy or breastfeeding source fields are listed for sulfamethoxazole/trimethoprim?
Related Medications in Sulfonamide Antibiotic Combination
Other drugs grouped near sulfamethoxazole/trimethoprim - same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
Compare with sulfamethoxazole/trimethoprim →
amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
Compare with sulfamethoxazole/trimethoprim →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with sulfamethoxazole/trimethoprim →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with sulfamethoxazole/trimethoprim →
azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
Compare with sulfamethoxazole/trimethoprim →
Compare sulfamethoxazole/trimethoprim vs amikacin side-by-side →
Medication Guides
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FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sulfamethoxazole/trimethoprim
The FDA label for sulfamethoxazole/trimethoprim (sold under brand names such as Bactrim, Septra) classifies it as a prescription-only medication in the Sulfonamide Antibiotic Combination class. This medicine can treat urinary tract infections, ear infections, bronchitis, and traveler's diarrhea. Official labeling lists 4 commonly reported side effects, including Nausea, Vomiting, Loss of appetite.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 43,818 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 9, 2022
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages