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trimethoprim

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Brand names: Primsol

Dihydrofolate Reductase Inhibitor Rx

This medicine contains sulfamethoxazole and trimethoprim. It is an antibiotic that fights bacteria in your body.

Drug Pricing (NADAC)

Generic Price

$1.36/unit

Generic Available

Yes (2 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine can treat urinary tract infections, ear infections in children, and bronchitis in adults.

Common side effects

Nausea, Vomiting, Loss of appetite

Key warnings

Rarely, sulfonamide drugs like this one have caused severe reactions.

How It Works

This medicine works by stopping bacteria from making folic acid. Bacteria need folic acid to grow and multiply. By blocking folic acid production, the medicine kills the bacteria.

How to Take It

Take this medicine exactly as your doctor tells you. For adults with urinary tract infections, the usual dose is 1 double-strength tablet or 2 regular tablets every 12 hours for 10 to 14 days. For children, the dose is based on weight. You can take this medicine with or without food.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. This medicine may not be safe for your baby. Talk to your doctor about the risks and benefits of taking this medicine while breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store this medicine at room temperature, away from heat and light.

Side Effects (from patient reports)

Based on 7,838 FDA adverse event reports.

Nausea
945
Off Label Use
868
Diarrhoea
848
Headache
835
Malaise
815
Drug Ineffective
746
Pyrexia
721
Dyspnoea
712
Vomiting
707
Fatigue
641

FDA Adverse Event Report Analysis

Detailed analysis of 11,380 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.

Total Reports

11,380

Death-Related Reports

1,472

Hospitalization Reports

4,968

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 7,000 (68%)
Male 3,220 (31%)

Age Distribution

0–17 477
18–44 1,863
45–64 2,189
65–74 1,878
75+ 2,547

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 945
2 OFF LABEL USE 868
3 DIARRHOEA 848
4 HEADACHE 835
5 MALAISE 816
6 DRUG INEFFECTIVE 746
7 PYREXIA 721
8 DYSPNOEA 712
9 VOMITING 708
10 FATIGUE 641
11 PAIN 605
12 RASH 605
13 DIZZINESS 599
14 ACUTE KIDNEY INJURY 594
15 URINARY TRACT INFECTION 555

Reactions in Death Reports

DEATH 241
DIARRHOEA 217
OFF LABEL USE 195
DYSPNOEA 180
VOMITING 177
PNEUMONIA 175
MALAISE 172
LOWER RESPIRATORY TRACT INFECTION 166
PYREXIA 157
CONDITION AGGRAVATED 156

Reactions in Hospitalization Reports

PYREXIA 556
DIARRHOEA 555
MALAISE 547
NAUSEA 516
VOMITING 496
OFF LABEL USE 437
DYSPNOEA 423
ACUTE KIDNEY INJURY 418
URINARY TRACT INFECTION 372
HEADACHE 369

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Rarely, sulfonamide drugs like this one have caused severe reactions. These include Stevens-Johnson syndrome, toxic epidermal necrolysis, liver damage, and blood problems. Tell your doctor right away if you have a fever, rash, blisters, mouth sores, or signs of infection.

Known Drug Interactions

albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline, s...

Mechanism: This medication has been shown to have no important effect on how quickly theophylline is cleared from your body.

What to do: You can take these together safely without a dose change, but tell your doctor if you feel any new side effects like nausea or jitters.

• L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. Caution should be exercised with the concomitant use of folinic acid and trimethoprim- sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo-controlled study.

Mechanism: Trimethoprim can lower the amount of folate, an important B-vitamin, in your blood. This can make the folate in your prenatal vitamin less effective.

What to do: Your doctor should use caution when prescribing these together and may need to monitor your vitamin levels.

Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim 7.2 Lithium Like other diuretics, spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity.

Mechanism: Both of these medications can cause your body to hold onto potassium. Taking them together increases the risk of having too much potassium in your blood.

What to do: Your doctor may need to monitor your potassium levels closely or adjust your doses.

Examples of drugs that can increase potassium include: • ACE inhibitors • angiotensin receptor blockers • non-steroidal anti-inflammatory drugs (NSAIDs) • heparin and low molecular weight heparin • trimethoprim 7.2 Lithium Like other diuretics, ALDACTONE reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity.

Mechanism: Both medications can cause potassium to build up in your body. This combination increases the risk of a condition called hyperkalemia, or high potassium.

What to do: Your doctor should monitor your potassium levels and may need to adjust your treatment plan.

Sulfamethoxazole and trimethoprim potentiates the effect of oral hypoglycemics 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). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported.

Mechanism: Trimethoprim can stop your kidneys from clearing metformin out of your body as fast as they should.

What to do: Your doctor may need to check your blood sugar more often or adjust your metformin dose.

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Common Questions

Can children take this medicine?
Children 2 months and older can take this medicine for certain infections.
What if I have kidney problems?
If you have kidney problems, your doctor may need to lower your dose.
Can this medicine interact with other drugs?
Yes, this medicine can interact with other drugs. Tell your doctor about all the medicines you take.
What should I avoid while taking this medicine?
Talk to your doctor about any specific foods or activities to avoid.
What are the symptoms of an allergic reaction?
Symptoms of an allergic reaction can include rash, hives, itching, swelling, and trouble breathing.
Can this medicine cause diarrhea?
Yes, this medicine can cause diarrhea. If you have severe diarrhea, tell your doctor.
How long does it take for this medicine to work?
This medicine usually starts working within a few days.
What if I have liver problems?
You should not take this medicine if you have severe liver damage.
Can this medicine cause anemia?
Yes, this medicine can sometimes cause anemia.
What do the tablet markings mean?
The tablets are marked with "H 48" or "H 49" and have a break line to help with splitting the tablet if needed.
What are the common side effects of trimethoprim?
The most commonly reported side effects of trimethoprim include Nausea, Vomiting, Loss of appetite, Skin rash, Hives. Based on 7,838 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does trimethoprim interact with other medications?
Yes, trimethoprim has 22 known drug interactions. Notable interactions include theophylline, prenatal multivitamin, spironolactone. Always inform your doctor about all medications you are taking.
What drug class is trimethoprim?
trimethoprim belongs to the Dihydrofolate Reductase Inhibitor drug class. It requires a prescription (Rx). This medicine can treat urinary tract infections, ear infections in children, and bronchitis in adults.
Is trimethoprim safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. This medicine may not be safe for your baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has trimethoprim been recalled?
There is 1 recall associated with trimethoprim products. Presence of a foreign substance. Check the recalls section below for full details and affected products.

Active Recalls

Class II August 18, 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLC

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What the FDA Data Shows for trimethoprim

The FDA label for trimethoprim (sold under brand names such as Primsol) classifies it as a prescription-only medication in the Dihydrofolate Reductase Inhibitor class. This medicine can treat urinary tract infections, ear infections in children, and bronchitis in adults. Official labeling lists 5 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 7,838 voluntary reports. The database also lists 22 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.36.

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 (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 17, 2024

All federal data sources used on this page