Sulfatrim Pediatric Side Effects

Generic name: sulfamethoxazole / trimethoprim

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

Note: This document provides detailed information about Sulfatrim Pediatric Side Effects associated with sulfamethoxazole / trimethoprim. Some dosage forms listed on this page may not apply specifically to the brand name Sulfatrim Pediatric.

Applies to sulfamethoxazole / trimethoprim: oral suspension, oral tablet.

Other dosage forms:

• intravenous solution

Serious side effects of Sulfatrim Pediatric

Along with its needed effects, sulfamethoxazole / trimethoprim may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulfamethoxazole / trimethoprim:

Other side effects of Sulfatrim Pediatric

Some side effects of sulfamethoxazole / trimethoprim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), or acute febrile neutrophilic dermatosis (AFND). Check with your doctor if you have a skin rash, blistering, peeling, loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, white spots in the mouth or on the lips, black, tarry stools, chest pain, or painful or difficult urination.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

This medicine, especially if you are receiving high doses or for a long period of time, may lower the number of platelets in your body, which are necessary for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have black, tarry stools, bleeding gums, blood in urine or stools, pinpoint red spots on the skin, unusual bleeding or bruising.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you Stop taking sulfamethoxazole / trimethoprim. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child have stomach cramps, bloating, watery and severe diarrhea, which may also be bloody, nausea or vomiting, or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you use the medicine.

This medicine may cause electrolyte problems, including high potassium in the blood (hyperkalemia) and low sodium in the blood (hyponatremia). Tell your doctor right away if you have confusion, weakness, muscle twitching, an irregular heartbeat, numbness or tingling in the hands, feet, or lips, or trouble breathing.

This medicine may cause hypoglycemia (low blood sugar) in some patients. Check with your doctor if you have anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Patients receiving anticonvulsant treatment (medicines to prevent seizures) may be at risk for a folate (vitamin B9) deficiency, which may increase the risk for side effects. Talk with your doctor if you have concerns about this.

Do not use this medicine if you are also using dofetilide (Tikosyn®).

Do not use this medicine for Pneumocystis jiroveci pneumonia (PCP) if you are also using leucovorin. Using these medicines together may cause these medicines to not work as well for you.

Do not take other medicines unless they have been discussed with your doctor. This includes leucovorin, other prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to sulfamethoxazole / trimethoprim: intravenous solution, oral suspension, oral tablet.

General adverse events

The most common side effects were gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (e.g., rash, urticaria).

Effects associated with Pneumocystis jirovecii pneumonia management have included severe hypersensitivity reactions, rash, pyrexia, neutropenia, thrombocytopenia, elevated liver enzymes, hyperkalemia, hyponatremia, and rhabdomyolysis; such effects were very rare.

Although rare, fatalities associated with sulfonamide use have occurred due to severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood dyscrasias, and respiratory hypersensitivity.^[Ref]

Metabolic

• Very common (10% or more): Hyperkalemia
• Frequency not reported: Anorexia, hypoglycemia, hyponatremia, decreased appetite
• Postmarketing reports: Metabolic acidosis^[Ref]

Hypoglycemia has been reported in patients using sulfonamides.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea
• Uncommon (0.1% to 1%): Vomiting
• Frequency not reported: Glossitis, stomatitis, pseudomembranous enterocolitis, pancreatitis, emesis, abdominal pain, pseudomembranous colitis, Clostridium difficile-associated diarrhea, constipation, sore mouth^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Aseptic meningitis, convulsions/seizures, peripheral neuritis/neuropathy, ataxia, dizziness, vertigo, tinnitus, tremor, other neurological manifestations (e.g., ataxia, ankle clonus, apathy), lethargy, paresthesia, syncope^[Ref]

Aseptic meningitis was rapidly reversible when this drug was stopped but recurred in several cases upon re-exposure to either this combination drug or to trimethoprim alone.

Tremor and other neurological manifestations (e.g., ataxia, ankle clonus, apathy) occurred during therapy with this drug in several patients with AIDS; although such effects have also been associated with the underlying disease process, these symptoms resolved within 2 to 3 days after stopping this drug.^[Ref]

Dermatologic

• Common (1% to 10%): Rash
• Frequency not reported: Diffuse rash, erythematous rash, maculopapular rash, morbilliform rash, pruritic rash, urticaria, photosensitivity, pruritus, exfoliative dermatitis, fixed drug eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Henoch-Schonlein purpura, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized skin eruptions, purpura, angioedema, generalized pustular dermatosis, alopecia, allergic/hypersensitivity vasculitis resembling Henoch-Schonlein purpura, erythema nodosum, bullous dermatitis^[Ref]

Other

• Common (1% to 10%): Fungal/monilial overgrowth
• Frequency not reported: Drug fever, chills, weakness, fatigue, abnormal elevations in alkaline phosphatase, positive lupus erythematous phenomenon, moniliasis^[Ref]

Cardiovascular

• Frequency not reported: Thrombophlebitis, allergic myocarditis, polyarteritis/periarteritis nodosa
• Postmarketing reports: QT prolongation (resulting in ventricular tachycardia and torsade de pointes)^[Ref]

Hematologic

• Frequency not reported: Leucopenia, neutropenia, thrombocytopenia, bone marrow depression, agranulocytosis, aplastic anemia, hemolytic anemia, megaloblastic anemia, methemoglobinemia, hypoprothrombinemia, eosinophilia, hematological toxicity, hemolysis, pancytopenia, granulocytopenia
• Postmarketing reports: Thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura^[Ref]

Severe cases of thrombocytopenia that were fatal or life-threatening have been reported. Thrombocytopenia generally resolved within a week when this drug was discontinued.

Hemolysis has been reported in certain susceptible glucose-6-phosphate deficient patients.^[Ref]

Hepatic

• Frequency not reported: Hepatitis, cholestatic jaundice, hepatic necrosis, elevated serum transaminase, elevated bilirubin, hepatic changes, abnormal elevations in serum transaminase levels, jaundice, elevated liver enzymes, disturbance in liver enzymes^[Ref]

Cases of cholestatic jaundice and hepatic necrosis have been fatal.

Jaundice (generally mild and transient) has been reported rarely, often occurring in patients with history of infectious hepatitis.^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity, allergic skin reactions, anaphylaxis, serum sickness-like syndrome, generalized allergic reactions, anaphylactic/anaphylactoid reactions, severe hypersensitivity reactions (including associated with P jirovecii pneumonia), serum sickness^[Ref]

Local

• Frequency not reported: Local reaction, pain, slight/local irritation, inflammation^[Ref]

Local reaction, pain, and slight irritation were reported infrequently with IV administration.^[Ref]

Musculoskeletal

• Frequency not reported: Arthralgia, myalgia, rhabdomyolysis, systemic lupus erythematosus, muscle weakness^[Ref]

Rhabdomyolysis has been reported with this drug, primarily in patients with AIDS.^[Ref]

Ocular

• Frequency not reported: Uveitis, conjunctival and scleral injection/redness/edema, periorbital edema, corneal ring infiltrates, vision problems^[Ref]

Psychiatric

• Frequency not reported: Depression/mental depression, hallucinations, apathy, nervousness, insomnia, psychotic disorder, confusional state, agitation, anxiety, abnormal behavior, nightmares^[Ref]

Renal

• Frequency not reported: Renal impairment/failure, interstitial nephritis, tubulointerstitial nephritis and uveitis syndrome, elevated BUN, elevated serum creatinine, toxic nephrosis, renal tubular acidosis, nephrotoxicity, functional kidney changes, abnormal elevations in serum urea, abnormal elevations in serum creatinine, stone formation, tubular necrosis, aggravation of renal disease, azotemia, hyperkalemic renal tubular acidosis, overestimations of normal creatinine values^[Ref]

Nephrotoxicity has been reported in association with cyclosporine.^[Ref]

Genitourinary

• Frequency not reported: Oliguria, anuria, crystalluria, diuresis, dysuria, hematuria, urgency changes, abnormal elevations in urine protein levels^[Ref]

Diuresis has been reported in patients using sulfonamides.^[Ref]

Respiratory

• Frequency not reported: Cough, dyspnea/shortness of breath, pulmonary infiltrates/lung infiltration, epistaxis, eosinophilic/allergic alveolitis, wheezing^[Ref]

Cough, dyspnea, and lung infiltration have been early indicators of respiratory hypersensitivity which, while very rare, has been fatal.^[Ref]

See also:

Frequently asked questions

• What drugs should be avoided with a sulfa allergy?
• Does Bactrim cause headaches?
• Can I drink alcohol when taking sulfamethoxazole / trimethoprim DS?
• What dose of co-trimoxazole is used in a patient with a UTI?

Further information

Sulfatrim Pediatric side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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