Primsol Oral Solution Side Effects
Please note - some side effects for Primsol Oral Solution may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Primsol Oral Solution Side Effects - for the Professional
Primsol Oral Solution
To report SUSPECTED ADVERSE REACTIONS, contact FSC Laboratories, Inc. at 1-866-764-7822, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Events Reported During Pediatric Clinical Trials With PRIMSOL
The following table lists those drug-related adverse events reported most frequently during the clinical trials in pediatric patients aged 6 months to 12 years. Most of these events were determined to be mild. The incidence of drug-related adverse events was significantly lower for PRIMSOL, which was most apparent for those events related to skin/appendages as a body system.
|Percent of Pediatric Patients|
|SMX + TMP*
|Body as a whole
An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with PRIMSOL or sulfamethoxazole + trimethoprim oral suspension.
Adverse Reactions Reported For Trimethoprim
In addition to the adverse events listed above which have been observed in pediatric patients receiving PRIMSOL, the following adverse reactions and altered laboratory tests have been previously reported for trimethoprim and therefore, may occur with PRIMSOL therapy:
Dermatologic reactions: pruritus and exfoliative dermatitis. At the recommended adult dosage regimens of 100 mg b.i.d., or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of trimethoprim in adults, an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.
Gastrointestinal reactions: Epigastric distress, nausea, and glossitis.
Hematologic reactions: Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia and methemoglobinemia.
Metabolic reactions: Hyperkalemia, hyponatremia.
Miscellaneous reactions: Fever, elevation of serum transaminase and bilirubin, and increases in BUN and serum creatinine levels.
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.