Clariget/Clariget OD: Clarithromycin is generally well tolerated.
The most frequently reported side effects of clarithromycin in clinical studies were GI-related ie, nausea, dyspepsia, abdominal pain, vomiting and diarrhea. Other reported side effects include headache, taste perversion and transient elevations of liver enzymes.
Headache and rashes from mild skin eruptions to rarely, Stevens-Johnson syndrome have occurred. There have also been reports of transient CNS effects eg, anxiety, dizziness, insomnia, hallucinations and confusion.
Other adverse effects include hypoglycemia and thrombocytopenia. Interstitial nephritis, renal failure, hearing loss, glossitis, stomatitis, oral monilia and tongue discoloration have been reported with clarithromycin therapy.
Adverse Laboratory Changes: Abnormal liver function test results may occur following therapy with clarithromycin. Changes in laboratory parameters without regard to drug relationship are: Hepatic: Elevated SGPT (ALT), SGOT (AST), GGT, alkaline phosphates, LDH, bilirubin.
Hematologic: Decreased WBC, prothrombin time.
Renal: Elevated BUN, serum creatinine.
Clariget: The safety profile of the pediatric formulation is similar to that of the 250-mg tablet in adult patients.
Hematologic: Decreased platelet count. Elevated prothrombin.
Immunocompromised Pediatric Patients: In AIDS and other immunocompromised patients treated with the higher doses of clarithromycin over long periods of time for mycobacterial infections, it is often difficult to distinguish adverse events possibly associated with clarithromycin administration from underlying signs of HIV disease or intercurrent illness.
The most frequently reported adverse events, excluding those due to the patient's concurrent condition, were tinnitus, deafness, vomiting, nausea, abdominal pain, purpuric rash, pancreatitis and increased amylase. Evaluations of laboratory values for these patients were made by analyzing those values outside the seriously abnormal level (ie, the extremely high or low limit) for the specified test. None of these seriously abnormal values for these laboratory parameters were reported for patients receiving the highest dosage (25 mg/kg/day) of clarithromycin.