Klacid/Klacid MR Adverse Reactions

The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics.
There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.
The following table displays adverse reactions reported in clinical trials and from post-marketing experience with Klacid immediate release, granules for oral suspension, IV and MR.
The reactions considered at least possibly related to clarithromycin are displayed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed.
Klacid/Klacid Forte, Klacid Pediatric Suspension and Klacid IV: (See Table 6.)

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Klacid/Klacid Forte and Klacid IV: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Klacid MR: (See Table 7.)

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Klacid/Klacid Forte, Klacid MR and Klacid IV: Immunocompromised Patients: In AIDS and other immunocompromised patients treated with the higher doses of clarithromycin over long periods of time for mycobacterial infections, it was often difficult to distinguish adverse events possibly associated with clarithromycin administration from underlying signs of HIV disease or intercurrent illness.
In adult patients, the most frequently reported adverse events by patients treated with total daily doses of 1000 mg of clarithromycin were: nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing disturbance, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) elevations. Additional low-frequency events included dyspnea, insomnia, and dry mouth.
In these immunocompromised patients evaluations of laboratory values were made by analyzing those values outside the seriously abnormal level (i.e., the extreme high or low limit) for the specified test. On the basis of this criteria, about 2 to 3% of these patients who received 1000 mg of clarithromycin daily had seriously abnormal elevated levels of SGOT and SGPT, and abnormally low white blood cell and platelet counts. A lower percentage of patients also had elevated BUN levels.
Klacid Pediatric Suspension: 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.
A limited number of pediatric AIDS patients have been treated with Klacid Pediatric Suspension for mycobacterial infections. 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 (i.e., the extreme high or low limit) for the specified test. Based on these criteria, one pediatric AIDS patient receiving <15 mg/kg/day of clarithromycin had a seriously abnormal (elevated) total bilirubin; of the patients receiving 15 to <25 mg/kg/day of clarithromycin, there was one each reported as seriously abnormal SGPT, BUN, and seriously decreased platelet count. None of these seriously abnormal values for these laboratory parameters were reported for patients receiving the highest dosage (≤25 mg/kg/day) of clarithromycin.