Pharmaniaga Clarithromycin Adverse Reactions

After oral administration of clarithromycin, some cases of G.I disturbances have been reported (nausea, vomiting, heartburns, abdominal pain, diarrhoea), headache and skin rashes. Other adverse reactions reported include stomatitis, glossitis, oral monilia, taste perversion, pseudomembranous colitis.
Transient CNS events including anxiety, behavioural changes, confusional states, depersonalisation, disorientation, hallucinations, insomnia, manic behaviour, nightmares, psychosis, tinnitus, tremor, and vertigo have been reported during post-marketing surveillance. Events usually resolve with discontinuation ofthe drug.
Hepatic dysfunction, including increased liver enzymes and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.
There have been rare reports of hypoglycaemia, some of which have occurred in patients taking oral hypoglycaemic agents or insulin. Rarely, erythromycin and clarithromycin have been associated with ventricular arrhythmias including ventricular tachycardia and Torsade de pointes, in individuals with prolonged QTc intervals.
Skin and subcutaneous Tissue Disorders: Frequency not known: severe cutaneous adverse reactions (SCARs) including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) & acute generalised exanthematous pustulosis (AGEP).
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 analysing those values outside the seriously abdominal level (eg, the extreme high or low limit) for the specified test. Based on these criteria, one paediatric AIDS patient receiving <15 mg/kg/day of clarithromycin had 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 received the highest dosage (≥25 mg/kg/day) of clarithromycin.