Pharmaniaga Co-Amoxiclav Adverse Reactions

Adverse effects are uncommon, and mainly of a mild and transitory nature. Diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal adverse effects occur with oral therapy, these may be reduced by taking the drug at the start of meals.
Hepatitis and cholestatic jaundice have been reported rarely with amoxicillin/clavulanate. However, may be severe and continue for several months. These are reported as occurring predominantly in adult or elderly patients and slightly more frequent in males.
Signs and symptoms may occur during treatment but are more frequently reported after cessation of therapy with a delay of up to 6 weeks. The hepatic events are usually reversible. However, in extremely rare circumstances deaths have been reported. Urticarial and erythematous rashes sometimes occur.
Rarely, erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rash appears. In common with other β-lactam antibiotics, angioedema and anaphylaxis have been reported.
Interstitial nephritis and hematuria can occur rarely. As with other antibiotics the incidence of gastrointestinal side effects may be raised in children <2 years. In clinical trials, however, only 4% of children <2 years were withdrawn from treatment. As with other β-lactams, transient leukopenia, thrombocytopenia and hemolytic anemia have been reported rarely.
The following adverse reactions have been reported for ampicillin class antibiotics: Haemic and Lymphatic Systems: Anemia eg, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in <1% of the patients treated with amoxicillin/clavulanate. There have been reports of increased prothrombin time in patients receiving amoxicillin/clavulanate and anticoagulant therapy concomitantly.
Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia and reversible hyperactivity have been reported rarely.
Superficial tooth discoloration has been reported which can be removed by brushing.