Alclav Neo/Alclav Kids/Alclav Hospi Adverse Reactions

Alclav Neo 625 mg/Alclav Kids/Alclav Hospi: The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with co-amoxiclav, sorted by MedDRA System Organ Class are listed as follows.
The following terminologies have been used in order to classify the occurrence of undesirable effects. Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Alclav Neo 625 mg/Alclav Hospi: (See Table 10).

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Alclav Kids: See Table 11.

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Alclav Neo 1g: Gastrointestinal Reactions: Gastritis, stomatitis, glossitis, black "hair" tongue, indigestions, nausea, vomiting, diarrhea, enterocolitis, pseudomembranous colitis and candidiasis have been reported.
Hypersensitivity Reactions: Skin rashes and urticaria have been reported. These reactions may be controlled with antihistamines and if necessary, systemic corticosteroids. Rare cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and an occasional case of exfoliative dermatitis have been reported.
Interstitial nephritis can occur rarely. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema have been reported in patients on penicillin therapy. Cross-sensitivity with other beta-lactam antibiotics e.g., cephalosporins, may occur.
Hepatic Effects: As with some other antibacterial agents, a few cases of transient hepatitis and cholestatic jaundice have been reported.
Haematologic Effects: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins.
Local Reactions: Phlebitis at the site of injection has also been reported.