Amoclav Suspension Adverse Reactions

156.25 mg/5 mL & 312.5 mg/5 mL powder for oral suspension: The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic acid, 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). (See Table 13.)

Click on icon to see table/diagram/image

228.5 mg/5 mL & 457 mg/5 mL powder for suspension and 642.9 mg/5 mL powder for oral suspension: The most frequently reported adverse effects with co-amoxiclav include diarrhea, nausea and vomiting.
Infections and infestations: Mucocutaneous candidiasis, overgrowth of non-susceptible organisms.
Blood and lymphatic system disorders: Agranulocytosis, anemia, bleeding time prolonged, hemolytic anemia, eosinophilia, leukopenia, neutropenia, prothrombin time prolonged, thrombocytopenia, thrombocytopenia purpura.
Immune system disorders: Anaphylactic reaction, anaphylaxis, angioneurotic edema, serum sickness-like syndrome.
Metabolism and nutrition disorders: Anorexia.
Psychiatric disorders: Abnormal behavior, anxiety, reversible hyperactivity.
Nervous system disorders: Agitation, aseptic meningitis, confusion, convulsions, dizziness, headache, insomnia, reversible hyperactivity.
Vascular disorders: Hypersensitivity vasculitis.
Gastrointestinal disorders: Abdominal discomfort, black hairy tongue, Clostridium difficile-associated diarrhea and colitis, hemorrhagic colitis, dyspepsia, enterocolitis, flatulence, gastritis, glossitis, indigestion, pseudomembranous colitis stomatitis, tooth discoloration (brown, yellow or gray staining which is very rare in children).
Hepatobiliary disorders: Cholestatic jaundice, hepatic dysfunction, hepatitis, hepatitis cholestatic, hepatic coma, hepatic failure, increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and serum bilirubin, hepatocellular damage, jaundice, liver injury.
Skin and subcutaneous tissue disorders: Acute generalized exanthemous pustulosis (AGEP), bullous exfoliative-dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, hypersensitivity vasculitis, maculopapular rash, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Renal and urinary disorders: Crystalluria, hematuria, interstitial nephritis.
Reproductive system and breast disorders: Vaginitis.
General disorders and administration site conditions: Fever.