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 11.)

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228.5 mg/5 mL & 457 mg/5 mL suspension: Dermatologic and Hypersensitivity Reactions: Angioneurotic edema, anaphylaxis, serum sickness-like syndrome, fever, hypersensitivity vasculitis, skin rash, pruritus, urticaria, angioedema, erythema multiforme (rarely Stevens-Johnson syndrome), toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP).
Gastrointestinal Effects: Abdominal discomfort, anorexia, and flatulence, dyspepsia, diarrhea/loose stools, nausea, vomiting, indigestion, Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis), gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis.
Hematologic Effects: Reversible leukopenia (including neutropenia) and thrombocytopenia, thrombocytopenic purpura, reversible agranulocytosis, anemia (including hemolytic anemia), slight thrombocytosis, eosinophilia, abnormal platelet aggregation, prolonged bleeding time and prothrombin time.
Nervous System Effects: Dizziness, headache, reversible hyperactivity and convulsions particularly in patients with impaired renal functions or those receiving high doses, agitation, anxiety, behavioral changes, confusion, insomnia.
Hepatic Effects: A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), serum bilirubin and/or alkaline phosphatase, hepatitis, cholestatic jaundice, acute hepatic dysfunction.
Renal and Genitourinary Effects: Acute interstitial nephritis, crystalluria, vaginal itching, soreness and discharge.
Other Effects: Superficial tooth discoloration (brown, yellow, or gray staining).