Koact 1000 Adverse Reactions

The following convention has been used for the classification of frequency: Very common: ≥1/10; Common: ≥1/100 and ≤1/10; Uncommon: ≥1/1,000 and ≤1/100; Rare ≥1/10,000 and ≤1/1,000; Very rare: ≤1/10,000.
Infections and infestations: Common: Mucocutaneous candidiasis.
Blood and Lymphatic system disorders: Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia.
Very rare: Reversible Agranulocytosis and hemolytic anemia, Prolongation of bleeding time and prothrombin time.
Immune system disorders: Very Rare: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.
Nervous system disorders: Rare: Dizziness, headache.
Very rare: Reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders: Adults: Very common: Diarrhea.
Common: Nausea, vomiting.
Children: Common: Diarrhea, nausea, vomiting.
Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking KOACT at the start of meals.
Rare: Indigestion.
Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis).
Superficial tooth discoloration has been reported very rarely.
Hepatobiliary disorders: Rare: A moderate rise in hepatic enzyme, AST and/or ALT.
Very rare: Hepatitis and cholestatic jaundice.
Hepatic events have been reported predominantly in males and elderly patients.
Signs and symptoms usually occur during treatment or until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and very rarely, deaths occurs. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
Skin and subcutaneous tissue disorders: Rare: Erythema multiforme Skin rashes, pruritus, urticaria.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP). If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued and consult the physicians.
Renal and urinary disorders: Very rare: Interstitial nephritis, crystalluria.