Ganaton Adverse Reactions

The following undesirable effects have been experienced with the indicated frequencies as follows in 998 itopride-treated patients in 4 placebo-controlled, 4 reference-controlled, and 13 uncontrolled company sponsored interventional clinical trials with a standard daily itopride dose of 150 mg or lower [common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100)]. No ADRs in the categories very common (≥1/10), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000) were identified. (See table.)

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ADR - Post Marketing Experience: The following adverse events have been reported spontaneously during post marketing use. A precise frequency cannot be estimated from the available data.
Blood and lymphatic system disorders: Leukopenia and thrombocytopenia.
Immune system disorders: Hypersensitivity, including Anaphylactoid reaction.
Endocrine disorders: Blood prolactin increased.
Nervous system disorders: Dizziness, headache, and tremor.
Gastrointestinal disorders: Diarrhea, constipation, abdominal pain, salivary hypersecretion, and nausea.
Hepato-biliary disorders: Jaundice.
Skin and subcutaneous tissue disorders: Rash, Erythema and Pruritus.
Reproductive system and breast disorders: Gynecomastia.
Investigations: Aspartate aminotransferase increased, Alanine aminotransferase increased, Gamma-glutamyltransferase increased, Blood alkaline phosphatase increased and Blood bilirubin increased.