In clinical trials (phase I-III), itopride hydrochloride was well-tolerated and no serious adverse reactions were reported. A total of 19 adverse drug reactions in 14 patients were reported out of 572 cases with an incidence of 2.4%. The majority of these adverse reactions occurring in >1 patient consisted of diarrhea in 4 cases (0.7%), headache in 2 cases (0.3%) and abdominal pain in 2 cases (0.3%).
Abnormal laboratory findings observed in the trials include decreased white blood cells (leukocytopenia) in 4 cases (0.7%), increased prolactin in 2 cases (0.3%).
Post Marketing Experience:
The following adverse events have been reported in patients receiving itopride hydrchloride.
Blood and Lymphatic System Disorders:
Leukopenia and thrombocytopenia.
Immune System Disorders:
Increased prolactin level and gynecomastia.
Nervous System Disorders:
Dizziness, headache and tremor.
Diarrhea, constipation, abdominal pain, increased saliva and nausea.
Skin and Subcutaneous Tissue Disorders:
Rash, redness and itching.
Increased aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase (SGOT)], alanine aminotransferase (ALT) [serum glutamic pyruvic transaminase (SGPT)], γ-glutamyl transpeptidase (γ-GTP), alkaline phosphatase and bilirubin.