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Adverse Reactions (Pediatric)

In controlled clinical trials in pediatric patients (age 2 to 18 years), nizatidine was found to be generally safe and well tolerated. The principal adverse experiences (> 5%) were pyrexia, nasopharyngitis, diarrhea, vomiting, irritability, nasal congestion and cough. Most adverse events were mild or moderate in severity. Mild elevations in serum transaminase (1-2 x ULN) were noted in some patients. One subject experienced a seizure by EEG diagnosis after taking Axid® Oral Solution 2.5 mg/kg BID for 23 days. The adverse reactions reported for nizatidine may also occur with Axid® Oral Solution.