OTC Omeprazole Side-effects

• OTC AEs similar to Rx AEs
  • Headache (439 cases), Infection (190 cases), Diarrhea (167 cases)
  • Serum sickness (1 case), urticaria (4 cases) and elevations of AST (7 cases)

• No dose-related differences

• Drug discontinuation - headache n=10; rash n= 3

• 2 deaths unrelated to drug

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