PARIET tablets were generally well tolerated during clinical trials of adult and adolescents. The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature and consistent between adults and adolescents.
The following adverse events have been reported from clinical trial and post-marketed experience (see table).
Frequencies are defined as: Common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000).
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There have been post-marketing reports of bone fractures (see Precautions).