Adverse Drug Reactions

Rabeprazole sodium (PARIET®) tablets were generally well-tolerated during clinical trials. The observed undesirable effects have generally been mild/moderate and transient in nature and consistent between adults and adolescents. The most common adverse events are headache, diarrhea and nausea. Adverse reactions reported as more than isolated cases are listed below by system organ class and by frequency.

The following adverse events have been reported from clinical trial and post-marketed experience. However of those adverse reactions reported in company sponsored clinical trials, only headache, diarrhea, abdominal pain, asthenia, flatulence, rash and dry mouth were associated with the use of Rabeprazole sodium (PARIET®) Tablets. Frequencies are defined as: common (> 1/100, < 1/10), uncommon (> 1/1 ,000, < 1/100) rare (> 1/10,000, < 1000) and very rare (< 1/10,000).

System Organ Class Common Uncommon Rare Very Rare Not Known
Infections and infestations Infection
Blood and the lymphatic system
Neutropenia, Leucopenia,
Thrombocytopenia, Leucocytosis
Immune system disorders Hypersensitivity1,2
Metabolism and nutrition disorders Anorexia, Hypomagnesemia Hyponatremia
Psychiatric disorders Insomnia Nervousness Depression Confusion
Nervous system disorders Headache, Dizziness Somnolence
Eye disorders Visual disturbance
Vascular disorders Peripheral edema
Respiratory, thoracic and
mediastinal disorders
Cough, Pharyngitis,
Bronchitis, Sinusitis
Gastrointestinal disorders Diarrhea, Vomiting, Nausea, Abdominal Pain, Constipation, Flatulence Dyspepsia, Dry mouth, Eructation Gastritis, Stomatitis, Taste
Hepato-biliary disorders Hepatitis, Jaundice, Hepatic encephalopathy3
Skin and subcutaneous tissue
Rash, Erythema2 Pruritus, Sweating, Bullous reactions2 Erythema multiforme, toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS)
Musculoskeletal, connective tissue and bone disorders Non-specific pain, Back pain Myalgia, Leg cramps, Arthralgia
Renal and urinary disorders Urinary tract infection lnterstitial nephritis
Reproduction system and breast
General disorders and
administration site conditions
Asthenia, Flu-like syndrome Chest pain, Chills, Fever
lnvestigations Increased hepatic enzymes3 Weight gain
1 Includes facial swelling, hypotension and dyspnea
2 Erythema, bullous reactions and hypersensitivity reactions have usually resolved after discontinuation of therapy.
3 Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. In treatment of patients with severe
hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole sodium (PARIET®) is first initiated in such patients

Reporting of suspected adverse drug reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: