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 disorders |
Neutropenia, Leucopenia, Thrombocytopenia, Leucocytosis |
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| 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, Rhinitis |
Bronchitis, Sinusitis | |||
| Gastrointestinal disorders | Diarrhea, Vomiting, Nausea, Abdominal Pain, Constipation, Flatulence | Dyspepsia, Dry mouth, Eructation | Gastritis, Stomatitis, Taste disturbance |
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| Hepato-biliary disorders | Hepatitis, Jaundice, Hepatic encephalopathy3 | ||||
| Skin and subcutaneous tissue disorders |
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 disorders |
Gynecomastia | ||||
| 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 |
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| 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: www.fda.gov.ph |