Rabeprazole Sandoz Adverse Reactions

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.
The following adverse events have been reported from clinical trial and post-marketing experience.
Frequencies are defined as: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Infections and infestations: Common: Infection.
Blood and the lymphatic system disorders: Rare: Neutropenia, leucopenia, thrombocytopenia, leucocytosis.
Immune system disorders: Rare: Hypersensitivity^1,2.
Metabolism and nutrition disorders: Rare: Anorexia.
Not known: Hyponatraemia, hypomagnesaemia (see Precautions).
Psychiatric disorders: Common: Insomnia.
Uncommon: Nervousness.
Rare: Depression.
Not known: Confusion.
Nervous system disorders: Common: Headache, dizziness.
Uncommon: Somnolence.
Eye disorders: Rare: Visual disturbance.
Vascular disorders: Not known: Peripheral oedema.
Respiratory, thoracic and mediastinal disorders: Common: Cough, pharyngitis, rhinitis.
Uncommon: Bronchitis, sinusitis.
Gastrointestinal disorders: Common: Diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence, fundic gland polyps (benign).
Uncommon: Dyspepsia, dry mouth, eructation.
Rare: Gastritis, stomatitis, taste disturbance.
Not known: Microscopic colitis.
Hepatobiliary disorders: Rare: Hepatitis, jaundice, hepatic encephalopathy³.
Skin and subcutaneous tissue disorders: Uncommon: Rash, erythema².
Rare: Pruritus, sweating, bullous reactions².
Very rare: Erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS).
Not known: Subacute cutaneous lupus erythematosus (see Precautions).
Musculoskeletal, connective tissue and bone disorders: Common: Non-specific pain, back pain.
Uncommon: Myalgia, leg cramps, arthralgia, fracture of the hip, wrist or spine (see Precautions).
Renal and urinary disorders: Uncommon: Urinary tract infection.
Rare: Interstitial nephritis.
Reproductive system and breast disorders: Not known: Gynaecomastia.
General disorders and administration site conditions: Common: Asthenia, influenza like illness.
Uncommon: Chest pain, chills, pyrexia.
Investigations: Uncommon: Increased hepatic enzymes³.
Rare: Weight increased.
¹ Includes facial swelling, hypotension and dyspnoea.
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 is first initiated in such patients (see Precautions).