Omeprazole capsule is well tolerated and adverse reactions have generally been mild and reversible. The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate) - not necessarily inclusive:Those indicating need for medical attention: Incidence rare: Hematologic abnormalities, specifically anemia (unusual tiredness of weakness); eosinopenia; leukocytosis (sore throat and fever); neutropenia (continuing ulcers or sores in mouth); pancytopenia or thrombocytopenia (unusual bleeding or bruising); hematuria (bloody urine); proteinuria (cloudy urine); urinary tract infection (bloody or cloudy urine; difficult, burning, or painful urination; frequent urge to urinate).
Those indicating need for medical attention only if they continue or are bothersome: Incidence more frequent: Abdominal pain or colic.
Incidence less frequent: Asthenia (muscle pain; unusual tiredness); central nervous system (CNS) disturbances, specifically dizziness, headache, somnolence (unusual drowsiness); or unusual tiredness; chest pain; gastrointestinal disturbances, specifically acid regurgitation (heartburn); constipation; diarrhea or loose stools; flatulence (gas); or nausea and vomiting; skin rash or itching, urticaria and pruritus, paresthesia, insomnia and vertigo. Blurred vision, taste disturbance, peripheral oedema, increased sweating, gynaecomastia, bronchospasm, encephalopathy in patients with preexisting severe liver disease, hepatitis with or without jaundice, rarely interstitial nephritis and hepatic failure.
Increase in liver enzymes have been observed.
Subactute Cutaneous Lupus Erythematosus (SCLE): Skin and subcutaneous tissue disorders: Frequency not known: Subcutaneous lupus erythematosus.
Interstitial Nephritis: Renal and urinary disorders: lnterstitial nephritis.
Hypomagnesaemia: Metabolism and nutritional disorders: Frequency not known: hypomagnesaemia.
Fracture: Musculoskeletal disorders: Frequency uncommon: Fracture of the hip, wrist or spine.
Clostridium Difficile Diarrhea: Infection & infestations: Clostridium difficile associated diarrhea.
Fundic Gland Polyps: Gastrointestinal disorders: Frequency common: Fundic gland polyps (benign).
Vitamin B12 Deficiency: Metabolic/Nutritional: Vitamin B12 deficiency.