a) Hypersensitivity: Anaphylactic reactions* (generalized rash, facial edema, dyspnea, etc.) may rarely occur, and shock has consequently occurred in certain cases. Toxic epidermal necrolysis* (Lyell syndrome) and oculomucocutaneous syndrome (Stevens-Johnson syndrome*) may occur. Therefore, close observation should be made, and if any abnormality is observed, PREVACID FDT should be discontinued and appropriate measures taken. Rash and pruritus may infrequently occur.
b) Hepatic: Severe hepatic dysfunction with jaundice, hepatitis, etc., may rarely occur. Therefore, close observation should be made. If any abnormality is observed, PREVACID FDT should be discontinued and appropriate measures taken. The elevation of GOT, GPT, alkaline-P, LDH or γ-GTP may infrequently occur.
c) Blood: Agranulocytosis*, pancytopenia* or hemolytic anemia may rarely occur. Anemia, leucopenia*, eosinophilia or thrombocytopenia* may infrequently occur. Therefore, close observation should be made, and if any abnormality is observed, such appropriate measures as discontinuation of PREVACID FDT should be taken.
d) Gastrointestinal: Constipation, diarrhea, dry mouth or abdominal distension may infrequently occur. Nausea, vomiting, microscopic colitis*, anorexia, Fundic gland polyps (benign), abdominal pain, candidiasis, stomatitis, glossitis or taste abnormality may rarely occur. With the exception of patients being treated for the eradication of Helicobacter pylori infection, if diarrhea persists, administration of PREVACID FDT should be discontinued, due to the possibility of microscopic colitis with thickening of the collagen bundle or infiltration of inflammatory cells noted in the large intestine submucosa. In majority of cases, symptoms of microscopic colitis resolve on discontinuation of PREVACID FDT. Serious colitis accompanied with bloody stools, such as pseudomembranous colitis, may occur due to amoxicillin or clarithromycin being used for Helicobacter pylori eradication. If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment, should be taken. Heartburn and gastroesophageal reflux were observed (<1%) in the clinical studies on Helicobacter pylori eradication.
e) Psychoneurotic: Headache or sleepiness may infrequently occur. Depressed state, insomnia, dizziness or tremor may rarely occur.
f) Metabolism and nutrition disorders: Hyponatremia*, Hypomagnesaemia* (frequency 'not known'), vitamin B12 deficiency, Hypocalcemia*ϯ and Hypokalemia*ϯ
g) Renal: Tubulointerstitial nephritis (TIN) (with possible progression to renal failure), interstitial nephritis.
h) Musculoskeletal disorders (frequency "uncommon"): Fracture of the hip, wrist or spine.
i) Skin and subcutaneous tissue disorders: Rash, Pruritus, Cutaneous lupus erythematosus*, Steven-Johnson Syndrome*, Toxic Epidermal Necrolysis*, Drug reaction with eosinophilia and systemic symptoms (DRESS)*, Acute generalized exanthematous pustulosis*, Erythema multiforme*, Subacute cutaneous lupus erythematosus (SCLE)*(frequency 'not known').
j) Infections and infestations: Clostridium difficile associated diarrhea.
k) Others: Interstitial pneumonia may rarely occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed such examinations as chest X-ray should immediately be performed, and PREVACID FDT should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken. Fever or elevation of total cholesterol and uric acid may infrequently occur. Gynecomastia, blurred vision, edema, weakness, malaise, numbness of tongue or lips, numbness of limbs, arthralgia, muscle pain or alopecia may rarely occur. Increased triglyceride, positive urinary protein, or positive urine sugar were observed (1-5%) in the clinical studies on Helicobacter pylori eradication.
ϯHypocalcemia and/or hypokalemia may be related to the occurrence of hypomagnesemia (see PRECAUTIONS).