Symptomatic response to therapy does not preclude the presence of gastric malignancy in adults. Risk of acute tubulointerstitial nephritis. Increased risk of GI infections &
Clostridium difficile-associated diarrhea. Increased risk for osteoporosis-related fractures of the hip, wrist or spine in patients who received high-dose (multiple daily doses) & long-term (≥1 yr) therapy. Reports of severe cutaneous adverse reactions, including SJS, TEN, DRESS, & acute generalized exanthematous pustulosis; cutaneous lupus erythematosus & SLE. Daily treatment w/ any acid-suppressing medications over a long period of time (eg, >3 yr) may lead to malabsorption of cyanocobalamin (vit B
12). Consider monitoring Mg & Ca levels prior to treatment initiation & periodically while on treatment in patients w/ pre-existing risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps that increases w/ long-term use (especially >1 yr). Interactions w/ investigations for neuroendocrine tumors. Concomitant use w/ high-dose MTX. Not recommended in patients w/ severe hepatic impairment (Child-Pugh class C); in ped patients <2 yr; for treatment of symptomatic GERD in ped patients 1 mth to <1 yr of age. Safety & effectiveness have not been established in ped patients <12 yr. Advise pregnant women of potential risk to fetus. Consider benefits of breastfeeding along w/ mother's clinical need for treatment & any potential adverse effects on breastfed child.