Drugs – U S Food and Drug Headache (7%) Abdominal pain (5%) Diarrhea (4%) Nausea (4%) Vomiting (3%) Flatulence (3%) Dizziness (2%) Upper respiratory infection (2%) Acid regurgitation (2%) Constipation (2%) Rash (2%) Cough (1%) Fracture of bone, osteoporosis-related Hepatotoxicity (rare) Agranulocytosis Anorexia Gastric polyps Hip fracture Alopecia Atrophic gastritis Interstitial nephritis (rare) Pancreatitis (rare) Rhabdomyolysis Taste perversion Abnormal dreams Toxic epidermal necrolysis (rare) PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve May require dosage reduction with liver disease Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than mediy indicated; discontinue if sns or symptoms consistent with CLE or SLE are observed and refer patient to specialist Shown to cause gastric carcinoid tumors in rats with increased doses, but risk in humans unconfirmed Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued Decreased gastric acidity increases serum chromogranin A (Cg A) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing Cg A levels Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin Acute interstitial nephritis has been observed in patients taking PPIs Relief of symptoms does not eliminate the possibility of a gastric malnancy Therapy increases risk of Salmonella, Campylobacter, and other infections May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with hh dose methotrexate administration Metabolized extensively by hepatic CYP2C19; slow metabolizers are deficient in CYP2C19 enzyme system; plasma concentration can increase by 5-fold or hher in comparison with that found in persons with the enzyme Metabolites: Hydroxyomeprazole, omeprazole sulfone, omeprazole sulfide (inactive) Enzymes inhibited: CYP2C19 The above information is provided for general informational and educational purposes only. Emergency Preparedness. Bioterrorism, drug preparedness and natural disaster response. Drug Approvals and Databases. Drug-Related Databases from FDA; Information on.
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