Proton-pump inhibitors are widely used for the treatment of acid-related disorders and for prophylaxis. Generally considered safe, these medications are available over the counter in the United States. Although the most common adverse reactions are mild-including headache, nausea, and stomachache-there is growing evidence that proton-pump inhibitors may be associated with more serious renal, cardiovascular, autoimmune, and neurologic adverse effects.

Using postmarketing safety data, researchers evaluated the frequency of reported adverse events related to kidney injury and electrolyte disturbances in patients taking proton-pump inhibitors. The researchers reviewed more than 10 million reports from the Food and Drug Administration Adverse Event Reporting System on patients who used proton-pump inhibitors or histamine-2 receptor antagonists with no other concurrent medications.

The researchers found that the frequency of renal adverse event reports were significantly increased in cases of monotherapy with proton-pump inhibitors compared with histamine-2 receptor antagonists. The composite renal adverse drug reaction frequency was 5.6% of proton-pump inhibitor reports compared with 0.7% of histamine-2 receptor antagonist reports. Electrolyte abnormalities also occurred more frequently among those using proton-pump inhibitors.

The authors conclude that the risks and benefits of proton-pump inhibitors should be considered for each patient, and that these medications should be used for the shortest duration possible.

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