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Protonix

[pantoprazole sodium]

UROGENITAL SYSTEM

albuminuria, balanitis, breast pain, cystitis, dysmenorrhea, dysuria, epididymitis, hematuria, impotence, kidney calculus, kidney pain, nocturia, prostatic disorder, pyelonephritis, scrotal edema, urethral pain, urethritis, urinary tract disorder, urination impaired, vaginitis.
In an open-label US clinical trial conducted in 35 patients with pathological hypersecretory conditions treated with PROTONIX for up to 27 months, the adverse events reported were consistent with the safety profile of the drug in other populations.

Postmarketing Reports

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There have been spontaneous reports of adverse events with the postmarketing use of pantoprazole. These reports include anaphylaxis (including anaphylactic shock); angioedema (Quincke's edema); anterior ischemic optic neuropathy; elevated CPK (creatine phosphokinase); severe dermatologic reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal); hepatocellular damage leading to jaundice and hepatic failure; interstitial nephritis; pancreatitis; pancytopenia; and rhabdomyolysis. In addition, also observed have been confusion, hypokinesia, speech disorder, increased salivation, vertigo, nausea, tinnitus, and blurred vision.

Laboratory Values

In two U. S. controlled, short-term trials in patients with erosive esophagitis associated with GERD, 0.4 % of the patients on PROTONIX 40 mg experienced SGPT elevations of greater than three times the upper limit of normal at the final treatment visit. In two U. S. controlled, long-term trials in patients with erosive esophagitis associated with GERD, none of 178 patients (0%) on PROTONIX 40 mg and two of 181 patients (1.1%) on PROTONIX 20 mg, experienced significant transaminase elevations at 12 months (or earlier if a patient discontinued prematurely).

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