Pantovex Adverse Reactions

Adverse effects occurring in 4% or more of patients receiving IV pantoprazole and that were possibly, probably, or definitely related to treatment include abdominal pain, chest pain, rash, and pruritus. Adverse effects occurring in more than 1% of patients receiving IV pantoprazole and that generally had an unclear relationship to the drug include headache, injection site reaction, dyspepsia, diarrhea, vomiting, dizziness, and rhinitis. There have been spontaneous reports of adverse events; angioedema (Quincke's edema); anterior ischemic optic neuropathy; severe dermatologic reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal); hepatocellular damage leading to jaundice and hepatic failure; pancreatitis; pancytopenia; and rhabdomyolysis. In addition, also observed have been confusion, hypokinesia, speech disorder, increased salivation, vertigo, nausea, tinnitus, and blurred vision.
FDA Pregnancy Risk Category: B/NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility.