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Side Effects & Drug Interactions
ADVERSE REACTIONS
Worldwide, more than 11,100 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment. In general, pantoprazole has been well tolerated in both short-term and long-term trials. In two U. S. controlled clinical trials involving PROTONIX 10-, 20-, or 40-mg doses for up to 8 weeks, there were no dose-related effects on the incidence of adverse events. The following adverse events considered by investigators to be possibly, probably or definitely related to drug occurred in 1% or more in the individual studies of GERD patients on therapy with PROTONIX. Text Continues Below
In addition, in these short-and long-term domestic and international trials, the following treatment-emergent events, regardless of causality, occurred at a rate of 1% in pantoprazole-treated patients: anxiety, arthralgia, asthenia, back pain, bronchitis, chest pain, constipation, cough increased, dizziness, dyspepsia, dyspnea, flu syndrome, gastroenteritis, gastrointestinal disorder, hyperlipemia, hypertonia, infection, liver function tests abnormal, migraine, nausea, neck pain, pain, pharyngitis, rectal disorder, rhinitis, SGPT increased, sinusitis, upper respiratory tract infection, urinary frequency, urinary tract infection, and vomiting.
Additional treatment-emergent adverse experiences occurring in <1% of pantoprazole-treated patients from these trials are listed below by body system. In most instances the relationship to pantoprazole was unclear.
BODY AS A WHOLE abscess, allergic reaction, chills, cyst, face edema, fever, generalized edema, heat stroke, hernia, laboratory test abnormal, malaise, moniliasis, neoplasm, non-specified drug reaction, photosensitivity reaction. CARDIOVASCULAR SYSTEM abnormal electrocardiogram, angina pectoris, arrhythmia, atrial fibrillation/ flutter, cardiovascular disorder, chest pain substernal, congestive heart failure, hemorrhage, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitation, retinal vascular disorder, syncope, tachycardia, thrombophlebitis, thrombosis, vasodilatation. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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