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Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Abdominal bloating, nausea, abdominal pain, and vomiting were the most common adverse events reported with the use of OsmoPrep Tablets. Dizziness and headache were reported less frequently. Since diarrhea was considered as a part of the efficacy of OsmoPrep, diarrhea was not defined as an adverse event in the clinical studies. Table 1 shows the most common adverse events associated with the use of 48 grams of OsmoPrep, 60 grams of OsmoPrep, and 60 grams of Visicol in the colon preparation trials (n= 931).
Table 1: Frequency of Adverse Events of Any Severity
Occurring in Greater Than 3% of Patients in the OsmoPrep Trials
|OsmoPrep 32 tabs (48 g)
|OsmoPrep 40 tabs (60 g)
|Visicol 40 tabs (60 g)
In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of OsmoPrep. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to OsmoPrep, or a combination of these factors.
Body as a Whole: Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling.
Nervous system: Seizures
Read the OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Side Effects Center for a complete guide to possible side effects
Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities
Use caution when prescribing OsmoPrep for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see WARNINGS] in patients taking these concomitant medications.
Potential for Altered Drug Absorption
Oral medication administered within one hour of the start of each OsmoPrep dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.
Drug Abuse And Dependence
Laxatives and purgatives (including OsmoPrep) have the potential for abuse by patients who frequently engage in binge eating and vomiting to lose weight.
Read the OsmoPrep Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/25/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional OsmoPrep Information
OsmoPrep - User Reviews
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Report Problems to the Food and Drug Administration
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