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Details with Side Effects
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.
In the MoviPrep trials, abdominal distension, anal discomfort, thirst, nausea, and abdominal pain were some of the most common adverse reactions to MoviPrep administration. Since diarrhea was considered as a part of the efficacy of MoviPrep, diarrhea was not defined as an adverse reaction in the clinical studies. Tables 1 and 2 display the most common drug-related adverse reactions of MoviPrep and its comparator in the controlled MoviPrep trials.
Table 1: The Most Common Drug-Related Adverse
Reactions1 ( ≥ 2%) in the Study of MoviPrep vs. 4 Liter Polyethylene
Glycol plus Electrolytes Solution
|MoviPrep® (split dose)
n (% = n/N)
|4L PEG + E2
n (% = n/N)
|Malaise||35 (19.4)||32 (17.9)|
|Nausea||26 (14.4)||36 (20.1)|
|Abdominal pain||24 (13.3)||27 (15.1)|
|Vomiting||14 (7.8)||23 (12.8)|
|Upper abdominal pain||10 (5.6)||11 (6.1)|
|Dyspepsia||5 (2.8)||2 (1.1)|
|1 Drug-related adverse reactions were adverse events
that were possibly, probably, or definitely related to the study drug.
2 4L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution
Table 2: The Most Common Drug-Related Adverse
Reactions1 ( ≥ 5%) in the Study of MoviPrep vs. 90 mL Oral Sodium
|MoviPrep® (evening-only) (full dose)
n (% = n/N)
|90 mL OSPS2
n (% = n/N)
|Abdominal distension||101 (59.8)||70 (40.9)|
|Anal discomfort||87 (51.5)||89 (52.0)|
|Thirst||80 (47.3)||112 (65.5)|
|Nausea||80 (47.3)||80 (46.8)|
|Abdominal pain||66 (39.1)||55 (32.2)|
|Sleep disorder||59 (34.9)||49 (28.7)|
|Rigors||57 (33.7)||51 (29.8)|
|Hunger||51 (30.2)||121 (70.8)|
|Malaise||45 (26.6)||90 (52.6)|
|Vomiting||12 (7.1)||14 (8.2)|
|Dizziness||11 (6.5)||31 (18.1)|
|Headache||3 (1.8)||9 (5.3)|
|Hypokalemia||0 (0)||10 (5.8)|
|Hyperphosphatemia||0 (0)||10 (5.8)|
|1 Drug-related adverse reactions were adverse
events that were possibly, probably, or definitely related to the study drug.
In addition to the recording of spontaneous adverse events, patients were also
specifically asked about the occurrence of the following symptoms: shivering,
anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting,
weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and
2 OSPS is Oral Sodium Phosphate Solution
Published literature contains isolated reports of serious adverse events following the administration of PEG-based products in patients over 60 years of age. These adverse events included upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after aspirating PEG-based preparation.
In addition to adverse reactions reported from clinical trials, the following adverse events have been identified during post-approval use of MoviPrep. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to MoviPrep, or a combination of these factors.
General: Hypersensitivity reactions including anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness. Fever, chills and dehydration.
Renal: Renal impairment and/or failure.
Read the MoviPrep (peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid) 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 MoviPrep 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]
Potential for Altered Drug Absorption
Oral medication administered within 1 hour of the start of administration of MoviPrep may be flushed from the gastrointestinal tract and the medication may not be absorbed.
Last reviewed on RxList: 10/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional MoviPrep Information
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