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MoviPrep

Last reviewed on RxList: 6/21/2017
MoviPrep Side Effects Center

Last reviewed on RxList 6/21/2017

MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) is a bowel cleanser indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Common side effects of MoviPrep include stomach cramps, general feeling of being unwell (malaise), nausea, abdominal pain, vomiting, indigestion, bloating, gas, anal discomfort, rectal pain or irritation, thirst, sleep problems, shivering, hunger, dizziness, or headache.

The MoviPrep dose for colon cleansing for adult patients is 2 liters (approximately 64 ounces) of MoviPrep solution (with 1 additional liter of clear fluids) taken orally prior to the colonoscopy, as directed. MoviPrep may interact with oral medication administered within 1 hour of the start of administration of MoviPrep, as the medication may be flushed from the gastrointestinal tract and may not be absorbed. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using MoviPrep. It is unknown if MoviPrep could affect a fetus. Consult your doctor before breastfeeding.

Our MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

MoviPrep Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or bloating;
  • no bowel movement within 2 hours after use; or
  • gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

  • mild stomach cramps, gas, or bloating;
  • rectal pain or irritation;
  • nausea; or
  • passing gas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid )

MoviPrep Professional Information

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=180
4L PEG + E2
N=179
n (% = n/N) 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)
1Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug.
24L 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 Phosphate Solutio

  MoviPrep (evening-only) (full dose)
N=169
90 mL OSPS2
N=171
n (% = n/N) 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)
1Drug-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 dizziness.
2OSPS is Oral Sodium Phosphate Solution

Isolated cases of urticaria, rhinorrhea, dermatitis, and anaphylactic reaction have been reported with PEG-based products and may represent allergic reactions.

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.

Postmarketing Experience

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.

Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema.

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.

Nervous system:Syncope, tremor, seizure.

Renal:Renal impairment and/or failure.

Read the entire FDA prescribing information for MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid )

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© MoviPrep Patient Information is supplied by Cerner Multum, Inc. and MoviPrep Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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