MoviPrep Side Effects

Please note - some side effects for MoviPrep may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of MoviPrep - for the Consumer

MoviPrep

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using MoviPrep:

Bloating; increased thirst or hunger; nausea; rectal irritation; stomach cramps or pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using MoviPrep:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; persistent or severe nausea and vomiting; severe or persistent stomach bloating, swelling, or pain; shivering; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures); symptoms of dehydration (eg, decreased urination; dizziness; dry mouth or eyes; headache; sluggishness; weakness); trouble sleeping; vomiting of blood.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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MoviPrep Side Effects - for the Professional

MoviPrep

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 Reactions* (≥ 2%) in the Study of MoviPrep vs. 4 Liter Polyethylene Glycol plus Electrolytes Solution

*  Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug.  †  4L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution
	MoviPrep® (split dose) N=180	4L PEG + E†   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)

Table 2: The Most Common Drug-Related Adverse Reactions* (≥ 5%) in the Study of MoviPrep vs. 90 mL Oral Sodium Phosphate Solution

*  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 dizziness.  †  OSPS is Oral Sodium Phosphate Solution
	MoviPrep® (evening-only) (full dose) N=169	90 mL OSPS†   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)

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-Weis 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. 

General: Hypersensitivity reactions including anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritis, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness. Fever, chills and dehydration.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Mallory-Weiss tears are quite rare. In one study it occurred in only 0.06% of over 3,000 patients.

Complete rectal prolapse was reported in a 71-year-old who had been given 4 L of PEG-ELS. The patient was observed for 2 days and had no recurrence of the prolapse.

Gastrointestinal side effects have included nausea, vomiting, gas, bloating, complaints of bad taste, anal irritation, and abdominal discomfort. A small percentage of patients who received PEG-ELS have reportedly experienced Mallory-Weiss tears of the esophagus and esophageal perforation. In addition, at least one case of rectal prolapse has been reported.

Cardiovascular

Cardiac arrhythmias, especially increased ventricular ectopy, have been associated with PEG-ELS use.

Cardiovascular side effects have included arrhythmias.

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylaxis. Rash, urticaria, lip and facial swelling, dyspnea, chest tightness, and throat tightness have been reported during postmarketing experience.

A 70-year-old male developed shortness of breath, wheezing, skin flushing, and lowered blood pressure after drinking a second glass of PEG-ELS.

Dermatologic

Dermatologic side effects have rarely included urticaria.

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