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OsmoPrep Side Effects

Please note - some side effects for OsmoPrep 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 OsmoPrep - for the Consumer

OsmoPrep

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 OsmoPrep:

Diarrhea; gas; nausea; stomach cramps or bloating; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the stool; confusion; fainting; fast, slow or irregular heartbeat; loss of appetite; loss of consciousness; seizures; severe or persistent nausea, stomach bloating, or cramping; symptoms of dehydration (eg, dizziness, headache, severe or persistent vomiting, unusually dry mouth or eyes); symptoms of kidney problems (eg, decreased urination; swelling of the ankles, feet, or legs); tingling of the lips; unusual weakness; unusual weight gain; wheezing.

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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OsmoPrep Side Effects - for the Professional

OsmoPrep

Abdominal bloating, abdominal pain, nausea, 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 2 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 2: Frequency of Adverse Events of Any Severity
Occurring in Greater Than 3% of Patients in the OsmoPrep
Trials
  OsmoPrep
32 tabs (48 g)
N=272
OsmoPrep
40 tabs (60 g)
N=265
Visicol
40 tabs (60 g)
N=268
Bloating 31% 39% 41%
Nausea 26% 37% 30%
Abdominal Pain 23% 24% 25%
Vomiting 4% 10% 9%

Postmarketing Experience

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.

General: 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.

Cardiovascular: Arrhythmias

Nervous system: Seizures

Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects of the tablet form of sodium biphosphate and sodium phosphate have included bloating (31% to 41%), nausea (26% to 30%), abdominal pain (23% to 25%), and vomiting (4% to 9%). The enema form has caused anal irritation, diarrhea, nausea, and stomach cramps.

Nervous system

Nervous system side effects have included dizziness, headache, and seizures.

Renal

Renal side effects have included renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

Hypersensitivity

Hypersensitivity reactions reported postmarketing have included anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphasia, paresthesia, swelling of the lips and tongue, and facial swelling.

Respiratory

Respiratory side effects occurring during post-marketing experience have included bronchospasm, dyspnea, and dysphagia.

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