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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using OsmoPrep:Diarrhea; gas; headache; mild dizziness; nausea; stomach cramps or bloating; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); blood in the stool; irregular heartbeat; loss of consciousness; seizures; severe dizziness; tingling of the lips.
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).
| OsmoPrep 32 tabs (48 g) N=272 |
OsmoPrep 40 tabs (60 g) N=265 |
Visicol 40 tabs (60 g) N=268 |
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|---|---|---|---|
| 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, pharyngeal edema, paresthesia and swelling of the lips, and facial swelling.
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