Entereg Side Effects
Generic Name: alvimopan
Please note - some side effects for Entereg 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 Entereg - for the Consumer
Entereg
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 Entereg:
Seek medical attention right away if any of these SEVERE side effects occur when using Entereg:Constipation; gas; indigestion.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain, numbness of an arm or leg, fainting, or sudden, severe headache or vomiting; fast, slow, or irregular heartbeat; muscle cramps, pain, or weakness; severe or persistent diarrhea, stomach pain, or stomach cramps; trouble urinating or inability to urinate; unusual tiredness or weakness.
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.
TopEntereg Side Effects - for the Professional
Entereg
Clinical Trials 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. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described below reflect exposure to Entereg in 1,650 patients in 9 placebo-controlled studies worldwide. The population was 19 to 97 years old, 68% were female, and 83% were Caucasian; 61% were undergoing bowel resection surgery. The first dose of Entereg was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).
Table 1 presents treatment-emergent adverse reactions reported in ≥3% patients treated with Entereg and for which the rate for Entereg was ≥1% than placebo. Treatment-emergent adverse reactions are those events occurring after the first dose of study medication treatment and within 7 days of the last dose of study medication or those events present at baseline that increased in severity after the start of study medication treatment.
| System Organ Class | Bowel Resection Patients | All Surgical Patients | |||
|---|---|---|---|---|---|
| Placebo (n = 986) % |
Entereg (n=999) % |
Placebo (n = 1,365) % |
Entereg (n = 1,650) % |
||
| Blood and lymphatic system disorders | |||||
| Anemia | 4.2 | 5.2 | 5.4 | 5.4 | |
| Gastrointestinal disorders | |||||
| Constipation | 3.9 | 4.0 | 7.6 | 9.7 | |
| Dyspepsia | 4.6 | 7.0 | 4.8 | 5.9 | |
| Flatulence | 4.5 | 3.1 | 7.7 | 8.7 | |
| Metabolism and nutrition disorders | |||||
| Hypokalemia | 8.5 | 9.5 | 7.5 | 6.9 | |
| Musculoskeletal and connective tissue disorders | |||||
| Back Pain | 1.7 | 3.3 | 2.6 | 3.4 | |
| Renal and urinary disorders | |||||
| Urinary retention | 2.1 | 3.2 | 2.3 | 3.5 | |
Side Effects by Body System - for Healthcare Professionals
Hematologic
Hematologic side effects including anemia (5.2% to 5.4%).
Genitourinary
Genitourinary side effects have included urinary retention (3.2% to 3.5%).
Gastrointestinal
Gastrointestinal side effects have included constipation (4% to 9.7%), flatulence (3.1% to 8.7%), and dyspepsia (5.9% to 7%).
Metabolic
Metabolic side effects have included hypokalemia (6.9% to 9.5%).
Musculoskeletal
Musculoskeletal side effects have included back pain (3.3% to 3.4%).
TopMore Entereg resources
- Entereg Prescribing Information (FDA)
- Entereg Monograph (AHFS DI)
- Entereg Advanced Consumer (Micromedex) - Includes Dosage Information
- Entereg Consumer Overview
- Entereg MedFacts Consumer Leaflet (Wolters Kluwer)
- Alvimopan Professional Patient Advice (Wolters Kluwer)
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