Entereg Capsules

Entereg Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Entereg (alvimopan) is used to speed recovery of stomach and intestinal functions after a gastrointestinal surgery and to prevent side effects caused by narcotic medications. It is an opioid receptor antagonist that works by preventing narcotic side effects without reducing the pain-relieving effects of the drug. Common side effects include stomach pain or upset, nausea, vomiting, diarrhea, constipation, gas, or back pain.

The recommended adult dosage of Entereg is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery for a maximum of 7 days or until discharge. It is for hospital use only. Entereg may interact with narcotics. Tell your doctor all medications and supplements you use. Entereg is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Entereg (alvimopan) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Entereg in Detail - Patient Information: Side Effects

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

Tell your caregivers at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • painful or difficult urination;
  • urinating less than usual or not at all;
  • confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • stomach pain, indigestion;
  • nausea, vomiting, diarrhea;
  • constipation, gas; or
  • back pain.

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 Entereg (Alvimopan Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Entereg FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Table 1. Treatment-Emergent Adverse Reactions That Were Reported in ≥ 3% of Either Bowel Resection Patients Treated With ENTEREG or All Surgical Patients Treated With ENTEREG and for Which the Rate for ENTEREG Was ≥ 1% Than Placebo

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

Read the entire FDA prescribing information for Entereg (Alvimopan Capsules) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.