Safety Profile
AMITIZA Has a Demonstrated Safety Profile
AMITIZA has a demonstrated safety profile based on safety studies up to 52 weeks. While AMITIZA can be effective for appropriate patients, it is not recommended for everyone.
Important Safety Information to Discuss with Your Healthcare Provider
AMITIZA is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA.
AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus.
Tell your doctor if you experience nausea so you can learn ways to manage it. You should also immediately tell your doctor if you develop diarrhea during treatment with AMITIZA, or if your diarrhea or nausea becomes severe.
Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may also occur. These symptoms usually go away within three hours, but may recur with repeated use. Be sure to tell your healthcare provider if you experience these symptoms.
What Are the Most Common Side Effects?
AMITIZA (8 mcg) twice daily has side effects. For Irritable Bowel Syndrome (IBS-C), the most common are:
- Nausea
- Diarrhea
- Abdominal pain
While these aren't all the side effects of AMITIZA, your healthcare provider or pharmacist can give you a more complete list. Tell your healthcare provider if you have liver problems. Remember, your healthcare provider is your best resource, so always let them know about any side effects you may have.
These are not all of the side effects associated with AMITIZA. See Prescribing Information for complete list.
Finding a Treatment that May Be Right for You
While it can be effective in appropriate patients, AMITIZA is not recommended for everyone. Before taking AMITIZA you should talk to your healthcare provider if you:
- Have a kidney or liver disease
- Are breastfeeding. It is not known if AMITIZA passes into your milk or, if it does, what effects it has on your child
- Cannot swallow a capsule
Indication
AMITIZA (8 mcg) twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.
Important Safety Information
AMITIZA is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.
AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus.
Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food. If your nausea or diarrhea becomes severe, tell your healthcare provider.
Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.
The most common side effects of taking AMITIZA (8 mcg) twice daily, pink capsules for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.
Tell your doctor if you have liver problems.
Please click here for complete Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
