Alosetron has rarely caused serious, sometimes fatal intestinal side effects including constipation and ischemic colitis. You should not use this medication if you have ever had problems from blocked blood flow to the bowel (ischemic colitis).
This medication should only be used in women with severe cases of irritable bowel syndrome (IBS) where the major symptom is diarrhea. If you experience constipation, new or worsening bowel pains, or blood in your diarrhea or stool, stop taking this drug and seek immediate medical attention.
Before your doctor can prescribe this medication for you, your doctor must have completed the Prescribing Program for Lotronex (PPL).
Only carefully selected patients may use this medication. Consult your doctor or pharmacist for more information about the risks and benefits of using this medication.
Before taking alosetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal disorders (e.g., ileus, ischemic colitis, impaired intestinal circulation, constipation or its complications, obstruction, megacolon, stricture/adhesions, or perforation), Crohn's disease, ulcerative colitis, diverticulitis, severe liver disease, blood disorders (e.g., history of blood clots).
Before using this medication, tell your doctor your medical history, including: liver disease.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of constipation if it occurs.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Headache, stomach upset, or hemorrhoids may occur. If these effects persist or worsen, notify your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any of these unlikely but serious side effects: bloating, depression.
Stop taking this medication and seek immediate medical attention if any of these unlikely but serious side effects occur: constipation, bloody stools, unexplained fever, unusually fast pulse, new or sudden worsening of stomach/abdominal/bowel pain.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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Information expires June 2016.