Alosetron

Warning

Alosetron has rarely caused serious, sometimes fatal side effects of the intestines. These effects include reduced blood flow to the large intestine (ischemic colitis) and serious complications of constipation. If you have constipation, new or worsening stomach/abdominal pain, or bloody diarrhea/stools, stop taking this medication and get medical help right away. If your constipation does not go away after stopping alosetron, again tell your doctor right away. Do not take this medication again unless your doctors tells you to do so.

This medication should only be used by women with severe irritable bowel syndrome (IBS) whose main problem is diarrhea. Only carefully selected patients may use this medication. Consult your doctor or pharmacist for more information about the risks and benefits of using alosetron.

Precautions

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: constipation, other bowel/intestinal disorders (such as bowel blockage, ischemic colitis, Crohn's disease, ulcerative colitis, diverticulitis), liver disease, blood clots.

Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially constipation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Remember that this medication has been prescribed because your doctor 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.

Stop taking this medication and get medical help right away if any of these very serious side effects occur: constipation, bloody diarrhea/stools, new or worsening stomach/abdominal 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 very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe 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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