Tegaserod (teg-a-SER-od)

Treats symptoms of irritable bowel syndrome (IBS) in women whose main problem is constipation. Also treats certain types of long-term constipation. This medicine was withdrawn from the US market on March 30, 2007, but is still available on a very limited basis for restricted use. Women who would like to be considered for this program should contact their doctor for an evaluation.

Brand Name(s):

Zelnorm

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach, at least 30 minutes before meals.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, heart disease, diabetes, high blood pressure, high cholesterol, obesity, depression, or if you smoke. Tell your doctor if you have diarrhea right now or if you have diarrhea often.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Increased risk of heart attack or stroke
  • Ischemic colitis (swelling and injury of the bowels caused by not enough blood flow to the bowels)
  • Changes in mood or behavior, including thoughts of suicide
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, that may spread to your arms, jaw, back, or neck, trouble breathing, coughing up blood, nausea, unusual sweating
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Rectal bleeding, severe or bloody diarrhea, new or worsening stomach pain, severe stomach cramping
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual mood or behavior, thoughts or attempts of killing oneself

If you notice these less serious side effects, talk with your doctor:

• Bloated or full feeling, passing gas

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088