Zelnorm Side Effects

Generic name: tegaserod

Note: This document contains side effect information about tegaserod. Some of the dosage forms listed on this page may not apply to the brand name Zelnorm.

Some side effects of Zelnorm may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tegaserod: oral tablet

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.

Stop taking tegaserod (the active ingredient contained in Zelnorm) and call your doctor at once if you have a serious side effect such as:

• new or worsening stomach pain;

• blood in your stools;

• ongoing diarrhea;

• severe stomach pain or cramps; or

• feeling like you might pass out.

Less serious side effects of tegaserod may include:

• headache, dizziness or migraine;

• back pain or joint pain; or

• mild stomach pain, nausea or gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to tegaserod: oral tablet

Cardiovascular

Cardiovascular side effects have included hypotension, angina pectoris, syncope, arrhythmia, bundle branch block, supraventricular tachycardia, and flushing. A case of myocardial infarction has been reported.

Myocardial infarction has been reported in a 64-year-old male after receiving two doses of tegaserod 6 mg.

Nervous system

Nervous system side effects have included headache, dizziness, migraine, insomnia, vertigo, and Raynaud's phenomenon.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, diarrhea, nausea, flatulence, abdominal distention and pain, vomiting, dyspepsia, gastritis, gastroesophageal reflux, hemorrhoids, and proctalgia. Irritable colon, fecal incontinence, tenesmus, increased appetite, eructation, appendicitis, bilirubinemia, subileus, sphincter of Oddi spasm, bile duct stone, ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, and increases in abdominal surgeries, primarily cholecystectomies, have also been reported; however, causality was not clearly established.

Hepatic

Hepatic side effects have included increased SGOT and SGPT. Hepatitis, elevation in ALT, AST, and bilirubin have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included increase in appetite, hypokalemia and hypovolemia secondary to diarrhea, and increased creatine phosphokinase.

Musculoskeletal

Musculoskeletal side effects have included back pain, arthropathy, and myalgia. Other effects, regardless of causality, have included cramps.

Oncologic

Oncologic side effects have included breast carcinoma.

Psychiatric

Psychiatric side effects have included attempted suicide, impaired concentration, emotional lability, increased appetite, sleep disorder and depression.

Respiratory

Respiratory side effects have included asthma.

Dermatologic

Dermatologic side effects have included pruritus. Alopecia has been reported during postmarketing experience.

Endocrine

Endocrine side effects have included increased sweating.

Genitourinary

Genitourinary side effects have included frequent micturition, polyuria, urinary tract infection, ovarian cyst, miscarriage, dysmenorrhea, and menorrhagia.

Renal

Renal side effects have included renal pain and albuminuria.

General

Side effects affecting the body as a whole have included accidental trauma (3% vs. 2% for placebo) and leg pain (1% vs. less than 1% for placebo). Other effects, regardless of causality, have included pain and facial edema.

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