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Tegaserod Side Effects

For the Consumer

Applies to tegaserod: oral tablets

Side effects include:

IBS patients: headache, migraine, dizziness, abdominal pain, diarrhea, nausea, flatulence, back pain, leg pain, accidental trauma, arthropathy.

Patients with chronic idiopathic constipation: diarrhea, abdominal pain, nausea, abdominal distension, upper abdominal pain, vomiting, dizziness, insomnia, aggravated headache, fatigue, upper respiratory tract infection, sinusitis, fungal infection, back pain, myalgia, dysmenorrhea, pharyngitis, sinus congestion, urinary tract infection, rash, pruritus.

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.[Ref]

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

Nervous system

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

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.[Ref]

Hepatic

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

Metabolic

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

Musculoskeletal

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

Oncologic

Oncologic side effects have included breast carcinoma.[Ref]

Psychiatric

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

Respiratory

Respiratory side effects have included asthma.[Ref]

Dermatologic

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

Endocrine

Endocrine side effects have included increased sweating.[Ref]

Genitourinary

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

Renal

Renal side effects have included renal pain and albuminuria.[Ref]

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.[Ref]

References

1. Morganroth J, Ruegg PC, Dunger-Baldauf C, Appel-Dingemanse S, Bliesath H, Lefkowitz M "Tegaserod, a 5-hydroxytryptamine type 4 receptor partial agonist, is devoid of electrocardiographic effects." Am J Gastroenterol 97 (2002): 2321-7

2. "Product Information. Zelnorm (tegaserod)." Novartis Pharmaceuticals, East Hanover, NJ.

3. Busti AJ, Murillo JR Jr, Cryer B "Tegaserod-induced myocardial infarction: case report and hypothesis." Pharmacotherapy 24 (2004): 526-31

4. Bertoli R, Girardin F, Russmann S, Lauterburg BH "Raynaud's phenomenon induced by drugs acting on neurotransmission: two cases under reboxetine and one under tegaserod." Eur J Clin Pharmacol 58 (2003): 717

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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