Zelnorm

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Zelnorm

Zelnorm Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zelnorm (tegaserod maleate) is a serotonin agonist used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation (and not diarrhea) as their main bowel problem. It is also used to treat chronic constipation in patients younger than 55 years old. The brand name of this medication is no longer available in the U.S., but may be used in limited emergency situations. Common side effects include headache, dizziness, migraine, back pain, joint pain, stomach pain, nausea, or gas.

The recommended dosage of Zelnorm is 6 mg taken twice daily orally before meals for 4 to 6 weeks. Zelnorm may interact with other drugs. Tell your doctor all medications and supplements you use. Zelnorm is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Zelnorm (tegaserod maleate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zelnorm in Detail - Patient Information: Side Effects

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 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 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.

Read the entire detailed patient monograph for Zelnorm (Tegaserod Maleate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zelnorm FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

IBS with Constipation

In Phase 3 clinical trials 2,632 female and male patients received Zelnorm® (tegaserod maleate) 6 mg b.i.d. or placebo. The frequency and type of adverse events for females and males were similar. The following adverse experiences were reported in 1% or more of patients who received Zelnorm (tegaserod maleate) and occurred more frequently on Zelnorm (tegaserod maleate) than placebo:

Adverse Events Occurring in 1% of IBS Patients and More Frequently on Zelnorm® (tegaserod maleate) than Placebo
System/ Adverse Experience Zelnorm® 6 mg b.i.d. (n=1,327) Placebo (n=1,305)
Gastrointestinal System Disorders
Abdominal Pain 12% 11%
Diarrhea 9% 4%
Nausea 8% 7%
Flatulence 6% 5%
Central and Peripheral Nervous System
Headache 15% 12%
Dizziness 4% 3%
Migraine 2% 1%
Body as a Whole - General Disorders
Accidental Trauma 3% 2%
Leg Pain 1% < 1%

Musculoskeletal System Disorders

Back Pain 5% 4%
     
Arthropathy 2% 1%

Chronic Idiopathic Constipation

In phase 3 clinical trials 2,603 male and female patients received Zelnorm (tegaserod maleate) 6 mg b.i.d., 2 mg b.i.d. or placebo. The following adverse experiences were reported in 1% or more of patients who received Zelnorm (tegaserod maleate) and occurred more frequently than in patients who received placebo.

Adverse Events Occurring in 1% of Chronic Idiopathic Constipation Patients And More Frequently On Either Dose of Zelnorm® Than Placebo
System/ Adverse Experience Zelnorm® 6 mg b.i.d. (n=881)

Zelnorm® 2 mg b.i.d. (n=861)

Placebo (n=861)

Gastrointestinal System Disorders

Diarrhea

7% 4% 3%
Abdominal pain 5% 6% 5%
Nausea 5% 5% 4%
Abdominal distension 4% 3% 4%
Abdominal pain upper 2% 2% 2%
Vomiting 2% 1% 1%
Central and Peripheral Nervous System
Dizziness 2% 1% 2%
Insomnia 2% 1% 1%
Headache aggravated 1% 1% 0%
General disorders and administration site conditions
Fatigue 1% 1% 1%
Infections and infestations
Upper respiratory tract infection 4% 3% 2%
Sinusitis 3% 3% 2%
Fungal infection 0% 1% 1%
Musculoskeletal and connective tissue disorders

Back Pain

3% 2% 3%

Myalgia

1% 1% 1%
Reproductive system and breast disorders

Dysmenorrhoea

1% 2% 1%

Respiratory, thoracic and mediastinal disorders

Pharyngitis 1% 1% 1%

Sinus congestion

1% 0% 1%

Renal and urinary disorders

Urinary tract infection

1% 2% 1%

Skin and subcutaneous tissue disorders

Rash

1% 1% 0%

Pruritus

0% 1% 0%

Zelnorm (tegaserod maleate) was not associated with changes in ECG intervals.

Zelnorm (tegaserod maleate) -Induced Diarrhea

IBS with Constipation

In the Phase 3 clinical studies, 8.8% of patients receiving Zelnorm (tegaserod maleate) reported diarrhea as an adverse experience compared to 3.8% of patients receiving placebo. The majority of the Zelnorm (tegaserod maleate) patients reporting diarrhea had a single episode. In most cases, diarrhea occurred within the first week of treatment. Typically, diarrhea resolved with continued therapy. Overall, the discontinuation rate from the studies due to diarrhea was 1.6% among the Zelnorm (tegaserod maleate) -treated patients. In clinical studies, a small number of patients (0.04%) experienced clinically significant diarrhea including hospitalization, hypovolemia, hypotension and need for intravenous fluids. Diarrhea can be the pharmacologic response to Zelnorm (tegaserod maleate) .

Chronic Idiopathic Constipation

In the two Phase 3 studies, 6.6% of patients treated with Zelnorm (tegaserod maleate) 6 mg b.i.d. and 4.2% of patients treated with Zelnorm (tegaserod maleate) 2 mg b.i.d. reported diarrhea as an adverse event, versus 3.0% of patients receiving placebo.

The diarrhea episodes experienced by patients treated with tegaserod occurred early after initiation of treatment (median of 5.5 days), were of short duration (median of 2.5 days), and occurred only once in the majority of patients.

Typically, diarrhea resolved with continued therapy; only 0.9% of patients treated with Zelnorm (tegaserod maleate) 6 mg b.i.d. discontinued the study due to diarrhea (compared to 0.3% in the Zelnorm (tegaserod maleate) 2 mg b.i.d. group and 0.2% in the placebo group).

Abdominal Surgeries, Including Cholecystectomy

An increase in abdominal surgeries was observed on Zelnorm (tegaserod maleate) (9/2,965; 0.3%) vs. placebo (3/1,740; 0.2%) in the Phase 3 IBS clinical studies. The increase was primarily due to a numerical imbalance in cholecystectomies reported in patients treated with Zelnorm (tegaserod maleate) (5/2,965; 0.17%) vs. placebo (1/1,740; 0.06%). In chronic idiopathic constipation clinical trials there was no increase in the frequency of abdominal and pelvic surgeries in active versus placebo groups: 9/1752; 0.5% on Zelnorm (tegaserod maleate) versus 8/861; 0.9% on placebo. A causal relationship between abdominal surgeries and Zelnorm (tegaserod maleate) has not been established.

Other adverse events

The following list of adverse events includes those from phase 3 clinical studies (6 mg b.i.d. or 2 mg b.i.d.) which were reported more frequently (>0.2%) in patients on Zelnorm (tegaserod maleate) than placebo; or which were considered by the investigator to be possibly related to Zelnorm (tegaserod maleate) and reported more frequently (>0.1%) on Zelnorm (tegaserod maleate) than placebo; or which lead to discontinuation more frequently ( 0.1% and in more than 1 patient) on Zelnorm (tegaserod maleate) than placebo. The list also contains those serious adverse events from all clinical trials in patients treated with either 6 mg b.i.d. or 2 mg b.i.d. Zelnorm (tegaserod maleate) which were either considered by the investigator as possibly drug related, or occurred in at least 2 more patients on Zelnorm (tegaserod maleate) than on placebo. Although the events reported occurred during treatment with Zelnorm (tegaserod maleate) , they were not necessarily caused by it.

Cardiac disorders : Angina pectoris, supraventricular tachycardia, syncope

Ear and labyrinth disorders : Vertigo

Eye disorders : Visual disturbance

Gastrointestinal disorders : Hemorrhoids, proctalgia, stomach discomfort, fecal incontinence, irritable bowel syndrome, dyspepsia, gastroesophageal reflux, gastritis

General disorders and administration site conditions : Chest pain, peripheral edema

Hepatobiliary disorders : Cholelithiasis

Immune system disorders : Hypersensitivity reactions

Investigations : Creatinine phosphokinase increased, increased eosinophil count, low neutrophil count

Metabolism and nutrition disorders : increased appetite

Neoplasms benign, malignant and unspecified (including cysts and polyps) : Breast carcinoma

Psychiatric disorders : Depression, sleep disorder, restlessness

Respiratory, thoracic and mediastinal disorders : Dyspnea, pharyngolaryngeal pain

Reproductive system and breast disorders : Miscarriage, menorrhagia

Surgical and medical procedures : Cholecystectomy

Vascular disorders : Flushing, hypotension

Post Marketing Experience

Voluntary reports of adverse events occurring with the use of Zelnorm (tegaserod maleate) include the following: ischemic colitis (see PRECAUTIONS), mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, hypotension, hypovolemia, electrolyte disorders, suspected sphincter of Oddi spasm, bile duct stone, cholecystitis with elevated transaminases, and hypersensitivity reaction including rash, urticaria, pruritus and serious allergic Type I reactions. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm (tegaserod maleate) use has been established.

Post-marketing reports of diarrhea, which can be a pharmacologic response to Zelnorm (tegaserod maleate) , have also been received.

Read the entire FDA prescribing information for Zelnorm (Tegaserod Maleate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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