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adverse reactions
ADVERSE REACTIONS 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 and occurred more frequently on Zelnorm 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 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 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 D isorders and A dministration S ite C onditions Fatigue 1% 1% 1% Infections and I nfestations Upper Respiratory Tract Infection 4% 3% 2% Sinusitis 3% 3% 2% Fungal Infection 0% 1% 1% Musculoskeletal and C onnective T issue D isorders Back Pain 3% 2% 3% Myalgia 1% 1% 1% Reproductive S ystem and B reast D isorders Dysmenorrhea 1% 2% 1% Respiratory, T horacic and M ediastinal disorders Pharyngitis 1% 1% 1% Sinus Congestion 1% 0% 1% Renal and U rinary D isorders Urinary Tract Infection 1% 2% 1% Skin and S ubcutaneous T issue D isorders Rash 1% 1% 0% Pruritus 0% 1% 0% Zelnorm was not associated with changes in ECG intervals. Zelnorm-Induced Diarrhea IBS with Constipation In the Phase 3 clinical studies, 8.8% of patients receiving Zelnorm reported diarrhea as an adverse experience compared to 3.8% of patients receiving placebo. The majority of the Zelnorm 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-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. Chronic Idiopathic Constipation In the two Phase 3 studies, 6.6% of patients treated with Zelnorm 6 mg b.i.d. and 4.2% of patients treated with Zelnorm 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 6 mg b.i.d. discontinued the study due to diarrhea (compared to 0.3% in the Zelnorm 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 (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 (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 vs. placebo groups: 9/1,752; 0.5% on Zelnorm versus 8/861; 0.9% on placebo. A causal relationship between abdominal surgeries and Zelnorm has not been established. Other A dverse E vents 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 than placebo; or which were considered by the investigator to be possibly related to Zelnorm and reported more frequently (>0.1%) on Zelnorm than placebo; or which lead to discontinuation more frequently (≥0.1% and in more than 1 patient) on Zelnorm 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 which were either considered by the investigator as possibly drug related, or occurred in at least 2 more patients on Zelnorm than on placebo. Although the events reported occurred during treatment with Zelnorm, they were not necessarily caused by it. Cardiac D isorders: Angina pectoris, supraventricular tachycardia, syncope Ear and L abyrinth D isorders: Vertigo Eye D isorders: Visual disturbance Gastrointestinal D isorders: Hemorrhoids, proctalgia, stomach discomfort, fecal incontinence, irritable bowel syndrome, dyspepsia, gastroesophageal reflux, gastritis General D isorders and A dministration S ite C onditions: Chest pain, peripheral edema Hepatobiliary D isorders: Cholelithiasis Immune S ystem D isorders : Hypersensitivity reactions Investigations: Creatinine phosphokinase increased, increased eosinophil count, low neutrophil count Metabolism and N utrition D isorders: Increased appetite Neoplasms B enign, M alignant and U nspecified ( incl uding cysts and polyps ): Breast carcinoma Psychiatric D isorders: Depression, sleep disorder, restlessness Respiratory , T horacic and M ediastinal D isorders: Dyspnea, pharyngolaryngeal pain Reproductive S ystem and B reast D isorders: Miscarriage, menorrhagia Surgical and M edical P rocedures: Cholecystectomy Vascular D isorders: Flushing, hypotension Post - Marketing Experience Voluntary reports of adverse events occurring with the use of Zelnorm 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 use has been established. Post-marketing reports of diarrhea, which can be a pharmacologic response to Zelnorm, have also been received.