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ZELNORM

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Zelnorm Adverse Events Reported to the FDA Over Time

How are Zelnorm adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Zelnorm, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Zelnorm is flagged as the suspect drug causing the adverse event.

Most Common Zelnorm Adverse Events Reported to the FDA

What are the most common Zelnorm adverse events reported to the FDA?

Chest Pain
763 (3.16%)
Diarrhoea
668 (2.76%)
Abdominal Pain
591 (2.44%)
Dizziness
553 (2.29%)
Dyspnoea
547 (2.26%)
Constipation
395 (1.63%)
Nausea
385 (1.59%)
Headache
295 (1.22%)
Asthenia
287 (1.19%)
Myocardial Infarction
278 (1.15%)
Vomiting
277 (1.15%)
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Abdominal Distension
272 (1.13%)
Cardiac Disorder
260 (1.08%)
Palpitations
249 (1.03%)
Drug Ineffective
248 (1.03%)
Cerebrovascular Accident
244 (1.01%)
Hypertension
226 (.93%)
Rectal Haemorrhage
225 (.93%)
Fatigue
212 (.88%)
Heart Rate Increased
203 (.84%)
Injury
199 (.82%)
Pain
193 (.8%)
Colitis Ischaemic
190 (.79%)
Abdominal Pain Upper
186 (.77%)
Haematochezia
180 (.74%)
Condition Aggravated
179 (.74%)
Chest Discomfort
158 (.65%)
Back Pain
153 (.63%)
Hypoaesthesia
147 (.61%)
Loss Of Consciousness
147 (.61%)
Pain In Extremity
132 (.55%)
Oedema Peripheral
129 (.53%)
Anxiety
128 (.53%)
Feeling Abnormal
118 (.49%)
Gait Disturbance
116 (.48%)
Flatulence
113 (.47%)
Depression
110 (.46%)
Transient Ischaemic Attack
109 (.45%)
Weight Decreased
106 (.44%)
Cholecystectomy
104 (.43%)
Angina Pectoris
102 (.42%)
Surgery
98 (.41%)
Weight Increased
98 (.41%)
Dehydration
97 (.4%)
Malaise
96 (.4%)
Catheterisation Cardiac
95 (.39%)
Hyperhidrosis
95 (.39%)
Haemorrhoids
94 (.39%)
Pyrexia
93 (.38%)
Blood Pressure Increased
91 (.38%)
Hypotension
91 (.38%)
Heart Rate Irregular
90 (.37%)
Stent Placement
90 (.37%)
Syncope
90 (.37%)
Gastrooesophageal Reflux Disease
86 (.36%)
Insomnia
85 (.35%)
Fall
83 (.34%)
Diarrhoea Haemorrhagic
81 (.34%)
Dyspepsia
78 (.32%)
Muscle Spasms
76 (.31%)
Anaemia
75 (.31%)
White Blood Cell Count Increased
72 (.3%)
Muscular Weakness
68 (.28%)
Abdominal Pain Lower
67 (.28%)
Atrial Fibrillation
67 (.28%)
Electrocardiogram Abnormal
67 (.28%)
Pruritus
66 (.27%)
Arrhythmia
65 (.27%)
Migraine
64 (.26%)
Coronary Artery Disease
62 (.26%)
Arthralgia
61 (.25%)
Amnesia
60 (.25%)
Paraesthesia
60 (.25%)
Speech Disorder
60 (.25%)
Cholelithiasis
58 (.24%)
Coronary Artery Occlusion
58 (.24%)
Memory Impairment
57 (.24%)
Abdominal Tenderness
55 (.23%)
Faeces Discoloured
55 (.23%)
Colonoscopy Abnormal
54 (.22%)
Convulsion
54 (.22%)
Death
54 (.22%)
Tremor
54 (.22%)
Blood Pressure Decreased
53 (.22%)
Dysarthria
51 (.21%)
Vision Blurred
50 (.21%)
Cardiac Failure Congestive
49 (.2%)
Irritable Bowel Syndrome
49 (.2%)
Pneumonia
49 (.2%)
Cardiac Flutter
48 (.2%)
Colitis
48 (.2%)
Coronary Arterial Stent Insertion
48 (.2%)
Abdominal Discomfort
47 (.19%)
Alopecia
47 (.19%)
Computerised Tomogram Abnormal
46 (.19%)
Drug Interaction
46 (.19%)
Gastrointestinal Disorder
46 (.19%)
Stress
46 (.19%)
Tachycardia
46 (.19%)
Blood Glucose Increased
45 (.19%)
Cardiac Valve Disease
44 (.18%)

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This graph shows the top adverse events submitted to the FDA for Zelnorm, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zelnorm is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Zelnorm

What are the most common Zelnorm adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Zelnorm, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zelnorm is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Zelnorm According to Those Reporting Adverse Events

Why are people taking Zelnorm, according to those reporting adverse events to the FDA?

Irritable Bowel Syndrome
2119
Constipation
995
Impaired Gastric Emptying
96
Gastrointestinal Disorder
52
Drug Use For Unknown Indication
44
Abdominal Distension
41
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Gastric Disorder
39
Abdominal Pain
30
Gastrooesophageal Reflux Disease
30
Gastrointestinal Motility Disorder
26
Diarrhoea
21
Bowel Movement Irregularity
14
Nausea
14
Intestinal Functional Disorder
13
Diverticulitis
12
Product Used For Unknown Indication
11
Abdominal Pain Upper
10
Crohns Disease
10
Dyspepsia
8
Flatulence
8
Gastrointestinal Hypomotility
7
Colitis
7
Reflux Oesophagitis
6
Inflammatory Bowel Disease
5
Ileus
5
Abdominal Discomfort
5
Intestinal Hypomotility
5
Ileus Paralytic
4
Gastric Hypomotility
4
Diabetic Gastroparesis
4
Colitis Ulcerative
4
Faeces Hard
3
Gastroenteritis Viral
3
Congenital Megacolon
3
Gastritis
2
Stomach Discomfort
2
Muscle Disorder
2
Crest Syndrome
2
Nerve Injury
2
Colonoscopy
2
Intestinal Obstruction
2
Pain
2
Prophylaxis
2
Eructation
2
Hypertension
1
Irritability
1
Oesophageal Spasm
1
Diverticulum
1
Colon Cancer
1
Postoperative Ileus
1
Gastroenteritis
1

Zelnorm Case Reports

What Zelnorm safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Zelnorm. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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