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ZELMAC

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Zelmac Adverse Events Reported to the FDA Over Time

How are Zelmac adverse event reports trending over time?

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

Most Common Zelmac Adverse Events Reported to the FDA

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

Diarrhoea
183 (4.7%)
Abdominal Pain
145 (3.73%)
Dizziness
78 (2%)
Constipation
73 (1.88%)
Surgery
72 (1.85%)
Headache
68 (1.75%)
Vomiting
52 (1.34%)
Malaise
51 (1.31%)
Abdominal Distension
50 (1.28%)
Abdominal Pain Upper
46 (1.18%)
Dyspnoea
41 (1.05%)
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Flatulence
41 (1.05%)
Gastritis
35 (.9%)
Hypotension
32 (.82%)
Death
31 (.8%)
Intestinal Obstruction
31 (.8%)
Blood Pressure Increased
30 (.77%)
Drug Ineffective
30 (.77%)
Asthenia
29 (.75%)
Drug Exposure During Pregnancy
29 (.75%)
Pain
29 (.75%)
Diverticulitis
28 (.72%)
Feeling Abnormal
27 (.69%)
Hypertension
26 (.67%)
Tachycardia
26 (.67%)
Back Pain
25 (.64%)
Haematochezia
25 (.64%)
Colitis
24 (.62%)
Nausea
23 (.59%)
Hysterectomy
22 (.57%)
Dehydration
21 (.54%)
Chest Pain
20 (.51%)
Tremor
20 (.51%)
Weight Decreased
20 (.51%)
Gallbladder Operation
19 (.49%)
Heart Rate Increased
19 (.49%)
Depression
18 (.46%)
Haemorrhoids
18 (.46%)
Paraesthesia
18 (.46%)
Rectal Haemorrhage
18 (.46%)
Cerebrovascular Accident
17 (.44%)
Fall
17 (.44%)
Somnolence
17 (.44%)
Vision Blurred
17 (.44%)
Caesarean Section
16 (.41%)
Hemiplegia
16 (.41%)
Hyperhidrosis
16 (.41%)
Mutism
16 (.41%)
Arrhythmia
15 (.39%)
Depressed Level Of Consciousness
15 (.39%)
Palpitations
15 (.39%)
Pyrexia
15 (.39%)
Brain Oedema
14 (.36%)
Computerised Tomogram Abnormal
14 (.36%)
Diverticulum Intestinal
14 (.36%)
Dry Mouth
14 (.36%)
Dyspepsia
14 (.36%)
Fatigue
14 (.36%)
Intracranial Pressure Increased
14 (.36%)
Ischaemic Stroke
14 (.36%)
Nuclear Magnetic Resonance Imaging ...
14 (.36%)
Paralysis Flaccid
14 (.36%)
Blood Pressure Decreased
13 (.33%)
Cardio-respiratory Arrest
13 (.33%)
Increased Appetite
13 (.33%)
Syncope
13 (.33%)
Anxiety
12 (.31%)
Completed Suicide
12 (.31%)
Onychophagia
12 (.31%)
Diverticulum
11 (.28%)
Erythema
11 (.28%)
Haemorrhoid Operation
11 (.28%)
Liver Disorder
11 (.28%)
Nervousness
11 (.28%)
Pallor
11 (.28%)
Pneumonia
11 (.28%)
Aphasia
10 (.26%)
Chills
10 (.26%)
Cholecystectomy
10 (.26%)
Cholelithiasis
10 (.26%)
Colon Cancer
10 (.26%)
Colonoscopy
10 (.26%)
Decreased Appetite
10 (.26%)
Gastrointestinal Disorder
10 (.26%)
Gastrointestinal Motility Disorder
10 (.26%)
Hepatic Steatosis
10 (.26%)
Hyperglycaemia
10 (.26%)
Hypersensitivity
10 (.26%)
Intestinal Haemorrhage
10 (.26%)
Oedema Peripheral
10 (.26%)
Swelling
10 (.26%)
Blood Glucose Increased
9 (.23%)
Diabetes Mellitus
9 (.23%)
Diarrhoea Haemorrhagic
9 (.23%)
Drug Effect Decreased
9 (.23%)
Thrombosis
9 (.23%)
Appendicitis
8 (.21%)
Bone Pain
8 (.21%)
Cardiac Disorder
8 (.21%)
Cardiac Massage
8 (.21%)
Cardioversion
8 (.21%)

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This graph shows the top adverse events submitted to the FDA for Zelmac, 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 Zelmac 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 Zelmac

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

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This graph shows the top categories of adverse events submitted to the FDA for Zelmac, 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 Zelmac 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 Zelmac According to Those Reporting Adverse Events

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

Irritable Bowel Syndrome
448
Constipation
137
Gastrointestinal Disorder
24
Abdominal Pain
12
Colitis
12
Pain
7
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Diverticulitis
7
Gastrointestinal Motility Disorder
6
Dyspepsia
5
Hernia
4
Gastric Disorder
3
Diarrhoea
3
Abdominal Pain Upper
3
Intestinal Obstruction
3
Mucosal Inflammation
2
Congenital Megacolon
2
Gastritis
2
Abdominal Distension
2
Intestinal Hypomotility
2
Gallbladder Pain
1
Flatulence
1
Gastrointestinal Pain
1
Gastrointestinal Inflammation
1
Diverticulum
1
Reflux Gastritis
1
Gallbladder Disorder
1
Presbyoesophagus
1
Intestinal Functional Disorder
1
Abnormal Faeces
1
Hiatus Hernia
1
Gastrooesophageal Reflux Disease
1
Abdominal Discomfort
1
Gastrointestinal Disorder Therapy
1
Ileus
1

Zelmac Case Reports

What Zelmac 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 Zelmac. 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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