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OMEPRAL

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Omepral Adverse Events Reported to the FDA Over Time

How are Omepral adverse event reports trending over time?

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

Most Common Omepral Adverse Events Reported to the FDA

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

Interstitial Lung Disease
66 (3.21%)
Rhabdomyolysis
48 (2.34%)
Hepatic Function Abnormal
45 (2.19%)
Aspartate Aminotransferase Increase...
38 (1.85%)
Platelet Count Decreased
38 (1.85%)
Liver Disorder
36 (1.75%)
Pyrexia
34 (1.65%)
White Blood Cell Count Decreased
33 (1.61%)
Alanine Aminotransferase Increased
30 (1.46%)
Toxic Epidermal Necrolysis
27 (1.31%)
Blood Creatine Phosphokinase Increa...
25 (1.22%)
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Pancytopenia
23 (1.12%)
Drug Interaction
21 (1.02%)
Stevens-johnson Syndrome
21 (1.02%)
Thrombocytopenia
20 (.97%)
Loss Of Consciousness
17 (.83%)
Disseminated Intravascular Coagulat...
16 (.78%)
Haemodialysis
16 (.78%)
Blood Lactate Dehydrogenase Increas...
15 (.73%)
Erythema
15 (.73%)
Jaundice
15 (.73%)
Rash
15 (.73%)
Renal Failure Acute
15 (.73%)
Renal Impairment
15 (.73%)
Anaemia
14 (.68%)
Blood Alkaline Phosphatase Increase...
14 (.68%)
Drug Eruption
14 (.68%)
Pneumonia
14 (.68%)
Blood Creatinine Increased
13 (.63%)
Diarrhoea
13 (.63%)
Gamma-glutamyltransferase Increased
13 (.63%)
Haemoglobin Decreased
13 (.63%)
Hypoaesthesia
13 (.63%)
Hyponatraemia
13 (.63%)
Agranulocytosis
12 (.58%)
Blood Urea Increased
12 (.58%)
Hyperkalaemia
12 (.58%)
C-reactive Protein Increased
11 (.54%)
Colitis Collagenous
11 (.54%)
Condition Aggravated
11 (.54%)
Haemorrhage Subcutaneous
10 (.49%)
Hepatitis Fulminant
10 (.49%)
Hypoglycaemia
10 (.49%)
International Normalised Ratio Incr...
10 (.49%)
Leukopenia
10 (.49%)
Skin Exfoliation
10 (.49%)
Vomiting
10 (.49%)
Blood Glucose Increased
9 (.44%)
Dyspnoea
9 (.44%)
Electrocardiogram Qt Prolonged
9 (.44%)
Haematuria
9 (.44%)
Lymphocyte Stimulation Test Positiv...
9 (.44%)
Myalgia
9 (.44%)
Nausea
9 (.44%)
Renal Failure
9 (.44%)
White Blood Cell Count Increased
9 (.44%)
Bradycardia
8 (.39%)
Granulocytopenia
8 (.39%)
Red Blood Cell Count Decreased
8 (.39%)
Stomatitis
8 (.39%)
Sudden Hearing Loss
8 (.39%)
Anxiety
7 (.34%)
Asthenia
7 (.34%)
Blood Bilirubin Increased
7 (.34%)
Convulsion
7 (.34%)
Drug Rash With Eosinophilia And Sys...
7 (.34%)
Eosinophil Count Increased
7 (.34%)
Gastric Ulcer Haemorrhage
7 (.34%)
Haematemesis
7 (.34%)
Haematocrit Decreased
7 (.34%)
Multi-organ Failure
7 (.34%)
Pleural Effusion
7 (.34%)
Pruritus
7 (.34%)
Purpura
7 (.34%)
Respiratory Failure
7 (.34%)
Blood Gastrin Increased
6 (.29%)
Blood Triglycerides Increased
6 (.29%)
Carcinoid Tumour Of The Duodenum
6 (.29%)
Cardiac Failure
6 (.29%)
Erythema Multiforme
6 (.29%)
Face Oedema
6 (.29%)
Hiatus Hernia
6 (.29%)
Neutrophil Count Decreased
6 (.29%)
Oxygen Saturation Decreased
6 (.29%)
Sepsis
6 (.29%)
Torsade De Pointes
6 (.29%)
Tubulointerstitial Nephritis
6 (.29%)
Urticaria
6 (.29%)
Anorexia
5 (.24%)
Basal Cell Carcinoma
5 (.24%)
Blood Pressure Decreased
5 (.24%)
Contusion
5 (.24%)
Disease Recurrence
5 (.24%)
Dizziness
5 (.24%)
Eczema
5 (.24%)
Fatigue
5 (.24%)
Gait Disturbance
5 (.24%)
Gastrointestinal Haemorrhage
5 (.24%)
Glucose Urine Present
5 (.24%)
Hepatic Steatosis
5 (.24%)
Hypokalaemia
5 (.24%)

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

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

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

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

Reflux Oesophagitis
308
Gastric Ulcer
249
Prophylaxis
168
Gastritis
108
Drug Use For Unknown Indication
73
Prophylaxis Against Gastrointestina...
73
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Gastrointestinal Haemorrhage
38
Gastric Ulcer Haemorrhage
32
Duodenal Ulcer
28
Gastritis Prophylaxis
28
Product Used For Unknown Indication
28
Helicobacter Infection
20
Gastrooesophageal Reflux Disease
17
Upper Gastrointestinal Haemorrhage
14
Abdominal Pain Upper
13
Ulcer
13
Stress Ulcer
12
Varices Oesophageal
10
Peptic Ulcer
9
Gastritis Atrophic
9
Oesophagitis
7
Gastric Ulcer Helicobacter
7
Haemorrhage Prophylaxis
7
Gastritis Erosive
6
Duodenal Ulcer Haemorrhage
6
Dyspepsia
5
Gastroduodenal Ulcer
4
Ileus
4
Gastric Haemorrhage
4
Gastric Disorder
4
Pancreatic Carcinoma
4
Gastrointestinal Disorder
4
Duodenal Ulcer Perforation
3
Anastomotic Ulcer
3
Decreased Appetite
3
Gastric Mucosal Lesion
3
Reflux Gastritis
3
Haemorrhagic Erosive Gastritis
3
Paroxysmal Nocturnal Haemoglobinuri...
3
Gastric Cancer
3
Crohns Disease
3
Gastritis Haemorrhagic
3
Pancreatitis Relapsing
3
Melaena
2
Multiple Myeloma
2
Diabetes Mellitus
2
Abdominal Discomfort
2
Pyloric Stenosis
2
Pancreatitis Acute
2
Enterocolitis
2
Stomach Discomfort
2

Omepral Case Reports

What Omepral 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 Omepral. 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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