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ESOMEPRAZOLE MAGNESIUM

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Esomeprazole Magnesium Adverse Events Reported to the FDA Over Time

How are Esomeprazole Magnesium adverse event reports trending over time?

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

Most Common Esomeprazole Magnesium Adverse Events Reported to the FDA

What are the most common Esomeprazole Magnesium adverse events reported to the FDA?

Drug Dose Omission
9160 (6.88%)
Gastrooesophageal Reflux Disease
5300 (3.98%)
Malaise
3592 (2.7%)
Drug Ineffective
3308 (2.48%)
Dyspepsia
3009 (2.26%)
Osteoporosis
1951 (1.47%)
Vomiting
1883 (1.41%)
Abdominal Pain Upper
1733 (1.3%)
Pain
1687 (1.27%)
Abdominal Discomfort
1402 (1.05%)
Nausea
1357 (1.02%)
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Off Label Use
1352 (1.02%)
Intentional Drug Misuse
1326 (1%)
Multiple Fractures
1321 (.99%)
Diarrhoea
1152 (.87%)
Chest Pain
1081 (.81%)
Fall
1027 (.77%)
Headache
1007 (.76%)
Dyspnoea
993 (.75%)
Gastric Disorder
909 (.68%)
Insomnia
856 (.64%)
Aphagia
835 (.63%)
Dysphagia
731 (.55%)
Cerebrovascular Accident
726 (.55%)
Adverse Event
713 (.54%)
Cough
713 (.54%)
Diabetes Mellitus
707 (.53%)
Throat Irritation
695 (.52%)
Hypertension
691 (.52%)
Myocardial Infarction
690 (.52%)
Weight Decreased
677 (.51%)
Dizziness
651 (.49%)
Feeling Abnormal
651 (.49%)
Hiatus Hernia
641 (.48%)
Incorrect Dose Administered
638 (.48%)
Abdominal Pain
601 (.45%)
Pneumonia
585 (.44%)
Neoplasm Malignant
583 (.44%)
Depression
564 (.42%)
Fatigue
544 (.41%)
Nasopharyngitis
522 (.39%)
Inappropriate Schedule Of Drug Admi...
517 (.39%)
Back Pain
508 (.38%)
Pain In Extremity
501 (.38%)
Anxiety
495 (.37%)
Ulcer
473 (.36%)
Arthritis
471 (.35%)
Dysphonia
462 (.35%)
Flatulence
455 (.34%)
Asthma
443 (.33%)
Arthralgia
433 (.33%)
Cardiac Disorder
431 (.32%)
Constipation
424 (.32%)
Eructation
419 (.31%)
Abdominal Distension
417 (.31%)
Drug Interaction
414 (.31%)
Road Traffic Accident
414 (.31%)
Regurgitation
412 (.31%)
Asthenia
394 (.3%)
Chronic Obstructive Pulmonary Disea...
391 (.29%)
Oropharyngeal Pain
389 (.29%)
Muscle Spasms
377 (.28%)
Ill-defined Disorder
373 (.28%)
Death
354 (.27%)
Pyrexia
347 (.26%)
Rash
346 (.26%)
Dysgeusia
344 (.26%)
Bronchitis
341 (.26%)
Dry Mouth
341 (.26%)
Chest Discomfort
336 (.25%)
Drug Effect Decreased
331 (.25%)
Memory Impairment
331 (.25%)
Burning Sensation
330 (.25%)
Wrong Drug Administered
329 (.25%)
Oedema Peripheral
323 (.24%)
Pruritus
321 (.24%)
Condition Aggravated
320 (.24%)
Gastritis
318 (.24%)
Weight Increased
298 (.22%)
Choking
293 (.22%)
Gait Disturbance
281 (.21%)
Anaemia
279 (.21%)
Oesophageal Disorder
274 (.21%)
Renal Failure Acute
271 (.2%)
Blood Cholesterol Increased
269 (.2%)
Somnolence
265 (.2%)
Hernia
256 (.19%)
Gastric Ulcer
255 (.19%)
Confusional State
254 (.19%)
Thrombocytopenia
253 (.19%)
Osteoarthritis
237 (.18%)
Palpitations
237 (.18%)
Upper Limb Fracture
237 (.18%)
Decreased Appetite
235 (.18%)
Haemorrhage
235 (.18%)
Myalgia
234 (.18%)
Lower Limb Fracture
233 (.17%)
Cataract
232 (.17%)
Migraine
229 (.17%)
Haematemesis
222 (.17%)
Renal Failure
221 (.17%)

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

What are the most common Esomeprazole Magnesium adverse events reported to the FDA?

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

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

Gastrooesophageal Reflux Disease
10363
Drug Use For Unknown Indication
3051
Product Used For Unknown Indication
2453
Dyspepsia
1292
Gastric Disorder
745
Prophylaxis
736
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Gastritis
676
Hiatus Hernia
528
Prophylaxis Against Gastrointestina...
433
Gastric Ulcer
376
Ulcer
346
Barretts Oesophagus
340
Reflux Oesophagitis
299
Abdominal Discomfort
276
Abdominal Pain Upper
267
Oesophagitis
257
Gastrointestinal Disorder
181
Oesophageal Disorder
123
Peptic Ulcer
118
Erosive Oesophagitis
112
Ill-defined Disorder
112
Gastritis Prophylaxis
99
Hyperchlorhydria
96
Crohns Disease
94
Nausea
85
Reflux Gastritis
81
Helicobacter Infection
79
Duodenal Ulcer
78
Gastrointestinal Disorder Therapy
60
Osteoarthritis
56
Flatulence
55
Antacid Therapy
54
Stomach Discomfort
53
Abdominal Pain
52
Arthritis
51
Pain
50
Irritable Bowel Syndrome
48
Rheumatoid Arthritis
48
Dysphagia
45
Oesophageal Ulcer
45
Cough
42
Chest Pain
40
Gastric Ph Decreased
38
Gastrointestinal Haemorrhage
36
Vomiting
34
Gastrooesophageal Reflux Prophylaxi...
34
Hernia
33
Arthralgia
32
Gastritis Erosive
31
Impaired Gastric Emptying
30
Eructation
29

Drug Labels

LabelLabelerEffective
NexiumA-S Medication Solutions LLC04-SEP-09
NexiumSTAT RX USA LLC21-JUL-10
NexiumRebel Distributors Corp03-JAN-11
NexiumCardinal Health18-MAY-11
VimovoSTAT RX USA LLC29-JUL-11
NexiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC04-JAN-12
NexiumPhysicians Total Care, Inc.04-JAN-12
NexiumUnit Dose Services20-JAN-12
VimovoAstraZeneca LP09-OCT-12
NexiumAstraZeneca LP28-NOV-12
NexiumBryant Ranch Prepack21-JAN-13
NexiumBryant Ranch Prepack21-JAN-13
NexiumREMEDYREPACK INC. 22-FEB-13
NexiumCardinal Health29-APR-13

Esomeprazole Magnesium Case Reports

What Esomeprazole Magnesium 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 Esomeprazole Magnesium. 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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