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Vimovo Adverse Events Reported to the FDA Over Time

How are Vimovo adverse event reports trending over time?

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

Most Common Vimovo Adverse Events Reported to the FDA

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

Pain
69 (1.82%)
Drug Dose Omission
64 (1.69%)
Drug Ineffective
49 (1.29%)
Vomiting
45 (1.19%)
Drug Interaction
44 (1.16%)
Off Label Use
40 (1.05%)
Hyponatraemia
38 (1%)
Dyspnoea
37 (.98%)
Nausea
37 (.98%)
Renal Failure Acute
36 (.95%)
Arthritis
35 (.92%)
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Malaise
35 (.92%)
Diarrhoea
34 (.9%)
Abdominal Discomfort
33 (.87%)
Fall
32 (.84%)
Gastrooesophageal Reflux Disease
32 (.84%)
Thrombocytopenia
30 (.79%)
Dizziness
29 (.76%)
Pyrexia
29 (.76%)
Chest Pain
27 (.71%)
Abdominal Pain Upper
26 (.69%)
Arthralgia
25 (.66%)
Asthenia
25 (.66%)
Gastrointestinal Haemorrhage
25 (.66%)
Oedema Peripheral
25 (.66%)
Pain In Extremity
25 (.66%)
Confusional State
24 (.63%)
Cholestasis
21 (.55%)
Headache
21 (.55%)
Hypomagnesaemia
21 (.55%)
Pruritus
20 (.53%)
Urticaria
20 (.53%)
Dyspepsia
19 (.5%)
Gait Disturbance
19 (.5%)
Completed Suicide
18 (.47%)
Jaundice
18 (.47%)
Renal Failure
18 (.47%)
Back Pain
17 (.45%)
Muscle Spasms
17 (.45%)
Rash
17 (.45%)
Anaemia
16 (.42%)
Blood Creatinine Increased
16 (.42%)
Hypotension
16 (.42%)
Somnolence
16 (.42%)
Atrial Fibrillation
15 (.4%)
Hypertension
15 (.4%)
Weight Increased
15 (.4%)
Agranulocytosis
14 (.37%)
Fatigue
14 (.37%)
Gamma-glutamyltransferase Increased
14 (.37%)
Hypocalcaemia
14 (.37%)
Incorrect Dose Administered
14 (.37%)
Neutropenia
14 (.37%)
Blister
13 (.34%)
Feeling Abnormal
13 (.34%)
Inappropriate Schedule Of Drug Admi...
13 (.34%)
Palpitations
13 (.34%)
Renal Impairment
13 (.34%)
Blood Pressure Increased
12 (.32%)
Cytolytic Hepatitis
12 (.32%)
Diabetes Mellitus
12 (.32%)
Femur Fracture
12 (.32%)
Paraesthesia
12 (.32%)
Adverse Event
11 (.29%)
Drug Hypersensitivity
11 (.29%)
Drug Intolerance
11 (.29%)
Hiatus Hernia
11 (.29%)
Inflammation
11 (.29%)
Intentional Drug Misuse
11 (.29%)
Osteoarthritis
11 (.29%)
Rash Generalised
11 (.29%)
Anxiety
10 (.26%)
Blood Potassium Increased
10 (.26%)
Cerebrovascular Accident
10 (.26%)
Condition Aggravated
10 (.26%)
Cough
10 (.26%)
Dehydration
10 (.26%)
Epistaxis
10 (.26%)
Leukopenia
10 (.26%)
Musculoskeletal Pain
10 (.26%)
Rash Pruritic
10 (.26%)
Abdominal Pain
9 (.24%)
Adverse Drug Reaction
9 (.24%)
Blood Alkaline Phosphatase Increase...
9 (.24%)
Constipation
9 (.24%)
Death
9 (.24%)
Flatulence
9 (.24%)
Haematochezia
9 (.24%)
Hypokalaemia
9 (.24%)
Inappropriate Antidiuretic Hormone ...
9 (.24%)
Liver Function Test Abnormal
9 (.24%)
Loss Of Consciousness
9 (.24%)
Pneumonia
9 (.24%)
Rhabdomyolysis
9 (.24%)
Stevens-johnson Syndrome
9 (.24%)
Therapeutic Response Unexpected
9 (.24%)
Aphagia
8 (.21%)
Cardiac Arrest
8 (.21%)
Chronic Obstructive Pulmonary Disea...
8 (.21%)
Drug Prescribing Error
8 (.21%)
Dysphagia
8 (.21%)

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

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

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

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

Drug Use For Unknown Indication
742
Gastrooesophageal Reflux Disease
479
Product Used For Unknown Indication
236
Gastric Disorder
101
Dyspepsia
90
Prophylaxis Against Gastrointestina...
87
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Prophylaxis
74
Gastritis
64
Osteoarthritis
55
Arthritis
50
Hiatus Hernia
33
Pain
32
Arthralgia
31
Rheumatoid Arthritis
30
Gastric Ulcer
25
Peptic Ulcer
24
Ill-defined Disorder
20
Back Pain
20
Abdominal Discomfort
20
Crohns Disease
19
Oesophagitis
16
Abdominal Pain Upper
12
Ulcer
12
Helicobacter Infection
12
Gastritis Prophylaxis
11
Barretts Oesophagus
11
Antacid Therapy
10
Oesophageal Disorder
10
Stomach Discomfort
8
Nausea
8
Gastrooesophageal Reflux Prophylaxi...
8
Reflux Oesophagitis
8
Gastrointestinal Disorder
7
Musculoskeletal Pain
7
Inflammation
6
Hyperchlorhydria
6
Bursitis
6
Swelling
6
Reflux Gastritis
6
Neck Pain
6
Gastrointestinal Disorder Therapy
5
Peptic Ulcer Haemorrhage
5
Multiple Drug Overdose Intentional
4
Pain In Extremity
4
Myalgia
4
Gastroduodenal Ulcer
4
Tendonitis
4
Gout
4
Duodenal Ulcer
4
Irritable Bowel Syndrome
4
Cough
3

Drug Labels

LabelLabelerEffective
VimovoSTAT RX USA LLC29-JUL-11
VimovoAstraZeneca LP09-OCT-12

Vimovo Case Reports

What Vimovo 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 Vimovo. 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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