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Digitek Adverse Events Reported to the FDA Over Time

How are Digitek adverse event reports trending over time?

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

Most Common Digitek Adverse Events Reported to the FDA

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

Dizziness
244 (7.48%)
Nausea
201 (6.16%)
Asthenia
115 (3.52%)
Fatigue
110 (3.37%)
Vomiting
102 (3.13%)
Hypotension
100 (3.06%)
Therapeutic Agent Toxicity
78 (2.39%)
Heart Rate Decreased
74 (2.27%)
Dyspnoea
73 (2.24%)
Diarrhoea
69 (2.11%)
Malaise
59 (1.81%)
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Fall
58 (1.78%)
Anorexia
51 (1.56%)
Heart Rate Irregular
51 (1.56%)
Confusional State
50 (1.53%)
Vision Blurred
44 (1.35%)
Heart Rate Increased
43 (1.32%)
Cardiac Disorder
41 (1.26%)
Palpitations
37 (1.13%)
Incorrect Dose Administered
35 (1.07%)
Feeling Abnormal
34 (1.04%)
Weight Decreased
28 (.86%)
Bradycardia
27 (.83%)
Headache
27 (.83%)
Loss Of Consciousness
26 (.8%)
Myocardial Infarction
25 (.77%)
Atrial Fibrillation
24 (.74%)
Blood Pressure Decreased
24 (.74%)
Cardiac Failure Congestive
23 (.7%)
Chest Pain
23 (.7%)
Cardioactive Drug Level Increased
22 (.67%)
Somnolence
22 (.67%)
Visual Impairment
22 (.67%)
Lethargy
20 (.61%)
Cardiac Arrest
18 (.55%)
Renal Failure
17 (.52%)
Arrhythmia
15 (.46%)
Cerebrovascular Accident
15 (.46%)
General Physical Health Deteriorati...
15 (.46%)
Balance Disorder
14 (.43%)
Depression
14 (.43%)
Gait Disturbance
14 (.43%)
Activities Of Daily Living Impaired
13 (.4%)
Blood Pressure Increased
13 (.4%)
Condition Aggravated
13 (.4%)
Fluid Retention
13 (.4%)
Pain
13 (.4%)
Swelling
13 (.4%)
Abdominal Pain Upper
12 (.37%)
Dehydration
12 (.37%)
Halo Vision
12 (.37%)
Oedema Peripheral
12 (.37%)
Product Quality Issue
12 (.37%)
Chest Discomfort
11 (.34%)
Overdose
11 (.34%)
Pain In Extremity
11 (.34%)
Syncope
11 (.34%)
Tremor
11 (.34%)
Cardiac Failure
10 (.31%)
Abdominal Pain
9 (.28%)
Blood Pressure Abnormal
9 (.28%)
Contusion
9 (.28%)
Death
9 (.28%)
Disorientation
9 (.28%)
Ill-defined Disorder
9 (.28%)
Medication Error
9 (.28%)
Sudden Death
9 (.28%)
Amnesia
8 (.25%)
Anxiety
8 (.25%)
Extrasystoles
8 (.25%)
Hyperhidrosis
8 (.25%)
Hypersomnia
8 (.25%)
Hypertension
8 (.25%)
Influenza Like Illness
8 (.25%)
Injury
8 (.25%)
Chromatopsia
7 (.21%)
Eye Disorder
7 (.21%)
Impaired Driving Ability
7 (.21%)
Insomnia
7 (.21%)
Renal Disorder
7 (.21%)
Renal Failure Acute
7 (.21%)
Vertigo
7 (.21%)
Decreased Appetite
6 (.18%)
Drug Level Increased
6 (.18%)
Dysstasia
6 (.18%)
Hallucination
6 (.18%)
Memory Impairment
6 (.18%)
Oxygen Saturation Decreased
6 (.18%)
Paraesthesia
6 (.18%)
Photopsia
6 (.18%)
Pollakiuria
6 (.18%)
Unevaluable Event
6 (.18%)
Abasia
5 (.15%)
Adverse Drug Reaction
5 (.15%)
Blood Potassium Decreased
5 (.15%)
Dizziness Postural
5 (.15%)
Drug Toxicity
5 (.15%)
Dysuria
5 (.15%)
Gastric Disorder
5 (.15%)
Heart Rate Abnormal
5 (.15%)
Joint Injury
5 (.15%)

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

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

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

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

Atrial Fibrillation
146
Cardiac Disorder
141
Cardiac Failure Congestive
80
Arrhythmia
52
Heart Rate Irregular
50
Cardiac Failure
49
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Drug Use For Unknown Indication
47
Heart Rate Increased
26
Product Used For Unknown Indication
19
Cardiomyopathy
9
Tachycardia
8
Supraventricular Tachycardia
7
Hypertension
6
Coronary Artery Bypass
6
Coronary Artery Disease
5
Heart Rate
5
Cardiac Valve Disease
5
Myocardial Infarction
5
Atrial Flutter
4
Heart Rate Abnormal
4
Atrial Tachycardia
4
Palpitations
4
Pulmonary Hypertension
3
Cardiac Operation
3
Ischaemic Cardiomyopathy
3
Heart Rate Decreased
3
Extrasystoles
3
Mitral Valve Prolapse
3
Vascular Graft
3
Transposition Of The Great Vessels
3
Heart Disease Congenital
3
Post Procedural Complication
2
Heart Valve Replacement
1
Pharmaceutical Product Complaint
1
Congenital Anomaly
1
Angioplasty
1
Deep Vein Thrombosis
1
Aortic Valve Replacement
1
Overdose
1
Arteriosclerosis Coronary Artery
1
Bundle Branch Block Left
1
Ischaemic Heart Disease Prophylaxis
1
Blood Pressure
1
Twin Pregnancy
1
Sick Sinus Syndrome
1
Pericardial Effusion
1
Drug Therapy
1
Tricuspid Valve Incompetence
1
Postoperative Care
1
Cardiac Assistance Device User
1
Congestive Cardiomyopathy
1

Digitek Case Reports

What Digitek 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 Digitek. 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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