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FALITHROM

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Falithrom Adverse Events Reported to the FDA Over Time

How are Falithrom adverse event reports trending over time?

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

Most Common Falithrom Adverse Events Reported to the FDA

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

Drug Interaction
81 (9.08%)
Gastrointestinal Haemorrhage
50 (5.61%)
Prothrombin Time Prolonged
22 (2.47%)
Alveolitis
20 (2.24%)
Deep Vein Thrombosis
16 (1.79%)
International Normalised Ratio Incr...
16 (1.79%)
Transaminases Increased
14 (1.57%)
Atrial Fibrillation
13 (1.46%)
Cardiac Failure
12 (1.35%)
Dehydration
12 (1.35%)
Dyspnoea
12 (1.35%)
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Pulmonary Embolism
12 (1.35%)
Abortion Induced
11 (1.23%)
Liver Disorder
11 (1.23%)
Epistaxis
10 (1.12%)
Hepatitis Toxic
10 (1.12%)
Hypertensive Crisis
10 (1.12%)
Nausea
10 (1.12%)
Single Umbilical Artery
10 (1.12%)
Tricuspid Valve Incompetence
10 (1.12%)
Vomiting
10 (1.12%)
Hyperglycaemia
9 (1.01%)
Pancreatitis Acute
9 (1.01%)
Fall
8 (.9%)
General Physical Health Deteriorati...
8 (.9%)
Maternal Drugs Affecting Foetus
8 (.9%)
Abdominal Pain
7 (.78%)
Haematuria
7 (.78%)
Haemoglobin Decreased
7 (.78%)
Hepatitis
7 (.78%)
Loss Of Consciousness
7 (.78%)
Overdose
7 (.78%)
Acute Hepatic Failure
6 (.67%)
Diarrhoea
6 (.67%)
Gamma-glutamyltransferase Increased
6 (.67%)
Gastritis Erosive
6 (.67%)
Hypokalaemia
6 (.67%)
Hyponatraemia
6 (.67%)
Oesophagitis Haemorrhagic
6 (.67%)
Activated Partial Thromboplastin Ti...
5 (.56%)
Bradycardia
5 (.56%)
Gingival Bleeding
5 (.56%)
Haematocrit Decreased
5 (.56%)
Hyperkalaemia
5 (.56%)
Oedema Peripheral
5 (.56%)
Pulmonary Congestion
5 (.56%)
Tachyarrhythmia
5 (.56%)
Abdominal Wall Haematoma
4 (.45%)
Alanine Aminotransferase Increased
4 (.45%)
Arrhythmia
4 (.45%)
Aspartate Aminotransferase Increase...
4 (.45%)
Blood Creatinine Increased
4 (.45%)
Blood Glucose Increased
4 (.45%)
C-reactive Protein Increased
4 (.45%)
Coagulopathy
4 (.45%)
Dialysis
4 (.45%)
Double Outlet Right Ventricle
4 (.45%)
Gastric Ulcer Helicobacter
4 (.45%)
Gastritis
4 (.45%)
Hypertension
4 (.45%)
Left Ventricular Failure
4 (.45%)
Lower Gastrointestinal Haemorrhage
4 (.45%)
Pleural Effusion
4 (.45%)
Pregnancy
4 (.45%)
Reflux Oesophagitis
4 (.45%)
Restlessness
4 (.45%)
Syncope
4 (.45%)
Upper Gastrointestinal Haemorrhage
4 (.45%)
Albumin Urine Present
3 (.34%)
Cerebrovascular Accident
3 (.34%)
Cholelithiasis
3 (.34%)
Decreased Appetite
3 (.34%)
Depression
3 (.34%)
Diverticulitis
3 (.34%)
Electrolyte Depletion
3 (.34%)
Faeces Discoloured
3 (.34%)
Gallbladder Non-functioning
3 (.34%)
Haematoma
3 (.34%)
Haemorrhagic Anaemia
3 (.34%)
Hypertransaminasaemia
3 (.34%)
Pain
3 (.34%)
Pneumonia
3 (.34%)
Prothrombin Time Shortened
3 (.34%)
Red Blood Cell Count Decreased
3 (.34%)
Subdural Haematoma
3 (.34%)
Suicidal Ideation
3 (.34%)
Abdominal Distension
2 (.22%)
Activated Partial Thromboplastin Ti...
2 (.22%)
Anaemia
2 (.22%)
Angiodysplasia
2 (.22%)
Asthenia
2 (.22%)
Blood Alkaline Phosphatase Increase...
2 (.22%)
Blood Potassium Decreased
2 (.22%)
Blood Urea Increased
2 (.22%)
Brain Compression
2 (.22%)
Brain Stem Haemorrhage
2 (.22%)
Cardio-respiratory Arrest
2 (.22%)
Cerebral Haemorrhage
2 (.22%)
Condition Aggravated
2 (.22%)
Confusional State
2 (.22%)
Coronary Artery Thrombosis
2 (.22%)

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

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

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

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

Atrial Fibrillation
194
Pulmonary Embolism
70
Tachyarrhythmia
42
Product Used For Unknown Indication
39
Thrombosis Prophylaxis
36
Aortic Valve Replacement
22
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Drug Use For Unknown Indication
17
Cardiac Failure
15
Peripheral Arterial Occlusive Disea...
10
Prophylaxis
10
Arrhythmia
9
Thrombosis
9
Cerebral Infarction
6
Atrial Flutter
5
Coronary Artery Disease
5
Ischaemic Heart Disease Prophylaxis
4
Mesenteric Vein Thrombosis
4
Thrombophlebitis Superficial
4
Activated Protein C Resistance Test
4
Venous Thrombosis
4
Cerebrovascular Accident
3
Deep Vein Thrombosis
3
Heart Valve Operation
3
Arrhythmia Prophylaxis
3
Pelvic Venous Thrombosis
3
Embolism
2
Pulmonary Arterial Hypertension
2
Cardiac Fibrillation
2
Cardiac Disorder
2
Infarction
1
Embolism Venous
1
Bradyarrhythmia
1
Vascular Graft
1
Coagulopathy
1
Aortic Surgery
1
Aortic Bypass
1
Mycosis Fungoides
1
Congestive Cardiomyopathy
1
Anticoagulant Therapy
1
Angiopathy
1
Heart Valve Replacement
1
Mitral Valve Disease
1

Falithrom Case Reports

What Falithrom 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 Falithrom. 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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