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PENTOXIFYLLINE

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Pentoxifylline Adverse Events Reported to the FDA Over Time

How are Pentoxifylline adverse event reports trending over time?

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

Most Common Pentoxifylline Adverse Events Reported to the FDA

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

International Normalised Ratio Incr...
17 (1.74%)
Renal Failure Acute
16 (1.64%)
Drug Ineffective
14 (1.44%)
Drug Interaction
12 (1.23%)
Gastrointestinal Haemorrhage
12 (1.23%)
Hypotension
12 (1.23%)
Interstitial Lung Disease
12 (1.23%)
Anaemia
11 (1.13%)
Asthenia
11 (1.13%)
Dizziness
11 (1.13%)
Pyrexia
11 (1.13%)
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Alanine Aminotransferase Increased
10 (1.03%)
Overdose
10 (1.03%)
Thrombocytopenia
10 (1.03%)
Coma
9 (.92%)
Dehydration
9 (.92%)
Pulmonary Fibrosis
9 (.92%)
Cardiac Failure
8 (.82%)
Confusional State
8 (.82%)
Petechiae
8 (.82%)
Epistaxis
7 (.72%)
Haemoglobin Decreased
7 (.72%)
Oedema Peripheral
7 (.72%)
Sepsis
7 (.72%)
Cerebrovascular Accident
6 (.62%)
Condition Aggravated
6 (.62%)
Convulsion
6 (.62%)
Haematuria
6 (.62%)
Lung Disorder
6 (.62%)
Metabolic Acidosis
6 (.62%)
Mitral Valve Incompetence
6 (.62%)
Peripheral Vascular Disorder
6 (.62%)
Rectal Haemorrhage
6 (.62%)
Renal Failure
6 (.62%)
Blood Creatinine Increased
5 (.51%)
Cardiac Tamponade
5 (.51%)
Cerebral Haemorrhage
5 (.51%)
Contusion
5 (.51%)
Creatinine Renal Clearance Decrease...
5 (.51%)
Deafness
5 (.51%)
Dry Skin
5 (.51%)
Gingival Disorder
5 (.51%)
Haematoma
5 (.51%)
Intentional Overdose
5 (.51%)
Mental Status Changes
5 (.51%)
Pain In Extremity
5 (.51%)
Pleural Effusion
5 (.51%)
Prostate Cancer Recurrent
5 (.51%)
Respiratory Failure
5 (.51%)
Sinusitis
5 (.51%)
Syncope
5 (.51%)
Vasculitis
5 (.51%)
Adrenal Adenoma
4 (.41%)
Aortic Valve Incompetence
4 (.41%)
Bladder Mass
4 (.41%)
Blood Glucose Increased
4 (.41%)
Blood Pressure Increased
4 (.41%)
Chest Pain
4 (.41%)
Cough
4 (.41%)
Deep Vein Thrombosis
4 (.41%)
Dyspnoea
4 (.41%)
Fall
4 (.41%)
Gamma-glutamyltransferase Increased
4 (.41%)
Gastrointestinal Disorder
4 (.41%)
Headache
4 (.41%)
Hypokalaemia
4 (.41%)
Hyponatraemia
4 (.41%)
Liver Function Test Abnormal
4 (.41%)
Malaise
4 (.41%)
Medication Error
4 (.41%)
Muscle Haemorrhage
4 (.41%)
Muscle Spasms
4 (.41%)
Nasopharyngitis
4 (.41%)
Nuclear Magnetic Resonance Imaging ...
4 (.41%)
Pain
4 (.41%)
Pulmonary Arterial Hypertension
4 (.41%)
Pulmonary Embolism
4 (.41%)
Respiratory Distress
4 (.41%)
Sedation
4 (.41%)
Urinary Tract Infection
4 (.41%)
Uveitis
4 (.41%)
Abdominal Discomfort
3 (.31%)
Abdominal Pain
3 (.31%)
Abdominal Wall Haematoma
3 (.31%)
Agitation
3 (.31%)
Anticonvulsant Drug Level Below The...
3 (.31%)
Cholestasis
3 (.31%)
Crepitations
3 (.31%)
Cytolytic Hepatitis
3 (.31%)
Drug Exposure During Pregnancy
3 (.31%)
Drug Level Increased
3 (.31%)
Dyspnoea Exertional
3 (.31%)
Electrocardiogram Qt Prolonged
3 (.31%)
General Physical Health Deteriorati...
3 (.31%)
Haematocrit Decreased
3 (.31%)
Haemorrhage
3 (.31%)
Hypertension
3 (.31%)
Hypoxia
3 (.31%)
Inflammation
3 (.31%)
International Normalised Ratio Decr...
3 (.31%)
Lethargy
3 (.31%)

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

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

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

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

Drug Use For Unknown Indication
71
Product Used For Unknown Indication
70
Atrial Fibrillation
20
Peripheral Vascular Disorder
16
Cardiovascular Disorder
13
Diabetic Vascular Disorder
12
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Peripheral Arterial Occlusive Disea...
12
Intermittent Claudication
10
Thrombosis Prophylaxis
9
Multiple Sclerosis
9
Cardiovascular Insufficiency
9
Cerebrovascular Accident
8
Arteriosclerosis
7
Anticoagulant Therapy
7
Pulmonary Embolism
6
Dizziness
6
Angiopathy
6
Raynauds Phenomenon
6
Hypertension
6
Oedema
5
Arteriosclerosis Obliterans
5
Aplastic Anaemia
5
Poor Peripheral Circulation
5
Hepatic Enzyme Increased
4
Migraine
4
Platelet Adhesiveness Decreased
4
Influenza
4
Arrhythmia
4
Vasodilatation
3
Cardiomyopathy
3
Venous Insufficiency
3
Sudden Hearing Loss
3
Ill-defined Disorder
3
Muscle Spasms
3
Peripheral Occlusive Disease
3
Haemorrhage
2
Prophylaxis
2
Depression
2
Neuropathy
2
Drug Exposure During Pregnancy
2
Finger Amputation
2
Purpura
2
Arterial Disorder
2
Amnesia
2
Peripheral Ischaemia
2
Suicide Attempt
2
Limb Discomfort
2
Thrombophlebitis
2
Pulmonary Fibrosis
2
Cirrhosis Alcoholic
2
Pain In Extremity
2

Drug Labels

LabelLabelerEffective
PentoxifyllineMylan Pharmaceuticals Inc.19-DEC-06
PentoxifyllineBryant Ranch Prepack10-MAY-10
PentoxifyllineNCS HealthCare of KY, Inc dba Vangard Labs26-MAY-10
PentoxifyllineState of Florida DOH Central Pharmacy31-MAY-10
PentoxifyllineState of Florida DOH Central Pharmacy31-MAY-10
PentoxifyllineState of Florida DOH Central Pharmacy31-MAY-10
PentoxifyllinePD-Rx Pharmaceuticals, Inc.08-NOV-10
PentoxifyllineUDL Laboratories, Inc.28-JAN-11
PentoxifyllineSTAT RX USA LLC26-APR-11
PentoxifyllineCardinal Health18-MAY-11
PentoxifyllineCardinal Health25-MAY-11
PentoxifyllineCardinal Health21-JUN-11
PentoxifyllineGolden State Medical Supply, Inc.09-JAN-12
PentoxifyllineMcKesson Contract Packaging01-FEB-12
TrentalSanofi-Aventis U.S. LLC 08-JUN-12
PentoxifyllineMajor Pharmaceuticals20-JUL-12
PentoxifyllineTeva Pharmaceuticals USA Inc31-JUL-12
PentoxifyllinePhysicians Total Care, Inc.14-SEP-12
PentoxifyllinePreferred Pharmaceuticals, Inc.28-SEP-12
PentoxifyllineApotex Corp.21-FEB-13
PentoxifyllineCardinal Health27-MAR-13
PentoxifyllineREMEDYREPACK INC. 29-MAR-13

Pentoxifylline Case Reports

What Pentoxifylline 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 Pentoxifylline. 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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