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ENFUVIRTIDE

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Enfuvirtide Adverse Events Reported to the FDA Over Time

How are Enfuvirtide adverse event reports trending over time?

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

Most Common Enfuvirtide Adverse Events Reported to the FDA

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

Renal Failure Acute
45 (1.79%)
Diarrhoea
43 (1.71%)
Death
42 (1.67%)
Pyrexia
40 (1.59%)
Hiv Infection
37 (1.47%)
Drug Exposure During Pregnancy
36 (1.43%)
Anaemia
30 (1.2%)
Nausea
29 (1.16%)
Lipodystrophy Acquired
28 (1.12%)
Headache
26 (1.04%)
Mitochondrial Toxicity
25 (1%)
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Progressive External Ophthalmoplegi...
25 (1%)
Acquired Immunodeficiency Syndrome
24 (.96%)
Weight Decreased
24 (.96%)
Diplopia
23 (.92%)
Eyelid Ptosis
23 (.92%)
Immune Reconstitution Syndrome
23 (.92%)
Renal Failure
23 (.92%)
Dehydration
20 (.8%)
Drug Resistance
20 (.8%)
Vomiting
19 (.76%)
Aids Encephalopathy
18 (.72%)
Depression
17 (.68%)
Immunodeficiency
17 (.68%)
Drug Ineffective
16 (.64%)
Injection Site Reaction
16 (.64%)
Premature Baby
16 (.64%)
Rhabdomyolysis
16 (.64%)
Hypotension
15 (.6%)
Multiple-drug Resistance
15 (.6%)
Viral Mutation Identified
15 (.6%)
Abdominal Pain
14 (.56%)
Blood Alkaline Phosphatase Increase...
14 (.56%)
Fall
14 (.56%)
General Physical Health Deteriorati...
14 (.56%)
Dyspnoea
13 (.52%)
Abortion Spontaneous
12 (.48%)
Oesophageal Candidiasis
12 (.48%)
Cytolytic Hepatitis
11 (.44%)
Hepatitis C
11 (.44%)
Pancreatitis Acute
11 (.44%)
Alanine Aminotransferase Increased
10 (.4%)
Aspartate Aminotransferase Increase...
10 (.4%)
Bronchitis
10 (.4%)
Drug Hypersensitivity
10 (.4%)
Liver Disorder
10 (.4%)
Movement Disorder
10 (.4%)
Neutropenia
10 (.4%)
Subdural Haematoma
10 (.4%)
Virologic Failure
10 (.4%)
Blood Triglycerides Increased
9 (.36%)
Candidiasis
9 (.36%)
Convulsion
9 (.36%)
Drug Interaction
9 (.36%)
Hepatic Enzyme Increased
9 (.36%)
Pneumocystis Jiroveci Pneumonia
9 (.36%)
Cachexia
8 (.32%)
Caesarean Section
8 (.32%)
Cd4 Lymphocytes Decreased
8 (.32%)
Condition Aggravated
8 (.32%)
Deep Vein Thrombosis
8 (.32%)
Fatigue
8 (.32%)
Hypersensitivity
8 (.32%)
Jaundice
8 (.32%)
Pneumonia
8 (.32%)
Portal Hypertension
8 (.32%)
Pruritus
8 (.32%)
Sepsis
8 (.32%)
Syncope
8 (.32%)
Urinary Tract Infection
8 (.32%)
Acute Myocardial Infarction
7 (.28%)
Anorexia
7 (.28%)
Arthralgia
7 (.28%)
Ascites
7 (.28%)
Asthenia
7 (.28%)
Blood Hiv Rna Increased
7 (.28%)
Bradycardia
7 (.28%)
Cardiac Failure Congestive
7 (.28%)
Cholestasis
7 (.28%)
Coronary Artery Disease
7 (.28%)
Decreased Appetite
7 (.28%)
Hiv Wasting Syndrome
7 (.28%)
Hypertension
7 (.28%)
Hyponatraemia
7 (.28%)
Liver Function Test Abnormal
7 (.28%)
Multi-organ Failure
7 (.28%)
Myocardial Infarction
7 (.28%)
Pain In Extremity
7 (.28%)
Premature Rupture Of Membranes
7 (.28%)
Squamous Cell Carcinoma
7 (.28%)
Stress
7 (.28%)
Upper Gastrointestinal Haemorrhage
7 (.28%)
Acne
6 (.24%)
Anaemia Of Chronic Disease
6 (.24%)
Atrial Fibrillation
6 (.24%)
Blood Creatine Phosphokinase Increa...
6 (.24%)
Blood Potassium Increased
6 (.24%)
Cardiomegaly
6 (.24%)
Chronic Obstructive Pulmonary Disea...
6 (.24%)
Cytomegalovirus Infection
6 (.24%)
Diabetes Mellitus
6 (.24%)

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

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

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

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

Hiv Infection
620
Drug Use For Unknown Indication
81
Drug Exposure During Pregnancy
23
Acquired Immunodeficiency Syndrome
21
Antiretroviral Therapy
13
Human Immunodeficiency Virus Transm...
6
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Systemic Antiviral Treatment
6
Prophylaxis
6
Product Used For Unknown Indication
6
End Stage Aids
6
Maternal Exposure During Pregnancy
4
Antiviral Prophylaxis
3
Hepatitis C
2
Retroviral Infection
2
Pneumonia
2
Hiv Test Positive
1
Urticaria
1
Ill-defined Disorder
1
Psoriasis
1

Drug Labels

LabelLabelerEffective
FuzeonGenentech, Inc.22-AUG-12

Enfuvirtide Case Reports

What Enfuvirtide 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 Enfuvirtide. 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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