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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

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Emtricitabine And Tenofovir Disoproxil Fumarate Adverse Events Reported to the FDA Over Time

How are Emtricitabine And Tenofovir Disoproxil Fumarate adverse event reports trending over time?

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

Most Common Emtricitabine And Tenofovir Disoproxil Fumarate Adverse Events Reported to the FDA

What are the most common Emtricitabine And Tenofovir Disoproxil Fumarate adverse events reported to the FDA?

Abortion Spontaneous
134 (4.29%)
Drug Exposure During Pregnancy
108 (3.46%)
Ultrasound Antenatal Screen Abnorma...
39 (1.25%)
Pregnancy
38 (1.22%)
Renal Failure Acute
36 (1.15%)
Immune Reconstitution Syndrome
34 (1.09%)
Anaemia
31 (.99%)
Maternal Drugs Affecting Foetus
31 (.99%)
Premature Baby
28 (.9%)
Pyrexia
28 (.9%)
Death
25 (.8%)
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Congenital Teratoma
24 (.77%)
Stillbirth
23 (.74%)
Cardiac Murmur
22 (.7%)
Congenital Anomaly
22 (.7%)
Sepsis
22 (.7%)
Dehydration
20 (.64%)
Renal Failure
20 (.64%)
Diarrhoea
19 (.61%)
Exomphalos
19 (.61%)
Neutropenia
19 (.61%)
Leukopenia
18 (.58%)
Apnoea
17 (.54%)
Thrombocytopenia
17 (.54%)
Vomiting
17 (.54%)
Alanine Aminotransferase Increased
16 (.51%)
Hepatitis
16 (.51%)
Suicide Attempt
16 (.51%)
Ventricular Septal Defect
16 (.51%)
Abortion Induced
15 (.48%)
Aortic Valve Disease
15 (.48%)
Congenital Genital Malformation
15 (.48%)
Congenital Heart Valve Disorder
15 (.48%)
Sudden Infant Death Syndrome
15 (.48%)
Ventricular Hypertrophy
15 (.48%)
Abdominal Pain
14 (.45%)
Depression
14 (.45%)
Headache
14 (.45%)
Overdose
14 (.45%)
Renal Impairment
14 (.45%)
Anal Atresia
13 (.42%)
Bladder Agenesis
13 (.42%)
Blood Creatinine Increased
13 (.42%)
Completed Suicide
13 (.42%)
Gastroenteritis
13 (.42%)
Haemoglobin Decreased
13 (.42%)
Malaria
13 (.42%)
Mycobacterium Avium Complex Infecti...
13 (.42%)
Pulmonary Tuberculosis
13 (.42%)
Respiratory Distress
13 (.42%)
Suicidal Ideation
13 (.42%)
Weight Decreased
13 (.42%)
Aortic Valve Sclerosis
12 (.38%)
Asthenia
12 (.38%)
Cholecystitis
12 (.38%)
Drug Interaction
12 (.38%)
Large For Dates Baby
12 (.38%)
Pulmonary Valve Sclerosis
12 (.38%)
Trisomy 21
12 (.38%)
Aids Encephalopathy
11 (.35%)
Aspartate Aminotransferase Increase...
11 (.35%)
Blood Iron Decreased
11 (.35%)
Caesarean Section
11 (.35%)
Cardiac Arrest
11 (.35%)
Caudal Regression Syndrome
11 (.35%)
Cloacal Exstrophy
11 (.35%)
Congenital Pulmonary Valve Disorder
11 (.35%)
Eosinophilia
11 (.35%)
Genitalia External Ambiguous
11 (.35%)
Hypokalaemia
11 (.35%)
Meconium Stain
11 (.35%)
Meningomyelocele
11 (.35%)
Musculoskeletal Deformity
11 (.35%)
Tethered Cord Syndrome
11 (.35%)
Umbilical Cord Abnormality
11 (.35%)
Confusional State
10 (.32%)
Congenital Hydronephrosis
10 (.32%)
Cytomegalovirus Chorioretinitis
10 (.32%)
Drug Rash With Eosinophilia And Sys...
10 (.32%)
Lactic Acidosis
10 (.32%)
Nausea
10 (.32%)
Neonatal Respiratory Arrest
10 (.32%)
Patent Ductus Arteriosus
10 (.32%)
Psychotic Disorder
10 (.32%)
Respiratory Failure
10 (.32%)
Rhabdomyolysis
10 (.32%)
Spine Malformation
10 (.32%)
Erythema
9 (.29%)
Fatigue
9 (.29%)
Lymphadenopathy
9 (.29%)
Movement Disorder
9 (.29%)
Osteonecrosis
9 (.29%)
Skull Malformation
9 (.29%)
Blood Alkaline Phosphatase Increase...
8 (.26%)
Decreased Appetite
8 (.26%)
Drug Eruption
8 (.26%)
Fall
8 (.26%)
Hepatic Failure
8 (.26%)
Ileitis
8 (.26%)
Metabolic Acidosis
8 (.26%)
Pneumocystis Jiroveci Pneumonia
8 (.26%)

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This graph shows the top adverse events submitted to the FDA for Emtricitabine And Tenofovir Disoproxil Fumarate, 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 Emtricitabine And Tenofovir Disoproxil Fumarate 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 Emtricitabine And Tenofovir Disoproxil Fumarate

What are the most common Emtricitabine And Tenofovir Disoproxil Fumarate adverse events reported to the FDA?

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ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Emtricitabine And Tenofovir Disoproxil Fumarate, 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 Emtricitabine And Tenofovir Disoproxil Fumarate 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 Emtricitabine And Tenofovir Disoproxil Fumarate According to Those Reporting Adverse Events

Why are people taking Emtricitabine And Tenofovir Disoproxil Fumarate, according to those reporting adverse events to the FDA?

Hiv Infection
954
Drug Exposure During Pregnancy
81
Prophylaxis Against Hiv Infection
79
Product Used For Unknown Indication
34
Drug Use For Unknown Indication
15
Antiretroviral Therapy
10
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Human Immunodeficiency Virus Transm...
9
Hepatitis B
7
Hiv Test Positive
7
Antiviral Treatment
5
Acquired Immunodeficiency Syndrome
4
Maternal Exposure Timing Unspecifie...
3
Systemic Antiviral Treatment
3
Infection
3
Maternal Exposure During Pregnancy
2
Prophylaxis
1
Foetal Exposure During Pregnancy
1
Splenectomy
1

Drug Labels

LabelLabelerEffective
AtriplaState of Florida DOH Central Pharmacy12-MAR-10
TruvadaState of Florida DOH Central Pharmacy13-APR-10
TruvadaH.J. Harkins Company, Inc.14-DEC-11
TruvadaCardinal Health04-MAY-12
StribildGilead Sciences, Inc.28-AUG-12
AtriplaLake Erie Medical DBA Quality Care Products LLC13-NOV-12
TruvadaGilead Sciences, Inc15-JAN-13
AtriplaBristol Myers Squibb & Gilead Sciences, LLC16-JAN-13
CompleraGilead Sciences, Inc.31-JAN-13
TruvadaPhysicians Total Care, Inc.01-MAR-13
CompleraPhysicians Total Care, Inc.15-MAR-13
AtriplaREMEDYREPACK INC. 29-MAR-13
TruvadaREMEDYREPACK INC. 03-APR-13
TruvadaCardinal Health16-APR-13
AtriplaBristol Myers Squibb & Gilead Sciences, LLC23-APR-13
TruvadaCardinal Health24-APR-13
TruvadaCardinal Health24-APR-13

Emtricitabine And Tenofovir Disoproxil Fumarate Case Reports

What Emtricitabine And Tenofovir Disoproxil Fumarate 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 Emtricitabine And Tenofovir Disoproxil Fumarate. 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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