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TENOFOVIR DISOPROXIL FUMARATE

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Tenofovir Disoproxil Fumarate Adverse Events Reported to the FDA Over Time

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

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

Most Common Tenofovir Disoproxil Fumarate Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
1263 (2.74%)
Abortion Spontaneous
906 (1.96%)
Renal Failure Acute
865 (1.87%)
Pregnancy
601 (1.3%)
Pyrexia
537 (1.16%)
Renal Failure
531 (1.15%)
Immune Reconstitution Syndrome
436 (.94%)
Vomiting
435 (.94%)
Anaemia
385 (.83%)
Diarrhoea
378 (.82%)
Premature Baby
371 (.8%)
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Blood Creatinine Increased
331 (.72%)
Nausea
322 (.7%)
Alanine Aminotransferase Increased
281 (.61%)
Asthenia
258 (.56%)
Aspartate Aminotransferase Increase...
254 (.55%)
Fanconi Syndrome Acquired
253 (.55%)
Lactic Acidosis
245 (.53%)
Weight Decreased
245 (.53%)
Stillbirth
238 (.52%)
Rash
228 (.49%)
Dehydration
223 (.48%)
Thrombocytopenia
221 (.48%)
Cardiac Murmur
217 (.47%)
Renal Tubular Disorder
207 (.45%)
Proteinuria
202 (.44%)
Abortion Induced
201 (.44%)
Abdominal Pain
200 (.43%)
Osteonecrosis
198 (.43%)
Maternal Drugs Affecting Foetus
196 (.42%)
Death
193 (.42%)
Blood Alkaline Phosphatase Increase...
191 (.41%)
Dyspnoea
191 (.41%)
Renal Impairment
190 (.41%)
Congenital Anomaly
183 (.4%)
Headache
182 (.39%)
Hepatitis
180 (.39%)
Caesarean Section
179 (.39%)
Ultrasound Antenatal Screen Abnorma...
177 (.38%)
Fatigue
175 (.38%)
Jaundice
173 (.37%)
Rhabdomyolysis
173 (.37%)
Haemoglobin Decreased
171 (.37%)
Sepsis
171 (.37%)
Abdominal Distension
163 (.35%)
Metabolic Acidosis
163 (.35%)
Cytolytic Hepatitis
162 (.35%)
Drug Interaction
161 (.35%)
Lipodystrophy Acquired
161 (.35%)
Osteoporosis
161 (.35%)
Viral Load Increased
159 (.34%)
Hypophosphataemia
158 (.34%)
Renal Tubular Necrosis
156 (.34%)
Pneumonia
154 (.33%)
Blood Bilirubin Increased
151 (.33%)
Confusional State
148 (.32%)
Cryptorchism
146 (.32%)
Drug Ineffective
146 (.32%)
Neutropenia
142 (.31%)
Depression
141 (.31%)
Nephrolithiasis
140 (.3%)
Pruritus
138 (.3%)
General Physical Health Deteriorati...
135 (.29%)
Pancytopenia
134 (.29%)
Myalgia
130 (.28%)
Gamma-glutamyltransferase Increased
126 (.27%)
Lymphadenopathy
126 (.27%)
Chest Pain
124 (.27%)
Blood Creatine Phosphokinase Increa...
123 (.27%)
Hypokalaemia
123 (.27%)
Pancreatitis
123 (.27%)
Ventricular Septal Defect
123 (.27%)
Myocardial Infarction
120 (.26%)
Arthralgia
118 (.26%)
Hypertension
118 (.26%)
Dizziness
117 (.25%)
Convulsion
116 (.25%)
Overdose
116 (.25%)
Malaise
112 (.24%)
Hepatic Cirrhosis
111 (.24%)
Pain In Extremity
110 (.24%)
Hepatic Failure
108 (.23%)
Oedema Peripheral
105 (.23%)
Premature Labour
105 (.23%)
Exomphalos
104 (.23%)
Fanconi Syndrome
102 (.22%)
Liver Disorder
101 (.22%)
Liver Function Test Abnormal
101 (.22%)
Abdominal Hernia
100 (.22%)
Diabetes Mellitus
100 (.22%)
Patent Ductus Arteriosus
100 (.22%)
Polydactyly
100 (.22%)
Drug Resistance
99 (.21%)
Hepatotoxicity
96 (.21%)
Hyperbilirubinaemia
95 (.21%)
Umbilical Cord Abnormality
95 (.21%)
Anorexia
94 (.2%)
Back Pain
93 (.2%)
Cough
90 (.19%)
Fall
90 (.19%)
Hepatic Steatosis
89 (.19%)

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

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

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

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

Hiv Infection
12342
Drug Exposure During Pregnancy
697
Hepatitis B
494
Drug Use For Unknown Indication
473
Antiretroviral Therapy
426
Product Used For Unknown Indication
394
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Acquired Immunodeficiency Syndrome
309
Prophylaxis Against Hiv Infection
284
Hiv Test Positive
183
Maternal Exposure Timing Unspecifie...
149
Antiviral Treatment
144
Maternal Exposure During Pregnancy
76
Prophylaxis
41
Human Immunodeficiency Virus Transm...
41
Systemic Antiviral Treatment
40
Retroviral Infection
34
Antiviral Prophylaxis
30
Hepatitis B Virus Test
28
Acute Hiv Infection
23
Hepatitis B Virus
22
Viral Infection
13
Infection
12
Hiv Test
11
Hepatitis
11
Asymptomatic Hiv Infection
11
Hepatic Cirrhosis
10
Foetal Exposure During Pregnancy
10
Hepatitis C
10
Hiv Infection Cdc Category A2
9
Ill-defined Disorder
9
Lentivirus Test Positive
8
Injury Associated With Device
7
Pathogen Resistance
7
Hepatitis C Virus Test
7
Hiv Infection Cdc Category C3
6
Lipodystrophy Acquired
6
Intentional Drug Misuse
6
Exposure To Communicable Disease
5
Urticaria
4
Hiv Infection Cdc Category B2
4
Hiv Infection Cdc Category B3
4
Blood Creatinine Increased
4
Pregnancy
3
Immune System Disorder
3
Hiv Wasting Syndrome
3
Chronic Hepatitis
3
Hiv Infection Cdc Group Iv Subgroup...
3
Splenectomy
3
Hepatitis B Surface Antigen
3
Immunodeficiency
3
Anti-infective Therapy
3

Drug Labels

LabelLabelerEffective
AtriplaState of Florida DOH Central Pharmacy12-MAR-10
TruvadaState of Florida DOH Central Pharmacy13-APR-10
VireadState of Florida DOH Central Pharmacy13-APR-10
VireadCardinal Health13-OCT-11
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
VireadGilead Sciences, Inc.15-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
VireadREMEDYREPACK INC. 28-MAR-13
AtriplaREMEDYREPACK INC. 29-MAR-13
TruvadaREMEDYREPACK INC. 03-APR-13
TruvadaCardinal Health16-APR-13
VireadCardinal Health17-APR-13
AtriplaBristol Myers Squibb & Gilead Sciences, LLC23-APR-13
TruvadaCardinal Health24-APR-13
TruvadaCardinal Health24-APR-13

Tenofovir Disoproxil Fumarate Case Reports

What 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 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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