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ZIAGEN

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Ziagen Adverse Events Reported to the FDA Over Time

How are Ziagen adverse event reports trending over time?

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

Most Common Ziagen Adverse Events Reported to the FDA

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

Pyrexia
170 (3.3%)
Rash
87 (1.69%)
Drug Exposure During Pregnancy
75 (1.46%)
Nausea
75 (1.46%)
Diarrhoea
67 (1.3%)
Hypersensitivity
67 (1.3%)
Vomiting
65 (1.26%)
Myocardial Infarction
55 (1.07%)
Malaise
54 (1.05%)
Myalgia
53 (1.03%)
Fatigue
51 (.99%)
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Abdominal Pain
46 (.89%)
Thrombocytopenia
43 (.84%)
Headache
42 (.82%)
Dyspnoea
40 (.78%)
Hypoaesthesia
36 (.7%)
Drug Hypersensitivity
35 (.68%)
Weight Decreased
35 (.68%)
Alanine Aminotransferase Increased
33 (.64%)
Aspartate Aminotransferase Increase...
32 (.62%)
Blood Alkaline Phosphatase Increase...
32 (.62%)
Death
32 (.62%)
Hepatitis
32 (.62%)
Abortion Spontaneous
31 (.6%)
Asthenia
30 (.58%)
Blood Creatinine Increased
30 (.58%)
Haemolytic Anaemia
30 (.58%)
Pruritus
30 (.58%)
Thrombotic Thrombocytopenic Purpura
30 (.58%)
Arthralgia
29 (.56%)
Renal Failure Acute
29 (.56%)
Nervous System Disorder
28 (.54%)
Abortion Induced
27 (.52%)
Anaemia
27 (.52%)
Exomphalos
27 (.52%)
Blood Bilirubin Increased
26 (.51%)
General Physical Health Deteriorati...
26 (.51%)
Hypertension
25 (.49%)
Immune Reconstitution Syndrome
25 (.49%)
Liver Disorder
25 (.49%)
Pneumocystis Jiroveci Pneumonia
25 (.49%)
Renal Failure
25 (.49%)
Chest Pain
24 (.47%)
Renal Impairment
24 (.47%)
Drug Rash With Eosinophilia And Sys...
23 (.45%)
Lipodystrophy Acquired
23 (.45%)
Osteonecrosis
23 (.45%)
Abdominal Pain Upper
22 (.43%)
Cough
22 (.43%)
Platelet Count Decreased
22 (.43%)
Blood Creatine Phosphokinase Increa...
21 (.41%)
Blood Lactate Dehydrogenase Increas...
21 (.41%)
Pancytopenia
21 (.41%)
Coma
20 (.39%)
Gamma-glutamyltransferase Increased
20 (.39%)
Cardiac Malposition
19 (.37%)
Chills
19 (.37%)
Diabetes Mellitus
19 (.37%)
Diaphragmatic Aplasia
19 (.37%)
Erythema
19 (.37%)
Lymphadenopathy
19 (.37%)
Rhabdomyolysis
19 (.37%)
Transaminases Increased
19 (.37%)
Convulsion
18 (.35%)
Hepatotoxicity
18 (.35%)
Jaundice
18 (.35%)
Pain
18 (.35%)
Pancreatitis
18 (.35%)
Ascites
17 (.33%)
Cardiac Arrest
17 (.33%)
Deformity Thorax
17 (.33%)
Drug Interaction
17 (.33%)
Hepatic Displacement
17 (.33%)
Microcephaly
17 (.33%)
Pregnancy
17 (.33%)
Tachycardia
17 (.33%)
Hepatic Function Abnormal
16 (.31%)
Portal Hypertension
16 (.31%)
Renal Tubular Disorder
16 (.31%)
Agranulocytosis
15 (.29%)
Hepatomegaly
15 (.29%)
Neutropenia
15 (.29%)
Osteoporosis
15 (.29%)
Rash Generalised
15 (.29%)
Tachypnoea
15 (.29%)
White Blood Cell Count Decreased
15 (.29%)
Blood Triglycerides Increased
14 (.27%)
Confusional State
14 (.27%)
Dysphagia
14 (.27%)
Epilepsy
14 (.27%)
Liver Function Test Abnormal
14 (.27%)
Proteinuria
14 (.27%)
Renal Failure Chronic
14 (.27%)
Condition Aggravated
13 (.25%)
Depression
13 (.25%)
Dizziness
13 (.25%)
Haemorrhage Intracranial
13 (.25%)
Hepatic Cirrhosis
13 (.25%)
Hypotension
13 (.25%)
Pain In Extremity
13 (.25%)
Pericardial Effusion
13 (.25%)

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

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

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

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

Hiv Infection
1288
Acquired Immunodeficiency Syndrome
95
Drug Use For Unknown Indication
75
Product Used For Unknown Indication
33
Antiviral Treatment
27
Antiretroviral Therapy
27
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Drug Exposure During Pregnancy
14
Hiv Test Positive
12
Maternal Exposure Timing Unspecifie...
6
Ill-defined Disorder
6
Systemic Antiviral Treatment
5
Acute Hiv Infection
5
Infection
4
Viral Infection
4
Asymptomatic Hiv Infection
3
Foetal Exposure During Pregnancy
2
Kaposis Sarcoma Aids Related
2
Prophylaxis Against Hiv Infection
2
Nausea
2
Renal Impairment
1
Immunodeficiency
1
Hiv Infection Cdc Group Iii
1
Hiv Infection Cdc Category A2
1
Herpes Virus Infection
1

Drug Labels

LabelLabelerEffective
ZiagenState of Florida DOH Central Pharmacy13-APR-10
ZiagenGlaxoSmithKline LLC13-JUL-11
ZiagenViiV Healthcare Company21-MAY-12
ZiagenREMEDYREPACK INC. 08-APR-13

Ziagen Case Reports

What Ziagen 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 Ziagen. 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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