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VIRAMUNE

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Viramune Adverse Events Reported to the FDA Over Time

How are Viramune adverse event reports trending over time?

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

Most Common Viramune Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
420 (4.15%)
Pyrexia
213 (2.11%)
Abortion Spontaneous
202 (2%)
Rash
195 (1.93%)
Stillbirth
118 (1.17%)
Abortion Induced
108 (1.07%)
Stevens-johnson Syndrome
107 (1.06%)
Vomiting
106 (1.05%)
Alanine Aminotransferase Increased
96 (.95%)
Diarrhoea
81 (.8%)
Nausea
79 (.78%)
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Aspartate Aminotransferase Increase...
78 (.77%)
Premature Baby
76 (.75%)
Anaemia
75 (.74%)
Exomphalos
75 (.74%)
Pruritus
70 (.69%)
Pregnancy
67 (.66%)
Cardiac Malposition
66 (.65%)
Abdominal Pain
65 (.64%)
Hepatotoxicity
63 (.62%)
Pneumonia
63 (.62%)
Death
62 (.61%)
Hepatic Enzyme Increased
62 (.61%)
Jaundice
60 (.59%)
Liver Function Test Abnormal
60 (.59%)
Ascites
59 (.58%)
Diaphragmatic Aplasia
59 (.58%)
Headache
59 (.58%)
Microcephaly
57 (.56%)
Neutropenia
57 (.56%)
Rash Maculo-papular
57 (.56%)
Deformity Thorax
56 (.55%)
Asthenia
53 (.52%)
Caesarean Section
53 (.52%)
Maternal Drugs Affecting Foetus
53 (.52%)
Cytolytic Hepatitis
51 (.5%)
Hepatic Displacement
50 (.49%)
Myalgia
50 (.49%)
Hepatitis
49 (.48%)
Fatigue
48 (.47%)
Malaise
48 (.47%)
Small For Dates Baby
47 (.46%)
Osteonecrosis
46 (.46%)
Dyspnoea
45 (.45%)
Rash Generalised
45 (.45%)
Hepatic Failure
44 (.44%)
Pericardial Effusion
43 (.43%)
Congenital Anomaly
42 (.42%)
Hydrops Foetalis
42 (.42%)
Myocardial Infarction
41 (.41%)
Toxic Epidermal Necrolysis
40 (.4%)
Haemoglobin Decreased
39 (.39%)
Blood Amylase Increased
38 (.38%)
Death Neonatal
38 (.38%)
Gamma-glutamyltransferase Increased
38 (.38%)
Hypersensitivity
38 (.38%)
Methylmalonic Aciduria
37 (.37%)
Thrombocytopenia
37 (.37%)
Abdominal Distension
36 (.36%)
Lipodystrophy Acquired
36 (.36%)
Ventricular Septal Defect
35 (.35%)
Abdominal Pain Upper
34 (.34%)
Dehydration
34 (.34%)
Suicide Attempt
34 (.34%)
Lymphadenopathy
33 (.33%)
Underweight
33 (.33%)
Vitamin B12 Deficiency
33 (.33%)
Blood Alkaline Phosphatase Increase...
32 (.32%)
Blood Bilirubin Increased
32 (.32%)
Drug Resistance
31 (.31%)
Foetal Growth Retardation
31 (.31%)
Viral Load Increased
31 (.31%)
Cholestasis
30 (.3%)
Immune Reconstitution Syndrome
29 (.29%)
Trisomy 21
29 (.29%)
Foetal Disorder
28 (.28%)
Blood Creatine Phosphokinase Increa...
27 (.27%)
Congenital Hepatobiliary Anomaly
27 (.27%)
Developmental Delay
27 (.27%)
Metabolic Acidosis
27 (.27%)
Overdose
27 (.27%)
Acidosis
26 (.26%)
Cardiomyopathy
26 (.26%)
Dizziness
26 (.26%)
Laboratory Test Abnormal
26 (.26%)
Lactic Acidosis
26 (.26%)
Chills
25 (.25%)
Cytomegalovirus Infection
25 (.25%)
Depression
25 (.25%)
Intra-uterine Death
24 (.24%)
Pallor
24 (.24%)
Pancreatitis
24 (.24%)
Ultrasound Antenatal Screen Abnorma...
24 (.24%)
Adrenal Cyst
23 (.23%)
Alpha 1 Foetoprotein Increased
23 (.23%)
Cd4 Lymphocytes Increased
23 (.23%)
Hepatic Cirrhosis
23 (.23%)
Renal Failure Acute
23 (.23%)
Talipes
23 (.23%)
Umbilical Hernia
23 (.23%)
Weight Decreased
23 (.23%)

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

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

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

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

Hiv Infection
2290
Prophylaxis Against Hiv Infection
119
Drug Exposure During Pregnancy
114
Acquired Immunodeficiency Syndrome
89
Antiviral Treatment
76
Hiv Test Positive
53
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Vertical Infection Transmission
51
Human Immunodeficiency Virus Transm...
50
Antiviral Prophylaxis
48
Prophylaxis
41
Drug Use For Unknown Indication
41
Antiretroviral Therapy
39
Maternal Exposure During Pregnancy
31
Retroviral Infection
30
Acute Hiv Infection
10
Exposure To Communicable Disease
9
Product Used For Unknown Indication
8
Asymptomatic Hiv Infection
5
Hiv Infection Cdc Category A2
5
Infection Prophylaxis
4
Systemic Antiviral Treatment
3
Hiv Infection Cdc Group Iv Subgroup...
3
Maternal Condition Affecting Foetus
3
Herpes Simplex
3
Hiv Test
3
Congenital Hiv Infection
2
Taeniasis
2
Hiv Infection Cdc Group Iv Subgroup...
2
Immunodeficiency
2
Neonatal Infection
2
Cd4 Lymphocytes Decreased
2
Lentivirus Test Positive
2
Adverse Event
1
Hiv Infection Cdc Group I
1
Hiv Carrier
1
Prenatal Care
1
Hyperlipidaemia
1
Blood Hiv Rna Increased
1
Maternal Exposure Timing Unspecifie...
1
Encephalopathy
1
Hepatitis C
1

Drug Labels

LabelLabelerEffective
ViramuneState of Florida DOH Central Pharmacy21-MAY-10
ViramuneBoehringer Ingelheim Pharmaceuticals, Inc.15-NOV-12
ViramuneBoehringer Ingelheim Pharmaceuticals Inc.16-NOV-12
ViramunePhysicians Total Care, Inc.06-FEB-13

Viramune Case Reports

What Viramune 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 Viramune. 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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