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VALGANCICLOVIR

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Valganciclovir Adverse Events Reported to the FDA Over Time

How are Valganciclovir adverse event reports trending over time?

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

Most Common Valganciclovir Adverse Events Reported to the FDA

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

Death
172 (3.11%)
Pancytopenia
151 (2.73%)
Cytomegalovirus Infection
144 (2.6%)
Leukopenia
112 (2.02%)
Bone Marrow Failure
90 (1.63%)
Neutropenia
86 (1.55%)
Diarrhoea
85 (1.53%)
Pyrexia
80 (1.44%)
Thrombocytopenia
70 (1.26%)
White Blood Cell Count Decreased
56 (1.01%)
Anaemia
55 (.99%)
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Pneumonia
54 (.98%)
Transplant Rejection
54 (.98%)
C-reactive Protein Increased
49 (.88%)
Cytomegalovirus Chorioretinitis
48 (.87%)
Sepsis
48 (.87%)
Renal Impairment
47 (.85%)
Agranulocytosis
45 (.81%)
Blood Creatinine Increased
38 (.69%)
Haemoglobin Decreased
37 (.67%)
Renal Failure
37 (.67%)
Loss Of Consciousness
36 (.65%)
Renal Failure Acute
36 (.65%)
Platelet Count Decreased
35 (.63%)
Disseminated Intravascular Coagulat...
34 (.61%)
Pneumothorax
33 (.6%)
Febrile Neutropenia
32 (.58%)
Encephalitis
31 (.56%)
Cytomegalovirus Viraemia
30 (.54%)
Neutrophil Count Decreased
30 (.54%)
Acute Respiratory Failure
29 (.52%)
Hyperuricaemia
29 (.52%)
Multi-organ Failure
29 (.52%)
Cerebral Toxoplasmosis
28 (.51%)
Eating Disorder
28 (.51%)
Liver Disorder
27 (.49%)
Nausea
27 (.49%)
Respiratory Arrest
27 (.49%)
Vomiting
27 (.49%)
Drug Interaction
26 (.47%)
Hypoalbuminaemia
26 (.47%)
Immune Reconstitution Syndrome
25 (.45%)
Renal Tubular Necrosis
24 (.43%)
Staphylococcal Sepsis
24 (.43%)
Neural Tube Defect
23 (.42%)
Rash
20 (.36%)
Abortion Spontaneous
19 (.34%)
Decreased Appetite
19 (.34%)
General Physical Health Deteriorati...
19 (.34%)
Haemolytic Anaemia
19 (.34%)
Shock
19 (.34%)
Asthenia
18 (.33%)
Drug Exposure During Pregnancy
18 (.33%)
Hyperlipidaemia
18 (.33%)
Hyponatraemia
18 (.33%)
Respiratory Failure
18 (.33%)
Urinary Tract Infection
18 (.33%)
Congenital Anomaly
17 (.31%)
Dehydration
17 (.31%)
Mycobacterium Avium Complex Infecti...
17 (.31%)
Placental Infarction
17 (.31%)
Staphylococcal Infection
17 (.31%)
Umbilical Cord Abnormality
17 (.31%)
Weight Decreased
17 (.31%)
Anaemia Postoperative
16 (.29%)
Concomitant Disease Progression
16 (.29%)
Congenital Foot Malformation
16 (.29%)
Drug Ineffective
16 (.29%)
Escherichia Urinary Tract Infection
16 (.29%)
Osteonecrosis
16 (.29%)
Pneumocystis Jiroveci Pneumonia
16 (.29%)
Urosepsis
16 (.29%)
Blood Alkaline Phosphatase Increase...
15 (.27%)
Electrolyte Imbalance
15 (.27%)
Gastric Antral Vascular Ectasia
15 (.27%)
Hypertriglyceridaemia
15 (.27%)
Thrombotic Microangiopathy
15 (.27%)
Interstitial Lung Disease
14 (.25%)
Myopathy
14 (.25%)
Septic Shock
14 (.25%)
Cerebrovascular Accident
13 (.23%)
Fatigue
13 (.23%)
Headache
13 (.23%)
Hyperbilirubinaemia
13 (.23%)
Large Intestinal Ulcer
13 (.23%)
Malaise
13 (.23%)
Pseudomonas Infection
13 (.23%)
Tubulointerstitial Nephritis
13 (.23%)
Anal Atresia
12 (.22%)
Bronchopulmonary Aspergillosis
12 (.22%)
Confusional State
12 (.22%)
Congenital Central Nervous System A...
12 (.22%)
Cytomegalovirus Test Positive
12 (.22%)
Dyspnoea
12 (.22%)
Hyperthermia
12 (.22%)
Musculoskeletal Stiffness
12 (.22%)
Angioimmunoblastic T-cell Lymphoma
11 (.2%)
Arrhythmia
11 (.2%)
Atypical Mycobacterial Infection
11 (.2%)
Blood Immunoglobulin G Decreased
11 (.2%)
Cardiac Arrest
11 (.2%)

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

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

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

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

Product Used For Unknown Indication
322
Cytomegalovirus Infection
308
Drug Use For Unknown Indication
228
Antiviral Prophylaxis
227
Prophylaxis
138
Cytomegalovirus Chorioretinitis
112
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Infection Prophylaxis
100
Renal Transplant
37
Hiv Infection
25
Encephalitis Cytomegalovirus
21
Cytomegalovirus Viraemia
19
Transplant
15
Infection
12
Prophylaxis Against Transplant Reje...
12
Systemic Antiviral Treatment
12
Drug Exposure During Pregnancy
12
Cytomegalovirus Test Positive
11
Viral Test Positive
10
Cytomegalovirus Enterocolitis
8
Castlemans Disease
8
Anaemia
7
Lung Transplant
7
Viral Infection
7
Antiviral Treatment
7
Small Intestine Transplant
6
Cytomegalovirus Oesophagitis
6
Anti-infective Therapy
6
Opportunistic Infection Prophylaxis
6
Cytomegalovirus Colitis
6
Oesophageal Ulcer
5
Cytomegalovirus Test
5
Liver Transplant
5
Gastric Ulcer
5
Pneumonia Cytomegaloviral
5
Ill-defined Disorder
4
Chronic Fatigue Syndrome
4
Heart Transplant
4
Cytomegalovirus Antigen Positive
3
Antibiotic Prophylaxis
3
Chemotherapy
3
Transplant Rejection
3
Kidney Transplant Rejection
3
Epstein-barr Virus Infection
3
Cytomegalovirus Gastrointestinal In...
3
Epstein-barr Viraemia
3
Immunosuppression
2
Maternal Exposure During Pregnancy
2
Pancreas Transplant
2
Cytomegalovirus Enteritis
2
Multiple Myeloma
2
Antifungal Prophylaxis
2

Drug Labels

LabelLabelerEffective
ValcyteGenentech, Inc.31-MAR-13

Valganciclovir Case Reports

What Valganciclovir 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 Valganciclovir. 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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