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GANCICLOVIR SODIUM

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Ganciclovir Sodium Adverse Events Reported to the FDA Over Time

How are Ganciclovir Sodium adverse event reports trending over time?

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

Most Common Ganciclovir Sodium Adverse Events Reported to the FDA

What are the most common Ganciclovir Sodium adverse events reported to the FDA?

Cytomegalovirus Infection
171 (3.74%)
Pancytopenia
83 (1.81%)
Renal Failure
80 (1.75%)
Drug Ineffective
71 (1.55%)
Multi-organ Failure
68 (1.49%)
Bone Marrow Failure
61 (1.33%)
Pyrexia
54 (1.18%)
Neutropenia
51 (1.11%)
Thrombocytopenia
50 (1.09%)
Leukopenia
49 (1.07%)
Anaemia
45 (.98%)
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Diarrhoea
44 (.96%)
Renal Failure Acute
44 (.96%)
Respiratory Failure
39 (.85%)
Sepsis
39 (.85%)
Transplant Rejection
37 (.81%)
Renal Impairment
35 (.76%)
Aspergillosis
34 (.74%)
Gastrointestinal Haemorrhage
34 (.74%)
Pneumonia
32 (.7%)
Hypotension
29 (.63%)
Blood Bilirubin Increased
27 (.59%)
White Blood Cell Count Decreased
27 (.59%)
Tachycardia
26 (.57%)
Dyspnoea
25 (.55%)
Confusional State
24 (.52%)
Cytomegalovirus Chorioretinitis
24 (.52%)
Cytomegalovirus Viraemia
24 (.52%)
Cholestasis
23 (.5%)
Abdominal Pain
22 (.48%)
Liver Disorder
22 (.48%)
Rash
22 (.48%)
General Physical Health Deteriorati...
21 (.46%)
Graft Versus Host Disease
21 (.46%)
Septic Shock
21 (.46%)
Anaphylactic Reaction
20 (.44%)
Nephropathy Toxic
20 (.44%)
Neutrophil Pelger-huet Anomaly Pres...
20 (.44%)
Abdominal Distension
19 (.42%)
Blood Creatinine Increased
19 (.42%)
Death
19 (.42%)
Hepatic Failure
19 (.42%)
Agranulocytosis
18 (.39%)
Anxiety
18 (.39%)
Fatigue
18 (.39%)
Hyperbilirubinaemia
18 (.39%)
Convulsion
17 (.37%)
Drug Toxicity
17 (.37%)
Haemodialysis
17 (.37%)
Neutrophil Count Decreased
17 (.37%)
Pain
17 (.37%)
Tachypnoea
17 (.37%)
Aspartate Aminotransferase Increase...
16 (.35%)
Lung Disorder
16 (.35%)
Platelet Count Decreased
16 (.35%)
Blood Lactate Dehydrogenase Increas...
15 (.33%)
Epstein-barr Virus Infection
15 (.33%)
Haemorrhage
15 (.33%)
Hallucination
15 (.33%)
Lactic Acidosis
15 (.33%)
Alanine Aminotransferase Increased
14 (.31%)
C-reactive Protein Increased
14 (.31%)
Cytomegalovirus Colitis
14 (.31%)
Deafness
14 (.31%)
Delirium
14 (.31%)
Diabetes Mellitus
14 (.31%)
Pneumonia Cytomegaloviral
14 (.31%)
Staphylococcal Infection
14 (.31%)
Thrombotic Thrombocytopenic Purpura
14 (.31%)
Condition Aggravated
13 (.28%)
Encephalitis Cytomegalovirus
13 (.28%)
Epstein-barr Virus Associated Lymph...
13 (.28%)
Febrile Neutropenia
13 (.28%)
Interstitial Lung Disease
13 (.28%)
Pneumocystis Jiroveci Pneumonia
13 (.28%)
Pulmonary Haemorrhage
13 (.28%)
Thrombotic Microangiopathy
13 (.28%)
Urinary Tract Infection
13 (.28%)
Ascites
12 (.26%)
Bronchopulmonary Aspergillosis
12 (.26%)
Dehydration
12 (.26%)
Escherichia Infection
12 (.26%)
Hepatic Enzyme Increased
12 (.26%)
Loss Of Consciousness
12 (.26%)
Somnolence
12 (.26%)
Tremor
12 (.26%)
Blood Alkaline Phosphatase Increase...
11 (.24%)
Bone Marrow Toxicity
11 (.24%)
Cytomegalovirus Enterocolitis
11 (.24%)
Cytomegalovirus Test
11 (.24%)
Disseminated Intravascular Coagulat...
11 (.24%)
Drug Resistance
11 (.24%)
Hepatic Function Abnormal
11 (.24%)
Hypotonia
11 (.24%)
Intestinal Perforation
11 (.24%)
Respiratory Distress
11 (.24%)
Shock
11 (.24%)
Vomiting
11 (.24%)
Weight Decreased
11 (.24%)
Acute Respiratory Distress Syndrome
10 (.22%)
Clostridium Difficile Colitis
10 (.22%)

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

What are the most common Ganciclovir Sodium adverse events reported to the FDA?

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

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

Cytomegalovirus Infection
315
Antiviral Prophylaxis
207
Drug Use For Unknown Indication
114
Product Used For Unknown Indication
92
Prophylaxis
83
Infection Prophylaxis
70
Show More Show More
Cytomegalovirus Chorioretinitis
57
Glioma
39
Cytomegalovirus Viraemia
29
Cytomegalovirus Colitis
24
Cytomegalovirus Test Positive
22
Cytomegalovirus Gastrointestinal In...
22
Pneumonia Cytomegaloviral
21
Cytomegalovirus Test
16
Cytomegalovirus Enterocolitis
14
Pneumonia
13
Cytomegalovirus Antigen Positive
11
Infection
10
Cytomegalovirus Oesophagitis
9
Encephalitis Cytomegalovirus
9
Antibiotic Prophylaxis
8
Epstein-barr Virus Infection
8
Oesophagitis
7
Epstein-barr Viraemia
6
Anti-infective Therapy
6
Prophylaxis Against Transplant Reje...
6
Oesophageal Ulcer
5
Immunosuppression
5
Viral Infection
5
Renal Transplant
5
Antiviral Treatment
5
Gastric Ulcer
5
Herpes Virus Infection
4
Antiretroviral Therapy
4
Herpes Zoster
4
Cytomegalovirus Enteritis
4
Ill-defined Disorder
4
Human Herpesvirus 6 Infection
4
Hiv Infection
4
T-cell Lymphoma
4
Lymphadenopathy
3
Pneumonia Viral
3
Immunosuppressant Drug Therapy
3
Prophylaxis Against Graft Versus Ho...
3
Cytomegalovirus Gastritis
3
Congenital Cytomegalovirus Infectio...
3
Adenovirus Infection
3
Encephalitis
3
Prophylactic Chemotherapy
3
Encephalitis Herpes
3
Cytomegalovirus Hepatitis
3

Drug Labels

LabelLabelerEffective
CytoveneivGenentech, Inc.03-AUG-10

Ganciclovir Sodium Case Reports

What Ganciclovir Sodium 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 Ganciclovir Sodium. 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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