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Cytovene Side Effects

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Common Cytovene Side Effects


The most commonly reported Cytovene side effects (click to view or check a box to report):

Death (11)
Kidney Transplant Rejection (3)
Renal Failure (3)
Cytomegalovirus Infection (3)
Haemorrhage (2)
Disease Progression (2)
Complications Of Transplanted Kidney (2)
Abdominal Pain Upper (2)
Hepatotoxicity (2)
Human Herpesvirus 6 Infection (2)
Platelet Count Decreased (2)
Liver Function Test Abnormal (2)
Hypotension (2)
Hyperammonaemia (2)
Immobile (1)
Hepatomegaly (1)
Kaposi's Sarcoma (1)
Pathogen Resistance (1)
Nephrolithiasis (1)
Multi-organ Failure (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Cytovene Side Effects Reported to FDA



Cytovene Side Effect Report#9994561
Sepsis, Multi-organ Failure, Shock, Subarachnoid Haemorrhage, Hyperammonaemia
This is a report of a 59-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: organ transplant, who was treated with Cytovene (dosage: NA, start time:
Nov 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Sepsis, Multi-organ Failure, Shock, Subarachnoid Haemorrhage, Hyperammonaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene treatment in male patients, resulting in Sepsis side effect.
Cytovene Side Effect Report#9988083
Renal Failure, Hyperammonaemia
This report suggests a potential Cytovene Renal Failure side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: lung transplant and used Cytovene (dosage: NA) starting
Dec 08, 2013. After starting Cytovene the patient began experiencing various side effects, including: Renal Failure, HyperammonaemiaAdditional drugs used concurrently:
  • Valcyte
The patient was hospitalized. Although Cytovene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Cytovene Side Effect Report#9132611
Hepatic Enzyme Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This Hepatic Enzyme Increased problem was reported by a pharmacist from US. A .0-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: congenital cytomegalovirus infection. On
Feb 17, 2013 this consumer started treatment with Cytovene Iv (dosage: NA). The following drugs were being taken at the same time:
  • Valcyte
  • Tpn
  • Phenobarbital
  • Phytonadione
  • Phytonadione
  • Phytonadione
When using Cytovene Iv, the patient experienced the following unwanted symptoms/side effects: Hepatic Enzyme Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Enzyme Increased, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#7064727-8
Concomitant Disease Aggravated, Cytomegalovirus Chorioretinitis
This Concomitant Disease Aggravated side effect was reported by a physician from United States. A 35-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cytovene (drug dosage: NA), which was initiated on
Jan 01, 1990. Concurrently used drugs:
  • Dapsone
  • Videx
.After starting to take Cytovene the consumer reported adverse symptoms, such as: Concomitant Disease Aggravated, Cytomegalovirus ChorioretinitisThese side effects may potentially be related to Cytovene.
Cytovene Side Effect Report#7064699-6
Acidosis, Hypotension
This is a report of a 38-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Cytovene (dosage: NA, start time:
Feb 07, 1990), combined with:
  • Erythromycin
  • Prednisone
  • Imipenem
  • H2 Blocker
  • Antibiotics Nos
and developed a serious reaction and side effect(s): Acidosis, Hypotension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene treatment in female patients, resulting in Acidosis side effect.
Cytovene Side Effect Report#6812828-9
Platelet Count Decreased, Platelet Count Increased
This report suggests a potential Cytovene Platelet Count Decreased side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Cytovene (dosage: Frequency: After Each Dialysis Treatment For 7 Days A Week.) starting
Mar 01, 2010. After starting Cytovene the patient began experiencing various side effects, including: Platelet Count Decreased, Platelet Count IncreasedAdditional drugs used concurrently:
  • Prednisone Tab
  • Bactrim
  • Itraconazole
The patient was hospitalized. Although Cytovene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Platelet Count Decreased, may still occur.
Cytovene Side Effect Report#6192672-9
Hepatotoxicity, Liver Function Test Abnormal
This Hepatotoxicity problem was reported by a physician from United States. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cytomegalovirus enteritis. On
Jan 22, 2009 this consumer started treatment with Cytovene Iv (dosage: Frequency: Q12). The following drugs were being taken at the same time:
  • Nexium
  • Heparin (Strength And Dose: 5000 Unit)
  • Claritin
  • Pseudovent Ped
  • Multivitamin/zinc (Dose: 220/256)
  • Tylenol
  • Imodium
  • Zofran
When using Cytovene Iv, the patient experienced the following unwanted symptoms/side effects: Hepatotoxicity, Liver Function Test AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatotoxicity, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#6180681-5
Hepatotoxicity, Liver Function Test Abnormal
This Hepatotoxicity side effect was reported by a physician from United States. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: cytomegalovirus enteritis.The patient was prescribed Cytovene Iv (drug dosage: Frequency: Q12), which was initiated on
Jan 22, 2009. Concurrently used drugs:
  • Nexium
  • Heparin (Strength And Dose: 5000 Unit)
  • Claritin
  • Pseudovent Ped
  • Multivitamin/zinc (Dose: 220/256)
  • Tylenol
  • Imodium
  • Zofran
.After starting to take Cytovene Iv the consumer reported adverse symptoms, such as: Hepatotoxicity, Liver Function Test AbnormalThese side effects may potentially be related to Cytovene Iv.
Cytovene Side Effect Report#6072521-X
Congenital Rubella Infection
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Cytovene Iv (dosage: 6mg/kg/dose Every 12 Hours (weight 4.2 Kg, Per Neofax 2008), start time:
Jan 08, 2009), combined with: NA. and developed a serious reaction and side effect(s): Congenital Rubella Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene Iv treatment in female patients, resulting in Congenital Rubella Infection side effect.
Cytovene Side Effect Report#5685044-4
Kidney Transplant Rejection, Nephrolithiasis, Renal Impairment
This report suggests a potential Cytovene Death side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Cytovene (dosage: NA) starting
Aug 01, 1998. After starting Cytovene the patient began experiencing various side effects, including: Kidney Transplant Rejection, Nephrolithiasis, Renal ImpairmentAdditional drugs used concurrently:
  • Trimethoprim
  • Cellcept
  • Prilosec
  • Clotrimazole
  • Prednisone Tab
  • Orthoclone Okt3
  • Atgam
The patient was hospitalized. Although Cytovene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Cytovene Side Effect Report#5685002-X
Communication Disorder, Confusional State, Cytomegalovirus Infection, Hallucination
This Communication Disorder problem was reported by a pharmacist from United States. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 21, 1997 this consumer started treatment with Cytovene (dosage: NA). The following drugs were being taken at the same time: NA. When using Cytovene, the patient experienced the following unwanted symptoms/side effects: Communication Disorder, Confusional State, Cytomegalovirus Infection, HallucinationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Communication Disorder, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#5684873-0
Kaposi's Sarcoma
This Kaposi's Sarcoma side effect was reported by a physician from United States. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cytovene Iv (drug dosage: NA), which was initiated on
Dec 02, 1992. Concurrently used drugs:
  • Adriamycin Pfs
  • Biaxin
  • Bleomycin Sulfate
  • Cipro
  • Hydrocortisone
  • Lamprene
  • Myambutol
  • Rifampin
.After starting to take Cytovene Iv the consumer reported adverse symptoms, such as: Kaposi's SarcomaThese side effects may potentially be related to Cytovene Iv.
Cytovene Side Effect Report#5684859-6
This is a report of a 31-year-old male patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Cytovene (dosage: NA, start time:
Jan 14, 1990), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene treatment in male patients, resulting in Death side effect.
Cytovene Side Effect Report#5684855-9
This report suggests a potential Cytovene Iv Death side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: NA and used Cytovene Iv (dosage: NA) starting
Aug 01, 1988. After starting Cytovene Iv the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Cytovene Iv demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Cytovene Side Effect Report#5684853-5
This Death problem was reported by a physician from Canada. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 06, 1989 this consumer started treatment with Cytovene (dosage: NA). The following drugs were being taken at the same time: NA. When using Cytovene, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#5684849-3
This Death side effect was reported by a physician from Canada. A 43-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cytovene (drug dosage: NA), which was initiated on
Aug 11, 1989. Concurrently used drugs: NA..After starting to take Cytovene the consumer reported adverse symptoms, such as: These side effects may potentially be related to Cytovene.
Cytovene Side Effect Report#5684751-7
This is a report of a 34-year-old male patient (weight: NA) from Brazil, suffering from the following health symptoms/conditions: NA, who was treated with Cytovene (dosage: NA, start time:
Nov 13, 1989), combined with:
  • Bactrim
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene treatment in male patients, resulting in Death side effect.
Cytovene Side Effect Report#5684749-9
This report suggests a potential Cytovene Death side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: pneumonia cytomegaloviral and used Cytovene (dosage: NA) starting
Jun 12, 1989. After starting Cytovene the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Cytovene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Cytovene Side Effect Report#5684747-5
This Death problem was reported by a physician from Brazil. A 25-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 08, 1989 this consumer started treatment with Cytovene Iv (dosage: NA). The following drugs were being taken at the same time:
  • Ketoconazole
  • Bactrim
When using Cytovene Iv, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#5565334-6
Acquired Immunodeficiency Syndrome, Disease Progression
This Acquired Immunodeficiency Syndrome side effect was reported by a physician from United States. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cytovene (drug dosage: Patient Receives 200 Mcg (.1 Ml / .3 Cc)), which was initiated on
Jan 01, 2001. Concurrently used drugs:
  • Videx
  • Kaletra
.After starting to take Cytovene the consumer reported adverse symptoms, such as: Acquired Immunodeficiency Syndrome, Disease ProgressionThese side effects may potentially be related to Cytovene.
Cytovene Side Effect Report#5425130-7
Abdominal Pain Upper, Acute Lymphocytic Leukaemia Recurrent, Ascites, Haemorrhage, Heart Rate Increased, Hepatic Function Abnormal, Hepatomegaly, Human Herpesvirus 6 Infection, Hypotension
This is a report of a 5-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: human herpesvirus 6 infection, who was treated with Cytovene Iv (dosage: NA, start time:
Feb 06, 2007), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain Upper, Acute Lymphocytic Leukaemia Recurrent, Ascites, Haemorrhage, Heart Rate Increased, Hepatic Function Abnormal, Hepatomegaly, Human Herpesvirus 6 Infection, Hypotension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene Iv treatment in female patients, resulting in Abdominal Pain Upper side effect. The patient was hospitalized.
Cytovene Side Effect Report#5385391-X
Abdominal Pain Upper, Haemorrhage, Human Herpesvirus 6 Infection, Immobile, Venoocclusive Disease
This report suggests a potential Cytovene Abdominal Pain Upper side effect(s) that can have serious consequences. A 5-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: human herpesvirus 6 infection and used Cytovene (dosage: NA) starting
Jan 01, 2007. After starting Cytovene the patient began experiencing various side effects, including: Abdominal Pain Upper, Haemorrhage, Human Herpesvirus 6 Infection, Immobile, Venoocclusive DiseaseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cytovene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Upper, may still occur.
Cytovene Side Effect Report#5125932-0
Renal Failure
This Renal Failure problem was reported by a health professional from United States. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cytomegalovirus infection,cytomegalovirus chorioretinitis. On
Jun 15, 1996 this consumer started treatment with Cytovene Iv (dosage: Intravenous). The following drugs were being taken at the same time: NA. When using Cytovene Iv, the patient experienced the following unwanted symptoms/side effects: Renal FailureThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure, may become evident only after a product is in use by the general population.
Cytovene Side Effect Report#4887786-7
Complications Of Transplanted Kidney, Haemodialysis, Haemoglobin Decreased, Kidney Transplant Rejection, Platelet Count Decreased, Renal Tubular Necrosis, Tubulointerstitial Nephritis, White Blood Cell Count Decreased
This Complications Of Transplanted Kidney side effect was reported by a pharmacist from United States. A 13-year-old male patient (weight:NA) experienced the following symptoms/conditions: cytomegalovirus infection,pain,anaemia.The patient was prescribed Cytovene Iv (drug dosage: Frequency Reported As: Q 48 Hr.), which was initiated on
Oct 15, 2005. Concurrently used drugs:
  • Fentanyl (Reported As Fentanyl Pca. Formulation Reported As: Various. Dosage Regimen Reported As Pca.)
  • Epogen (Stop Date Given As 02 Nov 2005 But Also Reported As Ongoing. Administered With Dialysis.)
  • Polygam (Frequency Reported As Q 48 Hr.)
  • Thymoglobulin (Frequency Reported As Q 24 Hr.)
.After starting to take Cytovene Iv the consumer reported adverse symptoms, such as: Complications Of Transplanted Kidney, Haemodialysis, Haemoglobin Decreased, Kidney Transplant Rejection, Platelet Count Decreased, Renal Tubular Necrosis, Tubulointerstitial Nephritis, White Blood Cell Count DecreasedThese side effects may potentially be related to Cytovene Iv. The patient was hospitalized and became disabled.
Cytovene Side Effect Report#4879177-X
Cytomegalovirus Infection, Gastrointestinal Disorder, Gene Mutation, Pathogen Resistance
This is a report of a 56-year-old male patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Cytovene Iv (dosage: NA, start time:
Jun 15, 2004), combined with: NA. and developed a serious reaction and side effect(s): Cytomegalovirus Infection, Gastrointestinal Disorder, Gene Mutation, Pathogen Resistance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cytovene Iv treatment in male patients, resulting in Cytomegalovirus Infection side effect. The patient was hospitalized.


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The appearance of Cytovene on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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Why Your Notes are Important

Your notes could be helpful in several ways:

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  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Cytovene reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Cytovene Side Effects

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    Cytovene Safety Alerts, Active Ingredients, Usage Information

    NDC0004-6940
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCytovene IV
    Nameganciclovir sodium
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteINTRAVENOUS
    On market since19890623
    LabelerGenentech, Inc.
    Active Ingredient(s)GANCICLOVIR SODIUM
    Strength(s)500
    Unit(s)mg/10mL
    Pharma ClassCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nuc

    More About Cytovene

    Side Effects reported to FDA: 27

    Cytovene safety alerts: 2002

    Reported deaths: 13

    Reported hospitalizations: 6

    Cytovene (gancyclovir)

    Audience: Pharmacists, other healthcare professionals

    Healthcare professionals advised of a critical shortage of Cytovene-IV, indicated for the treatment or prevention of cytomegalovirus (CMV) disease. This shortage in supply is expected to last through the second quarter of 2002. Roche urges physicians to explore alternative treatment therapies or management strategies for their patients. This temporary situation affects only the IV formulation of Cytovene.

    UPDATED:
    [March 13, 2002 - Letter - Roche]

    [Feb 13, 2002 - Letter - Roche]

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