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Index of reports
> Cases with Cytomegalovirus Infection (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Valcyte (Valganciclovir) where reactions include cytomegalovirus infection. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Valcyte side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: male
Reactions: Cytomegalovirus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Valcyte
Possible Valcyte side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: male
Reactions: Cytomegalovirus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Valcyte
Possible Valcyte side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16
Patient:
Reactions: Neuropathy Peripheral, Viral Infection, Fungal Infection, Cytomegalovirus Infection, Bacterial Infection, Leukopenia
Drug(s) suspected as cause:
Basiliximab
Indication: Immunosuppression
Cellcept
Administration route: Oral
Indication: Immunosuppression
Prednisone
Dosage: by 2 years post transplant
Prednisone
Indication: Immunosuppression
Tacrolimus
Dosage: first 3 months 14 ng/ml
Indication: Immunosuppression
Tacrolimus
Dosage: thereafter adjusted to 8-12 ng/ml
Valcyte
Administration route: Oral
Indication: Antiviral Prophylaxis
Possible Valcyte side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: male
Reactions: Malaise, Cytomegalovirus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Valcyte
Possible Valcyte side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: female, weighing 51.8 kg (114.0 pounds)
Reactions: Viral Infection, Anaemia, Cytomegalovirus Infection, Bacterial Infection, Toxicity To Various Agents
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 1mg; up to 8mg bid po
Administration route: Oral
Indication: Renal Transplant
Start date: 2011-09-01
End date: 2012-04-11
Valcyte
Dosage: 450mg od po
Administration route: Oral
Start date: 2011-09-01
Possible Valcyte side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: female, weighing 102.6 kg (225.7 pounds)
Reactions: Diarrhoea, Cytomegalovirus Infection, Leukopenia
Drug(s) suspected as cause:
Valcyte
Other drugs received by patient: Prednisone TAB; Mycophenolate Mofetil
Possible Valcyte side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-14
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Brain Herniation, Cytomegalovirus Infection, Diarrhoea Infectious
Adverse event resulted in: death
Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
Administration route: Oral
Mycophenolate Mofetil (Cellcept)
Indication: Product Used FOR Unknown Indication
Valcyte
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Hydrochlorothiazide; Valsartan; Prednisone TAB; Phenytoin; Calcium D3; Prograf; Acetaminophen; Hydrocodone Bitartrate and Acetaminophen; Bactrim; Metoprolol Succinate; Magnesium; Cyclosporine; Prilosec
Possible Valcyte side effects in
Reported by a individual with unspecified qualification from Spain on 2012-02-23
Patient:
Reactions: Drug Resistance, Cytomegalovirus Infection
Adverse event resulted in: death
Drug(s) suspected as cause:
Ganciclovir Sodium
Indication: Antiviral Prophylaxis
Valcyte
Administration route: Oral
Indication: Antiviral Prophylaxis
Possible Valcyte side effects in
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-09
Patient:
Reactions: Drug Resistance, Cytomegalovirus Infection, Treatment Failure
Drug(s) suspected as cause:
Cyclosporine
Indication: Prophylaxis Against Transplant Rejection
Mycophenolate Mofetil (Cellcept)
Indication: Prophylaxis Against Transplant Rejection
Tacrolimus
Indication: Prophylaxis Against Transplant Rejection
Valcyte
Administration route: Oral
Indication: Antiviral Prophylaxis
Possible Valcyte side effects in 78 year old female
Reported by a consumer/non-health professional from United States on 2012-01-24
Patient: 78 year old female
Reactions: Colitis Ulcerative, Cytomegalovirus Infection, Bursitis, Rash Pruritic
Drug(s) suspected as cause:
Prolia
Dosage: 60 mg, unk
Indication: Osteoporosis Postmenopausal
Start date: 2011-02-01
Valcyte
Dosage: unk
Indication: Cytomegalovirus Infection
Start date: 2011-05-01
End date: 2011-01-01
Other drugs received by patient: Asacol; Plavix; Oxybutynin; Acyclovir; Dermatologicals; Metoprolol Tartrate; Prednisolone; Levothyroxine Sodium; Celluvisc; Varicella-Zoster Immune Globulin (Human); Multi-Vitamins
Possible Valcyte side effects in female
Reported by a physician from Finland on 2011-12-29
Patient: female
Reactions: Anaemia, Hepatic Enzyme Increased, Interstitial Lung Disease, Diarrhoea, Staphylococcal Infection, Aspergillosis, Cytomegalovirus Infection, Neutropenia, Blood Creatinine Increased, Sinusitis, Thrombocytopenia, Soft Tissue Neoplasm, Herpes Virus Infection, Leukopenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Alemtuzumab
Indication: Chronic Lymphocytic Leukaemia
Cyclophosphamide
Indication: Chronic Lymphocytic Leukaemia
Fludarabine Phosphate
Indication: Chronic Lymphocytic Leukaemia
Foscavir
Indication: Cytomegalovirus Infection
Mabthera
Indication: Chronic Lymphocytic Leukaemia
Valcyte
Administration route: Oral
Indication: Cytomegalovirus Infection
Start date: 2010-04-26
Other drugs received by patient: Cyclosporine; Fluconazole; Emgesan; Valtrex; Ratiograstim; Lansoprazole; Prednisone TAB; Neulasta; Ceftazidime; Ribavirin; Hydrocortisone; Gensumycin; Ditrim Duplo; Multitabs; Calcium Carbonate; Adursal; Avelox; Tenox; Ceftriaxone; Mycophenolate Mofetil (Cellcept); Vitamin C; Ceftazidime; Medrol; Pulmicort; Zithromax; Diflucan
Possible Valcyte side effects in 62 year old male
Reported by a individual with unspecified qualification from Germany on 2011-11-29
Patient: 62 year old male
Reactions: Pneumonia, Diarrhoea, Benign Prostatic Hyperplasia, Cytomegalovirus Infection, Transplant Rejection, Pyelonephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
Start date: 2008-05-23
End date: 2008-05-23
Mycophenolate Mofetil (Cellcept)
Mycophenolate Mofetil (Cellcept)
Indication: Product Used FOR Unknown Indication
Start date: 2008-04-14
End date: 2008-05-15
Tacrolimus
Indication: Product Used FOR Unknown Indication
Start date: 2008-05-10
End date: 2008-05-15
Tacrolimus
Start date: 2008-05-20
End date: 2008-05-20
Tacrolimus
Tacrolimus
Start date: 2008-05-16
End date: 2008-05-16
Tacrolimus
Start date: 2008-05-17
End date: 2008-05-18
Tacrolimus
Start date: 2008-05-15
End date: 2008-05-15
Tacrolimus
Tacrolimus
Start date: 2008-05-19
End date: 2008-05-19
Valcyte
Administration route: Oral
Indication: Antiviral Prophylaxis
Other drugs received by patient: Neurontin; Amphotericin B; Pantoprazole; Metoprolol Tartrate; Antirheumatic Agent NOS; Prednisone TAB; Repaglinide; Actraphane; Cotrim DS; Neorecormon; Prednisone TAB; Avandia; Torsemide; Tamsulosin HCL; Ciprofloxacin
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