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Cellcept (Mycophenolate Mofetil) - Cytomegalovirus Infection - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Cytomegalovirus Infection (12)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cellcept (Mycophenolate Mofetil) where reactions include cytomegalovirus infection. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Cellcept side effects in

Reported by a physician from United States on 2012-07-20

Patient:

Reactions: Transplant Failure, Graft Versus Host Disease, Pseudomonas Infection, Mantle Cell Lymphoma, Herpes Zoster, Respiratory Syncytial Virus Infection, Chronic Lymphocytic Leukaemia Recurrent, Post Transplant Lymphoproliferative Disorder, Klebsiella Infection, Cytomegalovirus Infection, Sinusitis Fungal, Neutropenia, Influenza

Drug(s) suspected as cause:
Cyclosporine
    Dosage: on day 3 taper by 6 months
    Indication: Prophylaxis Against Graft Versus Host Disease

Cellcept
    Dosage: from day 0 to day 28 for related donors and day 100 for unrelated donors
    Indication: Prophylaxis Against Graft Versus Host Disease

Mabthera
    Dosage: on day 56, 63, 70, 77 post transplant: infusion: other indication chronic lymphocytic leukemia
    Indication: Mantle Cell Lymphoma

Other drugs received by patient: Anti-Thymocyte Globulin NOS



Possible Cellcept 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:
Tacrolimus
    Dosage: first 3 months 14 ng/ml
    Indication: Immunosuppression

Prednisone
    Dosage: by 2 years post transplant

Tacrolimus
    Dosage: thereafter adjusted to 8-12 ng/ml

Prednisone
    Indication: Immunosuppression

Valcyte
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Cellcept
    Administration route: Oral
    Indication: Immunosuppression

Basiliximab
    Indication: Immunosuppression



Possible Cellcept side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-09

Patient: male, weighing 64.0 kg (140.8 pounds)

Reactions: Hepatitis B Antibody Positive, Epstein-Barr Virus Infection, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal Large B-Cell Lymphoma, Cytomegalovirus Test Positive, Blood Uric Acid Increased, Cytomegalovirus Infection, Pyrexia, Hepatic Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simulect
    Dosage: 20 mg, once/single
    Start date: 2007-05-20
    End date: 2007-05-20

Cellcept
    Dosage: 1500 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-05-17

Neoral
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-05-13
    End date: 2007-05-23

Simulect
    Dosage: 20 mg, once/single
    Indication: Renal Transplant
    Start date: 2007-05-16
    End date: 2007-05-16

Other drugs received by patient: Sandimmune; Cinalong; Diovan; Solu-Medrol; Zyloric ^fresenius^; Prednisolone; Prednisolone; Allopurinol



Possible Cellcept side effects in male

Reported by a physician from France on 2012-07-05

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Renal Failure, Cytomegalovirus Infection, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Indication: Transplant Rejection
    Start date: 2011-01-29
    End date: 2012-01-19

Cyclosporine
    Indication: Transplant Rejection
    Start date: 2011-01-30



Possible Cellcept side effects in

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-06-20

Patient:

Reactions: Sepsis, Cytomegalovirus Infection, Human Polyomavirus Infection, Graft Loss

Adverse event resulted in: death

Drug(s) suspected as cause:
Tacrolimus

Prednisolone
    Dosage: for 2 days

Prednisolone
    Administration route: Oral

Prednisolone
    Indication: Prophylaxis Against Transplant Rejection

Azathioprine
    Indication: Prophylaxis Against Transplant Rejection

Azathioprine
    Administration route: Oral

Prednisolone
    Administration route: Oral

Tacrolimus
    Indication: Prophylaxis Against Transplant Rejection

Prednisolone
    Dosage: for 2 days

Cellcept
    Indication: Prophylaxis Against Transplant Rejection

Other drugs received by patient: Valtrex



Possible Cellcept side effects in female

Reported by a physician from Spain on 2012-06-15

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Urinary Tract Infection Enterococcal, Urinary Tract Infection, Cytomegalovirus Infection, Pyrexia, Lung Infiltration

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: current dose: 2000 mg

Cellcept
    Dosage: previous dose was 3000 mg
    Indication: Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis

Cellcept

Cellcept

Cellcept

Other drugs received by patient: Prednisone TAB; Prednisone TAB; Pravastatin; Amlodipine Besylate; Lorazepam; Prednisone TAB; Nitroglycerin; Omeprazole; Clopidogrel; Bisoprolol Fumarate; Enalapril; Aspirin; Azathioprine; Citalopram Hydrobromide; Prednisone TAB; Azathioprine; Enoxaparin; Alendronate Sodium; Cotrim; Prednisone TAB; Furosemide; Calcium / Vitamin D



Possible Cellcept side effects in male

Reported by a physician from Japan on 2012-06-15

Patient: male

Reactions: Colitis Ischaemic, Pneumonia, Abdominal Abscess, Cytomegalovirus Infection

Drug(s) suspected as cause:
Cellcept

Other drugs received by patient: Tacrolimus; Insulin; Basiliximab



Possible Cellcept side effects in 57 year old female

Reported by a physician from Japan on 2012-06-14

Patient: 57 year old female

Reactions: Acute Graft Versus Host Disease, Drug Ineffective, Pneumonia Bacterial, Cystitis Haemorrhagic, Cytomegalovirus Infection, Device Related Infection

Drug(s) suspected as cause:
Cellcept
    Dosage: unk
    Administration route: Oral
    Indication: Prophylaxis Against Graft Versus Host Disease

Cellcept
    Dosage: unk
    Administration route: Oral
    End date: 2010-12-01

Prograf
    Dosage: unk
    Administration route: Oral
    End date: 2010-12-01

Prograf
    Administration route: Oral
    Indication: Prophylaxis Against Graft Versus Host Disease



Possible Cellcept side effects in 32 year old female

Reported by a physician from Taiwan, Province of China on 2012-06-13

Patient: 32 year old female

Reactions: Cytomegalovirus Infection, Transplant Rejection

Drug(s) suspected as cause:
Prednisolone
    Start date: 2006-06-14
    End date: 2006-06-17

Cellcept
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2005-12-20
    End date: 2006-06-15

Cellcept
    Start date: 2006-06-14
    End date: 2006-06-17

Tacrolimus
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2005-12-20
    End date: 2006-06-20

Rapamune
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2005-12-20
    End date: 2006-06-17

Prednisolone
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2005-12-20
    End date: 2006-06-14



Possible Cellcept side effects in male

Reported by a physician from Serbia on 2012-05-31

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Cardiopulmonary Failure, Otitis Media, Cytomegalovirus Infection, Gastric Ulcer

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prednisolone
    Indication: Renal Transplant
    Start date: 2008-08-09

Tacrolimus
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2008-08-14

Cellcept
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2008-08-09

Other drugs received by patient: Ranisan; Ceftriaxone



Possible Cellcept side effects in female

Reported by a individual with unspecified qualification from Japan on 2012-05-10

Patient: female

Reactions: Post Transplant Lymphoproliferative Disorder, Gastric Cancer Stage 0, Anaemia, Cytomegalovirus Infection, Cerebellar Haemorrhage, Polyomavirus-Associated Nephropathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cellcept
    Administration route: Oral
    Start date: 2007-05-17
    End date: 2007-06-17

Tacrolimus
    Dosage: 2-14mg
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2007-05-02

Prednisolone
    Dosage: 5-10mg
    Administration route: Oral
    Start date: 2007-05-04

Cellcept
    Administration route: Oral
    Start date: 2007-07-08
    End date: 2008-02-01

Cellcept
    Administration route: Oral

Muromonab-CD3
    Dosage: dosage is uncertain.
    Indication: Renal and Pancreas Transplant Rejection
    Start date: 2007-12-01
    End date: 2007-12-01

Tacrolimus

Cellcept
    Administration route: Oral
    Start date: 2007-06-18
    End date: 2007-06-20

Prednisolone
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2007-04-27
    End date: 2007-05-03

Cellcept
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2007-05-02
    End date: 2007-05-10

Cellcept
    Administration route: Oral
    Start date: 2007-06-21
    End date: 2007-06-22

Cellcept
    Administration route: Oral
    Start date: 2008-02-01
    End date: 2008-10-01

Other drugs received by patient: Lantus; Novolin R; Insulin; Lansoprazole; Tacrolimus; Spanidin; Novorapid; Spanidin



Possible Cellcept side effects in 46 year old male

Reported by a physician from Japan on 2011-12-29

Patient: 46 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Pyrexia, Oropharyngeal Pain, Upper Respiratory Tract Inflammation, Hyperuricaemia, Oral Candidiasis, Nocardiosis, Serratia Test Positive, Asymptomatic Bacteriuria, Neurogenic Bladder, Urinary Tract Infection, Anaemia, Procedural Hypertension, Viral Upper Respiratory Tract Infection, Cytomegalovirus Chorioretinitis, Meningitis Cryptococcal, Cytomegalovirus Infection, Infection in AN Immunocompromised Host

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Prograf
    Dosage: 3 mg, bid, oral
    Administration route: Oral
    Indication: Immunosuppressant Drug Therapy
    Start date: 2006-07-18

Prednisolone
    Dosage: 5;20 mg, unknown/d, oral
    Administration route: Oral
    Indication: Immunosuppressant Drug Therapy
    Start date: 2006-07-15

Cellcept
    Dosage: 500;250 mg, unknown d, oral
    Administration route: Oral
    Indication: Immunosuppressant Drug Therapy
    Start date: 2006-07-12

Other drugs received by patient: Metoprolol Tartrate; Lansoprazole; Antifungals; Zantac; Diflucan; Basiliximab (Basiliximab); Amphotericin B; Ganciclovir; Fluconazole; Allopurinol; Amlodipine Besylate; Micardis; Ferromia (Ferrous Sodium Citrate); Urief (Silodosin); Avapro

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