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Valcyte (Valganciclovir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Valcyte (Valganciclovir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (197)
Death (99)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Death (78)Diarrhoea (26)Cytomegalovirus Infection (12)Escherichia Urinary Tract Infection (10)Gastric Antral Vascular Ectasia (10)Anaemia Postoperative (10)Pancytopenia (10)Concomitant Disease Progression (10)Hospitalisation (9)Thrombocytopenia (9)Cytomegalovirus Viraemia (6)Neutropenia (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Valcyte (Valganciclovir). For a complete list or a specific selection of reports, please use the links above.

Possible Valcyte side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Hospitalisation, Herpes Zoster

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 2012-08-27

Patient: female, weighing 54.1 kg (119.0 pounds)

Reactions: Pneumonia Primary Atypical, Diarrhoea, Hypotension, Cytomegalovirus Viraemia, Pyrexia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Start date: 2011-02-03
    End date: 2011-09-09

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28
    End date: 2011-02-02

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-09-10
    End date: 2012-01-17

Leflunomide

Mycophenolate Mefetil
    Dosage: 250 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-24
    End date: 2012-01-29

Prednisone TAB
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28

Prednisone TAB
    Indication: Immunosuppression

Prograf
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28

Prograf
    Indication: Immunosuppression

Valcyte
    Dosage: 450 mg, bid
    Administration route: Oral
    Indication: Cytomegalovirus Viraemia
    Start date: 2011-08-25

Other drugs received by patient: Lasix



Possible Valcyte side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male, weighing 15.9 kg (35.1 pounds)

Reactions: Rotavirus Infection, Oral Infection, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valcyte

Other drugs received by patient: Mycophenolate Mefetil; Atenolol; Sulfamethoxazole Trimethoprim; Ramipril; Cyclosporine; Methylprednisolone; Natriumhydrogencarbonat



Possible Valcyte side effects in male

Reported by a physician from Germany on 2012-08-23

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Respiratory Failure, Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valcyte

Other drugs received by patient: Amoclav (United States); Amphotericin B; Amoclav (United States); Pantoprazole; Amlodipine



Possible Valcyte side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in 9 year old male

Reported by a physician from Germany on 2012-08-16

Patient: 9 year old male

Reactions: Pleural Effusion

Drug(s) suspected as cause:
Valcyte



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept
    Indication: Product Used FOR Unknown Indication

Valcyte
    Indication: Product Used FOR Unknown Indication



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 health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Diarrhoea, Escherichia Urinary Tract Infection, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone TAB
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone TAB
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran



Possible Valcyte side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Diarrhoea, Escherichia Urinary Tract Infection, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone TAB
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone TAB
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran

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