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Cellcept (Mycophenolate Mofetil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cellcept (Mycophenolate Mofetil) 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 (489)
Death (129)
Life Threatening Events (32)
Disability (12)

Reports by Reaction Type

Death (82)Diarrhoea (25)Kidney Transplant Rejection (23)Anaemia (23)Transplant Rejection (20)Pneumonia (19)Urinary Tract Infection (13)Thrombocytopenia (12)Sepsis (12)Cytomegalovirus Infection (12)Neutropenia (12)Cerebrovascular Accident (11)

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

Possible Cellcept side effects in male

Reported by a consumer/non-health professional from China on 2012-08-24

Patient: male

Reactions: Weight Decreased, Portal Vein Thrombosis, Immunosuppressant Drug Level Increased, Gastric Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 250 mg, uid/qd
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2004-12-09

Tacrolimus
    Dosage: 1.5 mg, unknown/d
    Administration route: Oral
    Start date: 2004-12-09

Tacrolimus
    Dosage: unk
    Administration route: Oral
    Indication: Liver Transplant

Other drugs received by patient: Prednisone TAB



Possible Cellcept side effects in female

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

Patient: female

Reactions: Kidney Transplant Rejection

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in female

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

Patient: female

Reactions: Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Vertebroplasty

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept 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:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Cholangitis, Liver Transplant Rejection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in female

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

Patient: female

Reactions: Incontinence, Joint Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in male

Reported by a physician from France on 2012-08-20

Patient: male

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Bumetanide
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-28
    End date: 2012-03-06

Cellcept
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-27

Mabthera
    Indication: Product Used FOR Unknown Indication

Prednisone TAB
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-04
    End date: 2012-03-09

Prednisone TAB
    Start date: 2012-03-10
    End date: 2012-03-23

Prograf
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-27

Solu-Medrol
    Start date: 2012-03-01
    End date: 2012-03-03

Solu-Medrol
    Start date: 2012-02-28

Solu-Medrol
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-27

Other drugs received by patient: Irbesartan; Flixotide 250; Rosuvastatin



Possible Cellcept side effects in female

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

Patient: female

Reactions: Ankle Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in 28 year old male

Reported by a physician from France on 2012-08-20

Patient: 28 year old male

Reactions: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-07-08

Privigen
    Dosage: strength 100 mg/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-04
    End date: 2012-07-08

Other drugs received by patient: Mestinon; Olmesartan Medoxomil



Possible Cellcept side effects in

Reported by a physician from China on 2012-08-20

Patient:

Reactions: Graft Haemorrhage, Zygomycosis, Renal Necrosis

Drug(s) suspected as cause:
Cellcept

Other drugs received by patient: Glucocorticoid



Possible Cellcept side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female

Reactions: Renal Failure, Kidney Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Anaemia, Thrombocytopenia, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-05
    End date: 2012-08-12

Pegasys
    Indication: Hepatitis C
    Start date: 2012-06-15



Possible Cellcept side effects in male

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

Patient: male

Reactions: Metastatic Neoplasm, Hyperkeratosis, Squamous Cell Carcinoma, Skin Hypertrophy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept 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 Cellcept side effects in male

Reported by a physician from Brazil on 2012-08-20

Patient: male

Reactions: Graft Dysfunction, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Belatacept
    Indication: Renal Transplant
    Start date: 2007-04-04

Cellcept
    Indication: Renal Transplant
    Start date: 2007-04-04

Prednisone
    Indication: Renal Transplant
    Start date: 2007-04-06



Possible Cellcept side effects in male

Reported by a physician from India on 2012-08-20

Patient: male

Reactions: Periodontitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Belatacept
    Indication: Renal Transplant
    Start date: 2007-02-28

Cellcept
    Indication: Renal Transplant
    Start date: 2007-02-28

Prednisone
    Indication: Renal Transplant
    Start date: 2011-06-09

Other drugs received by patient: Nifedipine; Mixtard Human 70 / 30; Atenolol; Metformin Hydrochloride



Possible Cellcept side effects in 56 year old female

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

Patient: 56 year old female

Reactions: Chills, Hypotension, Pulmonary Oedema, Pleural Effusion, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Start date: 2011-01-01

Sprycel
    Dosage: interrupted and then restarted on 30 or 31jun11 with 70mg bid
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-02-01

Tacrolimus

Other drugs received by patient: Synthroid



Possible Cellcept side effects in male

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

Patient: male

Reactions: Renal Failure, Kidney Transplant Rejection

Drug(s) suspected as cause:
Cellcept



Possible Cellcept 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:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Graft Dysfunction, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Indication: Renal Transplant
    Start date: 2007-05-31

Cyclosporine
    Indication: Renal Transplant
    Start date: 2007-06-01

Other drugs received by patient: Pantoprazole Sodium



Possible Cellcept side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in female

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

Patient: female

Reactions: Heart Transplant Rejection

Drug(s) suspected as cause:
Cellcept



Possible Cellcept 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:
Cellcept



Possible Cellcept 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:
Cellcept



Possible Cellcept side effects in male

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

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept



Possible Cellcept side effects in female

Reported by a physician from China on 2012-08-17

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Emotional Distress, White Blood Cell Count Decreased, Tinnitus, Osteonecrosis, Insomnia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Cellcept
    Dosage: 500mg in the morning and 750mg in the evening
    Administration route: Oral

Cellcept
    Administration route: Oral

Cellcept
    Administration route: Oral

Cellcept
    Dosage: 250mg in the morning and 500mg in the evening
    Administration route: Oral

Cellcept
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-12-13
    End date: 2012-05-01

Prednisone TAB
    Dosage: reported as received in the morning.
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-12-13
    End date: 2008-01-01

Other drugs received by patient: Neoral



Possible Cellcept 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:
Cellcept

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