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Myfortic (Mycophenolic Acid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Myfortic (Mycophenolic Acid) 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 (501)
Death (41)
Life Threatening Events (25)
Disability (4)

Reports by Reaction Type

Kidney Transplant Rejection (56)Blood Creatinine Increased (40)Diarrhoea (37)Nausea (31)Vomiting (30)Pyrexia (29)Renal Failure (28)Death (25)Renal Failure Acute (24)Urinary Tract Infection (22)Diabetes Mellitus (21)Anaemia (19)

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

Possible Myfortic side effects in female

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: female

Reactions: Brain Injury, Oral Administration Complication, Drug Administration Error, Mastication Disorder, Cerebrovascular Accident

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in 62 year old female

Reported by a physician from United States on 2012-08-23

Patient: 62 year old female, weighing 62.3 kg (137.1 pounds)

Reactions: Small Intestinal Obstruction, Respiratory Failure, Post Procedural Complication, Enterocutaneous Fistula, Mental Status Changes Postoperative, Lower Gastrointestinal Haemorrhage, Abdominal Adhesions

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 360 mg, bid, oral
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2006-01-01
    End date: 2012-07-26

Zortress
    Dosage: 0.75 mg, bid, oral
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-06-19
    End date: 2012-07-26

Other drugs received by patient: Prednisone; Glipizide



Possible Myfortic side effects in male

Reported by a physician from Australia on 2012-08-21

Patient: male, weighing 103.0 kg (226.6 pounds)

Reactions: Staphylococcal Infection, Device Related Infection, Cyst, Arthritis, Concomitant Disease Progression, Haematoma, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2008-12-02

Neoral
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2008-12-16
    End date: 2008-12-17

Neoral
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2008-12-24
    End date: 2009-02-02

Neoral
    Dosage: 550 mg, unk
    Administration route: Oral
    Start date: 2008-12-23
    End date: 2008-12-23

Neoral
    Dosage: 900 mg, unk
    Administration route: Oral
    Start date: 2008-12-03
    End date: 2008-12-03

Neoral
    Dosage: 300 mg, unk
    Administration route: Oral
    Start date: 2008-12-18
    End date: 2008-12-18

Neoral
    Dosage: 750 mg, unk
    Administration route: Oral
    Start date: 2008-12-08
    End date: 2008-12-08

Neoral
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2008-12-02
    End date: 2008-12-02

Neoral
    Dosage: 800 mg, unk
    Administration route: Oral
    Start date: 2008-12-04
    End date: 2008-12-07

Neoral
    Dosage: 700 mg, unk
    Administration route: Oral
    Start date: 2008-12-09
    End date: 2008-12-15

Neoral
    Dosage: 600 mg, unk
    Administration route: Oral
    Start date: 2008-12-19
    End date: 2008-12-22

Neoral
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2009-02-03

NO Treatment Received
    Dosage: no treatment
    Indication: Renal Transplant

Other drugs received by patient: Basiliximab; Methylprednisolone; Prednisone; Methylprednisolone



Possible Myfortic side effects in male

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

Patient: male

Reactions: Meniscus Lesion, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in 37 year old female

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

Patient: 37 year old female

Reactions: Abdominal Discomfort, Complications of Transplanted Pancreas, Nausea, Dizziness

Drug(s) suspected as cause:
Myfortic

Other drugs received by patient: Prograf; Omeprazole; Calcium; Levothyroxine Sodium; Acyclovir; Prednisone TAB; Cephalexin; Fluoxetine HCL



Possible Myfortic side effects in male

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

Patient: male

Reactions: Joint Swelling, Gout, Abasia, Diverticulitis, Gingival Infection, Urine Abnormality, Tooth Infection, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

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

Patient: male

Reactions: Dysarthria, Psychomotor Skills Impaired, Circulatory Collapse, Cerebrovascular Accident, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in female

Reported by a physician from Korea, Republic of on 2012-08-17

Patient: female, weighing 48.2 kg (106.0 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Myfortic
    Dosage: 540 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-10

Neoral
    Dosage: 162.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-07

NO Treatment Received
    Dosage: no treatment received
    Indication: Renal Transplant

Other drugs received by patient: Synthroid; Norvasc; Unasyn; Methylprednisolone; Humulin R; Mucopect; Sucralfate; Ranitidine Hydrochloride



Possible Myfortic side effects in male

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

Patient: male

Reactions: Fall

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

Reported by a physician from Brazil on 2012-08-15

Patient: male, weighing 73.6 kg (161.9 pounds)

Reactions: Exophthalmos, Obstruction, Parophthalmia, Kidney Transplant Rejection, Hypercalcaemia, Eye Pain, Renal Impairment, Sinus Headache, Sepsis, Sinusitis, Pyelocaliectasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Aeb071
    Dosage: code not broken
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-06
    End date: 2010-12-23

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-06
    End date: 2010-12-23

Mycophenolic Acid
    Dosage: code not broken
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-06
    End date: 2010-12-23

Myfortic
    Dosage: 720 mg daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-24

Prednisone TAB
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2010-12-06

Prednisone TAB
    Dosage: 10 mg, daily
    Administration route: Oral

Prograf
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2010-12-06

Prograf
    Dosage: 3 mg, unk
    Start date: 2011-06-13

Other drugs received by patient: Fluconazole



Possible Myfortic side effects in 51 year old female

Reported by a physician from Belgium on 2012-08-14

Patient: 51 year old female

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Everolimus
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2011-09-13
    End date: 2011-09-22

Everolimus
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-13
    End date: 2011-09-22

Myfortic
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-07

Myfortic
    Dosage: 1800 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-10
    End date: 2011-09-12

Neoral
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-08-16
    End date: 2011-09-05

Neoral
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-22

Other drugs received by patient: Medrol; Medrol



Possible Myfortic side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-14

Patient: male

Reactions: Abdominal Discomfort, Gastrointestinal Motility Disorder, Nausea, Dyspepsia, Depression, Memory Impairment, Gastrointestinal Injury

Drug(s) suspected as cause:
Cyclosporine
    Dosage: unk ukn, unk

Myfortic

Other drugs received by patient: Prednisone TAB



Possible Myfortic side effects in male

Reported by a physician from Germany on 2012-08-13

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 540 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-25

Prednisolone
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2012-07-26

Prednisolone
    Dosage: 500 mg, unk
    Indication: Renal Transplant
    Start date: 2012-07-25

Prograf
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-24

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant
    Start date: 2012-07-25

Other drugs received by patient: Pantoprazole; Norvasc; Pravastatin; Nebivolol



Possible Myfortic side effects in female

Reported by a pharmacist from United Kingdom on 2012-08-13

Patient: female

Reactions: Brain Injury, Oral Administration Complication, Mastication Disorder, Cerebrovascular Accident

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-13

Patient: male

Reactions: Abdominal Discomfort, Gastrointestinal Motility Disorder, Nausea, Dyspepsia, Memory Impairment, Depression, Gastrointestinal Injury

Drug(s) suspected as cause:
Cyclosporine
    Dosage: unk ukn, unk

Myfortic

Other drugs received by patient: Prednisone TAB



Possible Myfortic side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female

Reactions: Vascular Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient:

Reactions: Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Myfortic

Other drugs received by patient: Prograf; Prednisone TAB



Possible Myfortic side effects in male

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

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Sepsis, Bundle Branch Block Left, Pyrexia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Belatacept
    Dosage: 435 mg, one month
    Indication: Renal Transplant
    Start date: 2006-08-02

Myfortic
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-14

Prednisone TAB
    Dosage: 5 mg, qd
    Indication: Renal Transplant
    Start date: 2010-09-16

Other drugs received by patient: Crestor



Possible Myfortic side effects in male

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

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Sepsis, Bundle Branch Block Left, Pyrexia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Belatacept
    Dosage: 435 mg, one month
    Indication: Renal Transplant
    Start date: 2006-08-02

Myfortic
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-14

Prednisone TAB
    Dosage: 5 mg, qd
    Indication: Renal Transplant
    Start date: 2010-09-16

Other drugs received by patient: Crestor



Possible Myfortic side effects in 33 year old female

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

Patient: 33 year old female

Reactions: Depression

Drug(s) suspected as cause:
Myfortic

Other drugs received by patient: Prograf; Prednisone TAB



Possible Myfortic side effects in male

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

Patient: male, weighing 76.6 kg (168.5 pounds)

Reactions: Atrial Fibrillation, Kidney Transplant Rejection, Wound Infection Staphylococcal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 360 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-18
    End date: 2012-05-02

Myfortic
    Dosage: 360 mg, bid
    Administration route: Oral

Prednisone
    Dosage: 15 mg, qd
    Administration route: Oral

Prednisone
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-19
    End date: 2012-05-02

Prograf
    Dosage: 1.5-0-2.0mg
    Administration route: Oral

Prograf
    Dosage: 1.5-0-1mg
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-18
    End date: 2012-04-27

Thymoglobulin
    Dosage: 75 mg, qd
    Start date: 2012-05-18

Other drugs received by patient: Simulect



Possible Myfortic side effects in male

Reported by a physician from Netherlands on 2012-08-07

Patient: male

Reactions: Type 2 Diabetes Mellitus, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 360 mg, bid
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-03-01

Prednisone TAB
    Dosage: 10 mg, unk
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-07-09

Prograf
    Dosage: 3 mg, bid
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-07-09

Other drugs received by patient: Tolbutamide



Possible Myfortic side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female

Reactions: Basal Cell Carcinoma, Bowen's Disease

Drug(s) suspected as cause:
Belatacept
    Dosage: 275 mg, unk
    Indication: Renal Transplant
    Start date: 2007-01-15

Myfortic
    Dosage: 500 mg, bid
    Indication: Renal Transplant
    Start date: 2011-04-08

Prednisone
    Dosage: 5 mg, qd
    Indication: Renal Transplant
    Start date: 2011-08-22



Possible Myfortic side effects in 15 year old female

Reported by a physician from Kenya on 2012-08-07

Patient: 15 year old female

Reactions: Dialysis, Diarrhoea, Renal Tubular Necrosis, Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic

Other drugs received by patient: Tacrolimus; Prednisolone; Amlodipine



Possible Myfortic side effects in male

Reported by a physician from United States on 2012-08-05

Patient: male

Reactions: Renal Failure

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-05

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Myfortic



Possible Myfortic side effects in male

Reported by a physician from Netherlands on 2012-08-03

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Hydronephrosis, Orthostatic Hypertension, Escherichia Urinary Tract Infection, Ureteric Stenosis, Oedema Peripheral, Hypertension, Thrombocytopenia, Leukopenia, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Myfortic
    Dosage: 360 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-13
    End date: 2012-02-11

Myfortic
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-22
    End date: 2012-05-02

Neoral
    Dosage: 175 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-08-05
    End date: 2012-02-11

Neoral
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-22
    End date: 2012-05-02

Neoral
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Prednisolone
    Dosage: unk
    Start date: 2012-02-22
    End date: 2012-05-02

Prednisolone
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-13
    End date: 2012-02-11

Prednisolone
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Other drugs received by patient: Lasix; Amlodipine; Calcium; Lipitor; Enalapril Maleate; Lisinopril; Mono-Cedocard; Valcyte; Calcium Carbonate; Nexium; Mono-Cedocard; Etalpha



Possible Myfortic side effects in male

Reported by a physician from Netherlands on 2012-08-02

Patient: male

Reactions: Diabetes Mellitus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 360 mg, bid
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-03-01

Prednisone TAB
    Dosage: 10 mg, unk
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-07-09

Prograf
    Dosage: 3 mg, bid
    Indication: Renal Transplant
    Start date: 2011-07-14
    End date: 2012-07-09

Other drugs received by patient: Tolbutamide



Possible Myfortic side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male

Reactions: Rotator Cuff Syndrome, Cerebrovascular Accident, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 360 mg, bid
    Administration route: Oral

Myfortic
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-29

Other drugs received by patient: Amlodipine; Calcium Carbonate; Silver; Tylenol (Caplet); Ambien; Toprol-XL; DCN-WO; Centrum; Plavix; Prednisone; Prilosec; Flexeril; Ultram; Prograf; Aspirin; Ketoconazole; Crestor

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