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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