This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prograf (Tacrolimus) 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 (1901)
Death (541)
Life Threatening Events (95)
Disability (67)
Reports by Reaction Type
Drug Ineffective (350),
Death (209),
Acute Graft Versus Host Disease (183),
Off Label Use (177),
Diarrhoea (75),
Pneumonia (71),
Chronic Graft Versus Host Disease (70),
Hospitalisation (69),
Treatment Noncompliance (65),
Renal Failure Acute (65),
Renal Transplant (62),
Kidney Transplant Rejection (60)
Below are a few examples of reports where side effects / adverse reactions may be related to Prograf (Tacrolimus). For a complete list or a specific selection of reports, please use the links above.
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 63.0 kg (138.6 pounds)
Reactions: Off Label Use, Dialysis
Drug(s) suspected as cause:
Prograf
Indication: Pancreas Transplant
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2003-12-08
Other drugs received by patient: Sodium Bicarbonate; Amlodipine; Rapamune; Atenolol; Calcitriol; Promethazine; Oxycodone HCL
Possible Prograf side effects in 66 year old male
Reported by a physician from Japan on 2012-08-27
Patient: 66 year old male
Reactions: Graft Versus Host Disease in Skin, Drug Ineffective
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Mycophenolate Mefetil; Fludarabine Phosphate; Busulfan; ATG / 00575401 /
Possible Prograf side effects in 62 year old male
Reported by a physician from Japan on 2012-08-27
Patient: 62 year old male
Reactions: Colon Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Corticosteroid NOS
Possible Prograf side effects in 11 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 11 year old male
Reactions: Osmotic Demyelination Syndrome, Demyelination
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Blood and Related Products; Factor VII; Mycophenolate Mefetil; Unspecified Vasopressors; Unspecified Steroid; Sodium Chloride
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Liver Transplant
Drug(s) suspected as cause:
Prograf
Indication: Liver Transplant
Prograf
Dosage: 3 mg, uid/qd
Administration route: Oral
Indication: Renal Transplant
Other drugs received by patient: Diovan; Epivir; Myfortic; Janumet
Possible Prograf side effects in male
Reported by a physician from Japan on 2012-08-27
Patient: male
Reactions: Drug Ineffective, Graft Versus Host Disease in Liver
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Busulfan; Fludarabine Phosphate; Methotrexate
Possible Prograf 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 Prograf side effects in female
Reported by a physician from Japan on 2012-08-27
Patient: female, weighing 39.7 kg (87.3 pounds)
Reactions: Scleroderma Renal Crisis, Posterior Reversible Encephalopathy Syndrome, Thrombotic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Prednisolone
Dosage: 50 mg, unknown/d
Administration route: Oral
Indication: Dermatomyositis
Prednisolone
Dosage: 13.75 mg, bid
Administration route: Oral
Start date: 2010-03-31
Prograf
Indication: Scleroderma
Prograf
Dosage: 2.5 mg, uid/qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-01-25
End date: 2011-03-23
Other drugs received by patient: Amlodipine; Hirudoid; Procylin; Bonoteo; Itraconazole; Amlodipine; Omeprazole; Mobic; Pursennid; Antebate
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Hepatic Failure, Hepatic Cirrhosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Dosage: 2 mg in am/1 mg in pm
Administration route: Oral
Indication: Liver Transplant
Start date: 2002-10-11
Prograf
Dosage: 1 mg, bid
Administration route: Oral
Start date: 2009-01-01
End date: 2012-08-16
Other drugs received by patient: Aldactone; Doxepin
Possible Prograf side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Coronary Artery Disease, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Atenolol; Multi-Vitamins; Tylenol W / Codeine NO. 3; Prilosec; Tums / 07357001 /; Colace; Colecalciferol; Rapamune; Hydralazine HCL; Lasix; Crestor; Cardizem
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Death, Off Label Use
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Renal Transplant
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 72.0 kg (158.4 pounds)
Reactions: Femur Fracture, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: MG-Plus-Protein; Rapamune; Paroxetine; Cellcept; Ursodiol
Possible Prograf side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Off Label Use, Abdominal Pain, Myasthenia Gravis, Pneumonia Aspiration, Treatment Noncompliance, Gastrointestinal Tube Insertion, Influenza
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Prednisone TAB
Dosage: 20 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: 30 mg, uid/qd
Prograf
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Myasthenia Gravis
Start date: 2010-07-28
Other drugs received by patient: Lisinopril; Tagamet; Lortab; Mestinon
Possible Prograf side effects in 11 year old male
Reported by a consumer/non-health professional from United States on 2012-08-26
Patient: 11 year old male, weighing 43.0 kg (94.6 pounds)
Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Pain in Extremity, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Administration route: Oral
Indication: Bone Marrow Transplant
Start date: 2012-07-25
End date: 2012-08-10
Tacrolimus
Administration route: Oral
Indication: Bone Marrow Transplant
Start date: 2012-05-01
End date: 2012-06-28
Tacrolimus
Administration route: Oral
Start date: 2012-08-13
Tacrolimus
Administration route: Oral
Start date: 2012-06-29
End date: 2012-07-24
Possible Prograf side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Road Traffic Accident, Malaise, Treatment Noncompliance
Drug(s) suspected as cause:
Align
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prograf
Dosage: 5 mg in the morning and 6 in the evening
Administration route: Oral
Indication: Renal Transplant
Start date: 2009-06-25
Possible Prograf side effects in male
Reported by a physician from Japan on 2012-08-24
Patient: male, weighing 13.0 kg (28.6 pounds)
Reactions: Post Transplant Lymphoproliferative Disorder, Abdominal Pain, Intestinal Perforation, Kidney Transplant Rejection, Blood Creatine Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Medrol
Dosage: 20 to 4 mg daily, unk
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-11-24
Mycophenolate Mofetil (Cellcept)
Dosage: 250 mg, unk
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-11-23
End date: 2011-05-09
Prograf
Dosage: 0.6 mg, unk
Indication: Renal Transplant
Start date: 2010-11-24
Prograf
Dosage: 11.6 mg, unk
Administration route: Oral
Start date: 2010-12-03
Simulect
Dosage: 10 mg, unk
Start date: 2010-11-28
End date: 2010-11-28
Simulect
Dosage: 10 mg, unk
Start date: 2010-11-24
End date: 2010-11-24
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Heart Transplant, Renal Transplant
Drug(s) suspected as cause:
Prograf
Dosage: 10 mg, uid/qd
Administration route: Oral
Indication: Renal Transplant
Prograf
Indication: Heart Transplant
Possible Prograf side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Renal Failure, Drug Ineffective, Kidney Transplant Rejection
Drug(s) suspected as cause:
Prograf
Dosage: 9 mg, bid
Administration route: Oral
Start date: 2012-05-01
Prograf
Dosage: 4 mg bid and 10 mg daily
Administration route: Oral
Indication: Renal Transplant
Start date: 2003-08-01
Possible Prograf side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female, weighing 50.6 kg (111.3 pounds)
Reactions: Urinary Tract Infection, Rhinorrhoea, Cytomegalovirus Viraemia, Pyrexia, Renal Failure, Diarrhoea, Urosepsis, Neutropenia, Sinusitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Indication: Prophylaxis
Mycophenolate Mefetil
Dosage: unk mg, bid
Administration route: Oral
Start date: 2011-06-09
Mycophenolate Mefetil
Dosage: 1000 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-08-24
End date: 2011-06-04
Prednisone TAB
Dosage: 5 mg, qd
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-10-23
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2011-05-24
End date: 2011-06-04
Other drugs received by patient: Losartan Potassium; Lasix
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male, weighing 63.0 kg (138.6 pounds)
Reactions: Fluid Overload, Hyperparathyroidism Secondary, Complications of Transplanted Kidney, Hyperkalaemia, Phosphorus Metabolism Disorder, Hypokalaemia, Off Label Use, Anaemia of Chronic Disease, Iron Deficiency Anaemia, Renal Graft Loss
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2002-01-05
Prograf
Dosage: 2.5 mg, bid
Administration route: Oral
Indication: Pancreas Transplant
Start date: 2012-06-20
Other drugs received by patient: Bactrim; Caltrate Plus Iron and Vitamin D; Prednisone TAB; Zetia; Pravastatin; Vitamin D; Imodium; Tums / 00193601 /; Prevacid; Calcitrol / 00508501 /; Colace; Rapamune; Nephrocaps / 01801401 /
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male, weighing 86.0 kg (189.2 pounds)
Reactions: Vomiting, Food Poisoning
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Lantus
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Drug Ineffective, Coagulopathy, Haemorrhagic Anaemia, Toxicity To Various Agents, Kidney Transplant Rejection, Catheter Site Haemorrhage, Haematochezia, Aortic Valve Replacement, Hypertension, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dosage: unk
Indication: Aortic Valve Replacement
Prograf
Dosage: 4 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2007-12-25
Possible Prograf side effects in female
Reported by a physician from France on 2012-08-22
Patient: female
Reactions: Diabetic Complication, Impaired Gastric Emptying
Drug(s) suspected as cause:
Prograf
Dosage: 6.5 mg, unknown/d
End date: 2011-08-28
Prograf
Dosage: unk mg, unknown/d
Indication: Renal Transplant
Start date: 2004-06-01
Possible Prograf side effects in female
Reported by a physician from United States on 2012-08-22
Patient: female, weighing 99.0 kg (217.8 pounds)
Reactions: Small Intestinal Obstruction, Oesophageal Ulcer, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded Asp8597
Dosage: 800 unk, total dose
Indication: Renal Transplant
Start date: 2012-06-19
End date: 2012-06-19
Mycophenolate Mefetil
Dosage: 500 unk, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2012-06-19
End date: 2012-07-02
Prograf
Dosage: 3 mg, bid
Administration route: Oral
Start date: 2012-07-06
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2012-06-21
Other drugs received by patient: Beta Blocking Agents
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male, weighing 52.0 kg (114.4 pounds)
Reactions: Death, Off Label Use
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in 79 year old female
Reported by a physician from Japan on 2012-08-22
Patient: 79 year old female
Reactions: Interstitial Lung Disease, Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Enbrel
Dosage: 25 mg, 1x/day
Indication: Rheumatoid Arthritis
Start date: 2006-06-15
End date: 2012-03-27
Enbrel
Dosage: 50 mg, 1x/day
Start date: 2012-03-28
End date: 2012-05-01
Prograf
Dosage: 1 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Rheumatrex
Dosage: 6 mg (2 mg x 3 times) , weekly
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Isoniazid; Prednisolone; Rebamipide; Folic Acid; Pydoxal
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Cellcept
Possible Prograf side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Fungal Abscess Central Nervous System, Diabetes Mellitus, Mental Status Changes, Fatigue, Hypocalcaemia, Decreased Appetite, Vomiting, Nausea, Hyperglycaemia, Urinary Tract Infection, Convulsion, Lower Respiratory Tract Infection Fungal, Respiratory Failure, Diarrhoea, Dehydration, Hypophagia, Sepsis, Hyperosmolar State, Diabetic Ketoacidosis, Septic Shock, Asthenia
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Certican
Dosage: 0.75 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-11-21
End date: 2011-01-11
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-11-21
Other drugs received by patient: Prednisone; Prednisone; Insulin; Prednisone
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female, weighing 76.0 kg (167.2 pounds)
Reactions: Intestinal Haemorrhage, Off Label Use, Death, Pneumonia, Clostridium Test Positive, Cardiac Failure Congestive
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 0.5 mg, bid
Administration route: Oral
Start date: 2008-10-04
Prograf
Dosage: 1.5 mg, uid/qd
Administration route: Oral
Indication: Lung Transplant
Start date: 2008-10-02
Other drugs received by patient: Lisinopril; Lopid; Metoprolol Tartrate; Mirtazapine; Lantus; Pravastatin; Mycelex; Novolog; Protonix; Prednisone
|
