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Prograf (Tacrolimus) - Side Effect Reports to FDA

 
 



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 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 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 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 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

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 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 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 2012-08-22

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 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 physician from Japan on 2012-08-21

Patient: male

Reactions: Pneumonia Aspiration, Gastrointestinal Hypermotility, Hyperkalaemia, Eye Discharge, Urine Output Decreased, Hypotension, Dyskinesia, Hyponatraemia, Cytomegalovirus Viraemia, Diarrhoea, Bronchitis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-09-20
    End date: 2010-10-10

Mycophenolate Mofetil (Cellcept)
    Dosage: 250 mg, unk
    Administration route: Oral
    Start date: 2010-11-15
    End date: 2010-11-26

Mycophenolate Mofetil (Cellcept)
    Dosage: 250 mg, unk
    Administration route: Oral
    Start date: 2010-10-12
    End date: 2010-11-09

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2010-11-26
    End date: 2011-01-29

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2010-11-10
    End date: 2010-11-14

Prednisolone
    Dosage: 17.5 mg, unk
    Start date: 2010-09-18

Prednisolone
    Dosage: 12.5 mg, unk
    Start date: 2010-09-20

Prednisolone
    Dosage: 10 mg, unk
    Indication: Renal Transplant
    Start date: 2010-09-15

Prednisolone
    Dosage: 20 mg, unk
    Start date: 2010-09-16

Prednisolone
    Dosage: 15 mg, unk
    Start date: 2010-09-19

Prednisolone
    Dosage: 10 mg, unk
    Start date: 2010-09-21

Prograf
    Dosage: 0.5 mg, unk
    Indication: Renal Transplant
    Start date: 2010-09-15

Prograf
    Dosage: 2.8 mg, unk
    Administration route: Oral
    Start date: 2010-10-18
    End date: 2010-10-27

Prograf
    Dosage: 2.4 mg, unk
    Administration route: Oral
    Start date: 2010-11-02
    End date: 2010-11-04

Prograf
    Dosage: 0.3 mg, unk
    Start date: 2010-09-15

Prograf
    Dosage: 0.25 mg, unk
    Start date: 2010-09-22

Prograf
    Dosage: 2.8 mg, unk
    Administration route: Oral
    Start date: 2010-11-05
    End date: 2010-11-08

Prograf
    Dosage: 2.2 mg, unk
    Administration route: Oral
    Start date: 2010-10-28
    End date: 2010-11-01

Prograf
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2010-09-29
    End date: 2010-10-12

Prograf
    Dosage: 2.4 mg, unk
    Administration route: Oral
    Start date: 2010-11-09
    End date: 2010-11-10

Prograf
    Dosage: 3.6 mg, unk
    Administration route: Oral
    Start date: 2010-10-13
    End date: 2010-10-17

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-09-22

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-09-15

Other drugs received by patient: Omeprazole; Prednisolone; Prednisolone; Neoral; Risperdal; Midazolam HCL; Futhan; Cefazolin; Clostridium Butyricum; Clostridium Butyricum; Clostridium Butyricum; Florinef; Aspirin; Prednisolone; Neoral; Neoral; Cefazolin; Depakene; Depakene; Prednisolone; Prednisolone; Prednisolone; Neoral; Neoral; Cefazolin; Clostridium Butyricum; Dantrium; Dantrium; Dantrium; Tannalbin; Fentanyl; Depakene; Lansoprazole; Prednisolone; Dantrium; Midazolam HCL; Rocuronium Bromide; Prednisolone; Lioresal; Levothyroxine Sodium; Levothyroxine Sodium; Precedex; Levothyroxine Sodium; Clostridium Butyricum



Possible Prograf side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 51 year old female

Reactions: Nausea, Diarrhoea, Clostridium Difficile Colitis, Microangiopathic Haemolytic Anaemia, Muscular Weakness, Renal Failure Acute, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: unk
    Start date: 2012-05-01

Campath
    Dosage: 100 mg, unknown/d
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Fludarabine Phosphate
    Dosage: 355 mg, total dose
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Fludarabine Phosphate
    Dosage: unk
    Start date: 2012-05-01

Melphalan Hydrochloride
    Dosage: 333 mg, total dose
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Melphalan Hydrochloride
    Dosage: unk
    Start date: 2012-05-02

Prograf
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Sprycel
    Dosage: unk
    Administration route: Oral
    Start date: 2012-04-26

Sprycel
    Dosage: unk
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

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