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Prograf (Tacrolimus) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (177)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prograf (Tacrolimus) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 177   Next >>

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 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, 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 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 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 2012-08-22

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 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



Possible Prograf side effects in male

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

Patient: male

Reactions: Off Label Use, Bone Marrow Transplant, Transplant

Drug(s) suspected as cause:
Prograf
    Dosage: 5 mg, uid/qd
    Administration route: Oral
    Indication: Stem Cell Transplant

Prograf
    Indication: Bone Marrow Transplant



Possible Prograf side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female

Reactions: Off Label Use, Renal Transplant

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in male

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

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Off Label Use, Dialysis, Renal Transplant, Post Procedural Complication, Laceration, Rotator Cuff Syndrome, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Indication: Pancreas Transplant

Prograf
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2005-08-01

Other drugs received by patient: Cellcept; Aspirin; Lantus; Novolog; Nexium; Cellcept; Cozaar



Possible Prograf side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female

Reactions: Off Label Use, Graft Versus Host Disease

Drug(s) suspected as cause:
Prograf

Other drugs received by patient: Prednisone TAB; Cellcept



Possible Prograf side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-08-14

Patient: 45 year old male

Reactions: Bronchopulmonary Aspergillosis, Graft Versus Host Disease, Disseminated Intravascular Coagulation, Toxicity To Various Agents, Gastric Ulcer, Pneumocystis Jiroveci Pneumonia, Off Label Use, Respiratory Failure, Thrombocytopenia, Leukopenia, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf

Other drugs received by patient: Imuran; Medrol



Possible Prograf side effects in female

Reported by a pharmacist from Japan on 2012-08-14

Patient: female

Reactions: Off Label Use, Renal Disorder, Dehydration

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in female

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

Patient: female

Reactions: Off Label Use, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf

Other drugs received by patient: Lipitor; Lisinopril; Gabapentin; Cellcept; Norvasc



Possible Prograf side effects in male

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

Patient: male, weighing 114.0 kg (250.8 pounds)

Reactions: Graft Versus Host Disease, Hyperkalaemia, Blood Magnesium Decreased, Obliterative Bronchiolitis, Mycobacterium Avium Complex Infection, Off Label Use, Fatigue, Dyspnoea Exertional, Oedema Peripheral, Hypoxia, Pneumonia Staphylococcal, Acute Respiratory Failure, Cough, Fluid Retention, Muscular Weakness, Respiratory Distress, Tremor, Renal Failure, Sepsis, Alopecia, Hypertension

Drug(s) suspected as cause:
Prograf
    Indication: Graft Versus Host Disease

Prograf
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Stem Cell Transplant
    Start date: 2008-10-29

Other drugs received by patient: Lactaid; Colace; Entocort EC; Dapsone; Tamsulosin HCL; Zovirax / 00587301 /; Noxafil; Reglan; Norvasc



Possible Prograf side effects in male

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

Patient: male, weighing 81.0 kg (178.2 pounds)

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf

Other drugs received by patient: Calcium Carbonate; Imuran; Acyclovir; Prednisone TAB; Zyrtec



Possible Prograf side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: Off Label Use, Pancreas Transplant

Drug(s) suspected as cause:
Prograf
    Indication: Pancreas Transplant

Prograf
    Dosage: 3 mg, bid
    Administration route: Oral
    Indication: Renal Transplant

Other drugs received by patient: Cellcept



Possible Prograf side effects in female

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

Patient: female

Reactions: Multi-Organ Failure, 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 2012-08-13

Patient: male

Reactions: Off Label Use, Death, Pulmonary Thrombosis, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Off Label Use, Renal Transplant, Post Procedural Complication, Rotator Cuff Syndrome, Laceration, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Indication: Pancreas Transplant

Prograf
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2005-08-01

Other drugs received by patient: Nexium; Lantus; Novolog; Cellcept; Cellcept; Cozaar; Aspirin



Possible Prograf side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female, weighing 64.4 kg (141.7 pounds)

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female, weighing 88.0 kg (193.6 pounds)

Reactions: Off Label Use, Confusional State, Laboratory Test Abnormal, Pyrexia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Dosage: 2.5 mg, bid
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-01

Prograf
    Indication: Stem Cell Transplant

Prograf
    Indication: Bone Marrow Transplant



Possible Prograf side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Death, Off Label Use, Renal Transplant

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf
    Dosage: 2 mg in am, 1 mg in pm
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2004-05-11

Prograf
    Indication: Pancreas Transplant



Possible Prograf side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Weight Decreased, Pneumonia, Malnutrition, Lung Transplant Rejection, Treatment Noncompliance, Off Label Use, Major Depression, Acute Respiratory Failure, Hypogammaglobulinaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prograf
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Start date: 2011-12-29
    End date: 2011-12-31

Prograf
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Indication: Lung Transplant
    Start date: 2008-03-19
    End date: 2011-12-20

Prograf
    Dosage: 1 mg, bid
    Administration route: Oral
    Start date: 2011-12-26
    End date: 2011-12-29

Other drugs received by patient: Calcite; Cell Cept; Zithromax; Spiriva; Prednisone; Symbicort; Magnesium Oxide; Celexa; Fosamax; Aburend; Vuoned; Tylenol (Caplet); Spiriva; Metoprolol Tartrate



Possible Prograf side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female

Reactions: Off Label Use, Graft Versus Host Disease

Drug(s) suspected as cause:
Prograf



Possible Prograf side effects in

Reported by a physician from United States on 2012-07-30

Patient:

Reactions: Off Label Use, Hospitalisation, Treatment Noncompliance, Gastrointestinal Tube Insertion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Dosage: 5 mg, uid/qd
    Administration route: Oral
    Indication: Myasthenia Gravis
    Start date: 2008-07-01
    End date: 2010-06-01

Prograf
    Dosage: 5 mg, uid/qd
    Administration route: Oral



Possible Prograf side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

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 physician from France on 2012-07-27

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Weight Decreased, Hyperkalaemia, Diabetes Mellitus, Off Label Use, Renal Failure, Fatigue, Visual Impairment, Dehydration, Hyperosmolar State, Diabetic Hyperosmolar Coma

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Prograf
    Dosage: 3.5 mg, bid
    Administration route: Oral
    Indication: Nephrotic Syndrome
    Start date: 2011-10-30
    End date: 2011-12-30

Prograf
    Dosage: 3 mg, bid
    Administration route: Oral
    Start date: 2011-12-31
    End date: 2012-01-16

Other drugs received by patient: Irbesartan; Prednisone TAB; Prednisone TAB; Allopurinol; Ezetimibe; Perindopril Erbumine



Possible Prograf side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male

Reactions: Abdominal Pain, Off Label Use, Pneumonia Aspiration, Myasthenia Gravis, 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

Other drugs received by patient: Tagamet; Mestinon; Lortab; Lisinopril



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