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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 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 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 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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