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Index of reports
> Cases with Treatment Noncompliance (65)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prograf (Tacrolimus) where reactions include treatment noncompliance. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 65 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
Prograf
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Myasthenia Gravis
Start date: 2010-07-28
Prednisone TAB
Dosage: 30 mg, uid/qd
Other drugs received by patient: Lisinopril; Tagamet; Lortab; Mestinon
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:
Prograf
Dosage: 5 mg in the morning and 6 in the evening
Administration route: Oral
Indication: Renal Transplant
Start date: 2009-06-25
Align
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: male, weighing 99.0 kg (217.8 pounds)
Reactions: Rectal Polyp, Diabetes Mellitus, Hypoglycaemia, Visual Acuity Reduced, Kidney Transplant Rejection, Treatment Noncompliance, Malignant Hypertension, Arthropathy, Hyperparathyroidism, Renal Graft Loss, Spinal Laminectomy, Thrombocytopenia, Back Pain, Benign Prostatic Hyperplasia, Carotid Bruit, Hypervolaemia, Hyperlipidaemia, Renal Failure, Diarrhoea, Anaemia of Chronic Disease, BK Virus Infection, Hypertension, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 5 mg, q12 hours
Administration route: Oral
Prograf
Dosage: 4 mg, q12 hours
Administration route: Oral
Prograf
Dosage: 6 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-03-12
Prograf
Dosage: 1 mg, uid/qd
Administration route: Oral
Antithymocyte Immunoglobulin (Rabbit)
Dosage: 75 mg, unknown/d
Indication: Kidney Transplant Rejection
Protein Pump Inhibitor
Dosage: unk
Indication: Product Used FOR Unknown Indication
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
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 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:
Prograf
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Myasthenia Gravis
Prednisone TAB
Dosage: 20 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: 30 mg, uid/qd
Other drugs received by patient: Tagamet; Mestinon; Lortab; Lisinopril
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13
Patient: male, weighing 99.0 kg (217.8 pounds)
Reactions: Rectal Polyp, Diabetes Mellitus, Hypoglycaemia, Visual Acuity Reduced, Kidney Transplant Rejection, Treatment Noncompliance, Malignant Hypertension, Arthropathy, Hyperparathyroidism, Spinal Laminectomy, Thrombocytopenia, Back Pain, Benign Prostatic Hyperplasia, Carotid Bruit, Hypervolaemia, Hyperlipidaemia, Renal Failure, Diarrhoea, Anaemia of Chronic Disease, BK Virus Infection, Hypertension, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 5 mg, q12 hours
Administration route: Oral
Prograf
Dosage: 6 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-03-12
Prograf
Dosage: 1 mg, uid/qd
Administration route: Oral
Protein Pump Inhibitor
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prograf
Dosage: 4 mg, q12 hours
Administration route: Oral
Anti-Thymocyte Globulin Rabbit NOS
Dosage: 75 mg, unknown/d
Indication: Kidney Transplant Rejection
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male
Reactions: Off Label Use, Weight Increased, Drug Ineffective FOR Unapproved Indication, Chest Pain, Oedema, Treatment Noncompliance, Nephrotic Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: unk
Start date: 2010-09-14
Prograf
Dosage: 3.5 mg, bid
Administration route: Oral
Indication: Nephrotic Syndrome
Other drugs received by patient: Lasix; Miralax / 00754501 /; Lansoprazole; Prednisone; Labetalol HCL; Norvasc
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
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
Other drugs received by patient: Metoprolol Tartrate; Calcite; Magnesium Oxide; Vuoned; Spiriva; Zithromax; Cellcept; Fosamax; Spiriva; Acetaminophen; Symbicort; Celexa; Prednisone TAB; Aburend
Possible Prograf side effects in male
Reported by a physician from United States on 2012-06-25
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Cellcept
Possible Prograf side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Pancreas Transplant, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: male, weighing 99.0 kg (217.8 pounds)
Reactions: Rectal Polyp, Diabetes Mellitus, Hypoglycaemia, Visual Acuity Reduced, Kidney Transplant Rejection, Treatment Noncompliance, Arthropathy, Hyperparathyroidism, Spinal Laminectomy, Thrombocytopenia, Back Pain, Benign Prostatic Hyperplasia, Carotid Bruit, Hypervolaemia, Renal Failure, Diarrhoea, Anaemia of Chronic Disease, BK Virus Infection, Hypertension, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 1 mg, uid/qd
Administration route: Oral
Prograf
Dosage: 4 mg, q12 hours
Administration route: Oral
Anti-Thymocyte Globulin Rabbit NOS
Dosage: 75 mg, unknown/d
Indication: Kidney Transplant Rejection
Protein Pump Inhibitor
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prograf
Dosage: 6 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-03-12
Prograf
Dosage: 5 mg, q12 hours
Administration route: Oral
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: male, weighing 99.0 kg (217.8 pounds)
Reactions: Diabetes Mellitus, Hypervolaemia, Kidney Transplant Rejection, Treatment Noncompliance, Diarrhoea, Anaemia of Chronic Disease, Hypertension, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 1 mg, uid/qd
Administration route: Oral
Prograf
Dosage: 6 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-03-12
Protein Pump Inhibitor
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prograf
Dosage: 5 mg, q12 hours
Administration route: Oral
Anti-Thymocyte Globulin Rabbit NOS
Dosage: 75 mg, unknown/d
Indication: Kidney Transplant Rejection
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-09
Patient: male, weighing 99.0 kg (217.8 pounds)
Reactions: Diabetes Mellitus, Diarrhoea, Anaemia of Chronic Disease, Kidney Transplant Rejection, Treatment Noncompliance, Hypertension, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Protein Pump Inhibitor
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prograf
Dosage: 5 mg, q12 hours
Administration route: Oral
Prograf
Dosage: 1 mg, uid/qd
Administration route: Oral
Prograf
Dosage: 6 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2010-03-12
Anti-Thymocyte Globulin Rabbit NOS
Dosage: 75 mg, unknown/d
Indication: Kidney Transplant Rejection
Possible Prograf side effects in female
Reported by a physician from United States on 2012-05-02
Patient: female, weighing 99.0 kg (217.8 pounds)
Reactions: Abdominal Pain, Contusion, Pruritus, Tachycardia, Headache, Blood Product Transfusion Dependent, Pyrexia, Personality Disorder, Appetite Disorder, Treatment Noncompliance, Transaminases Increased, Vaginal Haemorrhage, Malaise, Oedema Peripheral, Epistaxis, Cough, Haematoma, Back Pain, Right Ventricular Failure, Malnutrition, Maternal Exposure During Pregnancy, Pancytopenia, Convulsion, Affective Disorder, Bacteraemia, BK Virus Infection, Sinusitis Fungal, Neutropenia, Chills, Fatigue, Fibromyalgia, Dizziness, Tachypnoea, Abortion Induced, Electrolyte Imbalance, Renal Failure Acute, Decreased Appetite, Vomiting, Dyspnoea, Nausea, Acute Myeloid Leukaemia, Rash, Anxiety, Diarrhoea, Dysuria, Hypertension, Immobile, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in male
Reported by a physician from United States on 2012-04-26
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Abdominal Operation, Cholestatic Liver Injury, Cardiac Murmur, Renal Disorder, Treatment Noncompliance, Hospitalisation, Liver Transplant Rejection, Inguinal Hernia Repair
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 3 mg, bid
Administration route: Oral
Indication: Liver Transplant
Start date: 1995-08-11
End date: 2011-01-01
Prograf
Dosage: 3 mg, bid
Start date: 2012-04-03
Other drugs received by patient: Calcium; Multi-Vitamin
Possible Prograf side effects in female
Reported by a physician from United States on 2012-04-19
Patient: female, weighing 99.0 kg (217.8 pounds)
Reactions: Pruritus, Tachycardia, Blood Product Transfusion Dependent, Treatment Noncompliance, Fibromyalgia, Oedema Peripheral, Abortion Induced, Vomiting, Nausea, Maternal Exposure During Pregnancy, Acute Myeloid Leukaemia, Malnutrition, Pancytopenia, Convulsion, Dysuria, BK Virus Infection, Sinusitis Fungal, Neutropenia, Hypertension, Immobile, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Treatment Noncompliance, Lymphoproliferative Disorder, Foot Fracture, Heart Transplant Rejection, Gastrooesophageal Reflux Disease, Renal Failure Acute, Cough, Acute Prerenal Failure, Alcohol Withdrawal Syndrome, Gout, Delirium Tremens, Anaemia, Coronary Artery Stenosis, Vascular Graft Complication, Cataract Operation, Carotid Artery Stenosis, Cerebral Infarction, Gastric Polyps, Arthritis, Sleep Apnoea Syndrome, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 3 mg, bid
Administration route: Oral
Indication: Heart Transplant
Start date: 1993-02-11
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Prograf
Dosage: 0.5 mg, bid
Prograf
Dosage: 1.5 mg, bid
Administration route: Oral
Start date: 1993-02-11
Other drugs received by patient: Aspirin; Enalapril Maleate; Calcium Carbonate; Pravastatin; Diltiazem HCL; Losartan Potassium
Possible Prograf side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-17
Patient: male, weighing 115.0 kg (253.0 pounds)
Reactions: Confusional State, Abdominal Hernia, Hepatitis C, Abasia, Treatment Noncompliance, Generalised Oedema, Drug Level Above Therapeutic, Neuropathy Peripheral, Hepatic Encephalopathy, Peroneal Nerve Palsy, Oedema Peripheral, Liver Function Test Abnormal, Depression, Chronic Hepatitis, Blood Creatinine Increased, Hepatic Cirrhosis, Renal Failure Acute, Back Pain, Fluid Overload, Pneumonia, Hepatic Fibrosis, Blood Potassium Increased, Renal Failure Chronic, Tremor, Ocular Icterus, Liver Transplant Rejection, Ammonia Increased, Bronchitis, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 1 mg, bid
Administration route: Oral
Start date: 2012-03-14
Prograf
Dosage: 1 mg, bid
Administration route: Oral
Indication: Liver Transplant
Start date: 2006-02-13
End date: 2012-03-09
Codeine Sulfate
Dosage: unk
Indication: Pain
End date: 2012-03-13
Other drugs received by patient: Neurontin; Omeprazole
Possible Prograf side effects in male
Reported by a physician from United States on 2012-04-11
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Liver Transplant Rejection, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Multi-Vitamin
Possible Prograf side effects in female
Reported by a physician from United States on 2012-04-06
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Hepatic Failure, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: unk
Start date: 2011-09-30
Prograf
Dosage: unk
Indication: Liver Transplant
Start date: 2009-01-01
End date: 2011-08-01
Possible Prograf side effects in female
Reported by a physician from United States on 2012-04-05
Patient: female, weighing 99.0 kg (217.8 pounds)
Reactions: Pruritus, Tachycardia, Blood Product Transfusion Dependent, Treatment Noncompliance, Fibromyalgia, Oedema Peripheral, Abortion Induced, Vomiting, Nausea, Malnutrition, Maternal Exposure During Pregnancy, Acute Myeloid Leukaemia, Pancytopenia, Convulsion, BK Virus Infection, Dysuria, Sinusitis Fungal, Neutropenia, Hypertension, Immobile, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27
Patient: female
Reactions: Oesophageal Candidiasis, Abdominal Pain, Treatment Noncompliance, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-22
Patient: female, weighing 110.0 kg (242.0 pounds)
Reactions: Off Label Use, Multiple Organ Transplant Rejection, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 2 mg, bid
Administration route: Oral
Indication: Small Intestine Transplant
Start date: 2009-09-23
Prograf
Dosage: 4 mg in am, 3 mg in pm
Administration route: Oral
Indication: Pancreas Transplant
Other drugs received by patient: Ritalin; Keppra; Magnesium Sulfate; Hydrocortisone
Possible Prograf side effects in male
Reported by a physician from United States on 2012-03-22
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Eosinophilic Oesophagitis, Transplant Rejection, Liver Transplant Rejection, Small Intestine Transplant, Gastrooesophageal Reflux Disease, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Possible Prograf side effects in 57 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-09
Patient: 57 year old male
Reactions: Heart Transplant Rejection, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: unk
Indication: Heart Transplant
Tacrolimus
Dosage: unk
Indication: Heart Transplant
Other drugs received by patient: Lipitor; Calcium Carbonate; Vasotec; Diltiazem HCL; Prednisone; Celexa; Lantus; Nexium; Humalog; Neurontin; Aspirin; Mycophenolate Mofetil (Cellcept); Lasix; Synthroid
Possible Prograf side effects in
Reported by a physician from United States on 2012-03-06
Patient:
Reactions: Diabetes Mellitus, Lung Operation, Abdominal Discomfort, Malaise, Blood Pressure Inadequately Controlled, Pulmonary Oedema, Pneumothorax, Temperature Intolerance, Back Pain, Inadequate Analgesia, Post-Traumatic Stress Disorder, Diabetic Neuropathy, Back Injury, Pleural Adhesion, Blood Triglycerides Increased, Urine Flow Decreased, Urinary Hesitation, Fall, Blood Cholesterol Increased, Rotator Cuff Syndrome, Injury, Splenomegaly, Bipolar Disorder, Hepatitis A, Hepatitis B, Osteomyelitis, Deafness, Retinal Vein Occlusion, Treatment Noncompliance, Fracture, Proteinuria, Urinary Retention, Pneumonia, Pain in Extremity, Benign Prostatic Hyperplasia, Hypoaesthesia, Ankle Fracture, Osteonecrosis, Insomnia, Tendon Disorder, Portal Hypertension, Confusional State, Hepatic Function Abnormal, Drug Ineffective, Head Injury, Diabetic Nephropathy, Mania, Road Traffic Accident, Pleural Effusion, Gastrooesophageal Reflux Disease, Hepatic Fibrosis, Nausea, Incorrect Dose Administered, Varicella, Multiple Fractures, Renal Failure Chronic, Cerebrovascular Accident, Hyperlipidaemia, Diabetic Retinopathy, Pollakiuria, Microalbuminuria, Sexual Dysfunction, Hypertension, Arthritis, Infection Susceptibility Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 1 mg, bid
Administration route: Oral
Indication: Liver Transplant
Start date: 2003-07-05
Mycophenolate Mofetil (Cellcept)
Dosage: 1000 mg, bid
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Prilosec; Celexa; Aspirin; Propranolol; Prinivil; Prevacid; Bactrim DS; Spironolactone; Ultram; Allopurinol; Colchicine; Zyprexa; Trazodone HCL
Possible Prograf side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-05
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Vomiting, Nausea, Liver Transplant Rejection, Laceration, Headache, Constipation, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 4 mg, bid
Administration route: Oral
Indication: Liver Transplant
Start date: 2011-01-01
Prograf
Dosage: 1 mg, bid
Other drugs received by patient: Baraclude; Entecavir
Possible Prograf side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female, weighing 44.0 kg (96.8 pounds)
Reactions: Urinary Tract Infection, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Other drugs received by patient: Calcium with Vitamin D; Mycophenolate Mofetil (Cellcept); Prednisone; Centrum; Vitamin B-12
Possible Prograf side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: male
Reactions: Heart Transplant Rejection, Treatment Noncompliance
Drug(s) suspected as cause:
Prograf
Dosage: unk
Indication: Heart Transplant
Tacrolimus
Dosage: unk
Indication: Heart Transplant
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