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Prograf (Tacrolimus) - Diarrhoea - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Diarrhoea (75)

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

 Reports 1 - 30 of 75   Next >>

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 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 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



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 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 45 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17

Patient: 45 year old male

Reactions: Weight Decreased, Diarrhoea, Odynophagia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Indication: Product Used FOR Unknown Indication

Prograf
    Dosage: 4.0 mg, bid
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Humalog; Tamsulosin HCL; Magnesium; Levothyroxine Sodium; Trimethoprim + Sulfamethoxazole; Atorvastatin Calcium; Calcium Carbonate; Pantoprazole; Valacyclovir Hydrochloride; Humulin N; Prednisone TAB; Calcitrol / 00508501 /



Possible Prograf side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female, weighing 50.6 kg (111.3 pounds)

Reactions: Urinary Tract Infection, Cytomegalovirus Viraemia, Rhinorrhoea, Pyrexia, Renal Failure, Diarrhoea, Urosepsis, Neutropenia, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Indication: Prophylaxis

Mycophenolate Mofetil
    Dosage: unk
    Administration route: Oral
    Start date: 2011-05-16
    End date: 2011-06-04

Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-08-24
    End date: 2011-05-16

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
    Start date: 2011-05-16

Prograf
    Dosage: 4 mg am, 5 mg pm
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-09
    End date: 2011-05-16

Other drugs received by patient: Lasix; Losartan Potassium



Possible Prograf side effects in female

Reported by a physician from France on 2012-08-14

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Diarrhoea, Extranodal Marginal Zone B-Cell Lymphoma (Malt Type), General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 1000 mg, unknown/d
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-11-13

Prograf
    Dosage: 6.5 mg, unknown/d
    Indication: Renal Transplant
    Start date: 2007-11-13

Tacrolimus
    Dosage: 5 mg, unknown/d

Tacrolimus
    Dosage: 6 mg, unknown/d
    Indication: Renal Transplant
    Start date: 2012-01-20

Other drugs received by patient: Prednisone TAB; Corticosteroid NOS



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:
Antithymocyte Immunoglobulin (Rabbit)
    Dosage: 75 mg, unknown/d
    Indication: Kidney Transplant Rejection

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

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 2012-08-13

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Diarrhoea, Escherichia Urinary Tract Infection, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone TAB
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone TAB
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran



Possible Prograf side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Diarrhoea, Escherichia Urinary Tract Infection, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone TAB
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone TAB
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran



Possible Prograf side effects in male

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

Patient: male

Reactions: Diarrhoea, Pulmonary Embolism, Gastroenteritis Salmonella

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-27

Prograf
    Dosage: 1 mg, bid
    Administration route: Oral
    Start date: 2011-06-08

Prograf
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2011-01-28

Other drugs received by patient: Prednisone; Coumadin; Prednisone



Possible Prograf side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Escherichia Urinary Tract Infection, Diarrhoea, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran



Possible Prograf side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Escherichia Urinary Tract Infection, Diarrhoea, Gastric Antral Vascular Ectasia, Concomitant Disease Progression, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: 1000 mg, bid
    Indication: Urinary Tract Infection
    Start date: 2011-08-28
    End date: 2011-09-01

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-27
    End date: 2011-07-12

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-07-25
    End date: 2011-08-29

Imuran
    Dosage: 150 mg, qd
    Indication: Immunosuppression
    Start date: 2011-08-30
    End date: 2011-09-01

Nexium
    Dosage: unk

Prednisone
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-01
    End date: 2011-07-13

Prednisone
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-07-14

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-06-28

Valcyte
    Dosage: 450 mg, qd
    Start date: 2011-06-27

Other drugs received by patient: Iron Dextran; Iron Dextran; Iron Dextran



Possible Prograf side effects in 84 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-31

Patient: 84 year old female, weighing 36.0 kg (79.2 pounds)

Reactions: Cardiac Failure, Diarrhoea, Hyponatraemia, Altered State of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Candesartan Cilexetil
    Dosage: tab
    Administration route: Oral
    End date: 2012-07-09

Orencia
    Dosage: 6may,20may,1jul,28jul,19aug.16sep,13oct11
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-22
    End date: 2012-07-09

Prograf
    Indication: Rheumatoid Arthritis
    End date: 2012-06-06

Other drugs received by patient: Celecoxib; Lasix; Sulfamethoxazole and Trimethoprim; Aspirin; Sulfasalazine; Prednisolone; Mucosta; Lyrica; Prednisolone; Ketoprofen; Basen; Maglax; Alendronate Sodium; Bucillamine; Lipitor; Loxonin; Depas; Actarit; Estazolam; Lansoprazole



Possible Prograf side effects in 84 year old female

Reported by a physician from Japan on 2012-07-27

Patient: 84 year old female, weighing 36.0 kg (79.2 pounds)

Reactions: Diarrhoea, Cardiac Failure, Hyponatraemia, Altered State of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Candesartan Cilexetil
    Dosage: tab
    Administration route: Oral
    End date: 2012-07-09

Orencia
    Dosage: 6may,20may,1jul,28jul,19aug.16sep,13oct11
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-22
    End date: 2012-07-09

Prograf
    Indication: Rheumatoid Arthritis
    End date: 2012-06-06

Other drugs received by patient: Ketoprofen; Lansoprazole; Actarit; Sulfamethoxazole and Trimethoprim; Prednisolone; Mucosta; Aspirin; Lyrica; Bucillamine; Prednisolone; Loxonin; Maglax; Lipitor; Sulfasalazine; Estazolam; Celecoxib; Depas; Basen; Lasix; Alendronate Sodium



Possible Prograf side effects in female

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

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

Leflunomide

Mycophenolate Mofetil
    Dosage: 250 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-24
    End date: 2012-01-29

Prednisone
    Indication: Immunosuppression

Prednisone
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28

Prograf
    Dosage: 01 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 United States on 2012-07-26

Patient: female, weighing 50.6 kg (111.3 pounds)

Reactions: Nausea, Urinary Tract Infection, Cytomegalovirus Viraemia, Rhinorrhoea, Pyrexia, Renal Failure, Diarrhoea, Urosepsis, Neutropenia, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Indication: Prophylaxis

Mycophenolate Mofetil
    Dosage: unk
    Administration route: Oral
    Start date: 2011-05-16
    End date: 2011-06-04

Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-08-24
    End date: 2011-05-16

Prednisone
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-10-23

Prograf
    Dosage: 4 mg am, 5 mg pm
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-09
    End date: 2011-05-16

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Start date: 2011-05-16

Other drugs received by patient: Losartan Potassium; Lasix



Possible Prograf side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female, weighing 51.4 kg (113.1 pounds)

Reactions: Nausea, 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 Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    End date: 2011-05-16

Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    Start date: 2011-05-16
    End date: 2011-06-04

Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-08-24
    End date: 2011-05-04

Prednisone
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-10-23

Prograf
    Dosage: 4 mg am, 5 mg pm
    Administration route: Oral
    End date: 2011-05-16

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Start date: 2011-05-24

Prograf
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-12-09

Prograf
    Dosage: unk
    Administration route: Oral
    Start date: 2011-05-16

Other drugs received by patient: Losartan Potassium; Lasix



Possible Prograf side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-18

Patient: male

Reactions: Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Enterococcal Infection, Coagulopathy, Cardiac Failure Acute, Pneumonia Cytomegaloviral, Pneumocystis Jiroveci Pneumonia, Anal Fistula, Colonic Fistula, Acute Respiratory Distress Syndrome, Circulatory Collapse, Apnoea, Melaena, Cytomegalovirus Enterocolitis, Metabolic Acidosis, Gastrointestinal Ulcer Haemorrhage, Restlessness, Hyperglycaemia, Anaemia, Duodenal Ulcer, Ulcer, Delirium, Fungal Infection, Insomnia, Systemic Inflammatory Response Syndrome, Septic Shock, Hypoventilation, Oral Administration Complication, Shock Haemorrhagic, Ileal Ulcer, Interstitial Lung Disease, Large Intestinal Ulcer, Ileal Fistula, Small Intestinal Haemorrhage, Acute Respiratory Failure, Dyspnoea, Diarrhoea, Respiratory Failure, Sepsis, Anal Haemorrhage, Purulence, Hypertension

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Bredinin
    Dosage: 100 mg, daily
    Administration route: Oral
    End date: 2011-03-08

Mycophenolate Mofetil
    Indication: Renal Transplant

Neoral
    Dosage: 100 mg, daily
    Administration route: Oral
    Start date: 2010-11-18
    End date: 2011-03-15

Neoral
    Dosage: 50 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    End date: 2011-03-15

Prednisolone
    Dosage: 10 mg, unk
    End date: 2011-03-22

Prednisolone
    Dosage: 10 mg, daily
    Administration route: Oral
    End date: 2011-03-18

Prograf
    Dosage: 2 mg, daily
    Administration route: Oral
    End date: 2011-11-17

Rituximab
    Dosage: unk ukn, unk

Other drugs received by patient: Insulin



Possible Prograf side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-18

Patient: male

Reactions: Gastrointestinal Haemorrhage, Coagulopathy, Disseminated Intravascular Coagulation, Enterococcal Infection, Cardiac Failure Acute, Pneumonia Cytomegaloviral, Anal Fistula, Pneumocystis Jiroveci Pneumonia, Colonic Fistula, Acute Respiratory Distress Syndrome, Circulatory Collapse, Apnoea, Melaena, Cytomegalovirus Enterocolitis, Metabolic Acidosis, Restlessness, Gastrointestinal Ulcer Haemorrhage, Anaemia, Hyperglycaemia, Duodenal Ulcer, Ulcer, Delirium, Fungal Infection, Insomnia, Systemic Inflammatory Response Syndrome, Septic Shock, Hypoventilation, Oral Administration Complication, Shock Haemorrhagic, Ileal Ulcer, Interstitial Lung Disease, Ileal Fistula, Large Intestinal Ulcer, Small Intestinal Haemorrhage, Acute Respiratory Failure, Dyspnoea, Diarrhoea, Respiratory Failure, Sepsis, Purulence, Anal Haemorrhage, Hypertension

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Bredinin
    Dosage: 100 mg, daily
    Administration route: Oral
    End date: 2011-03-08

Mycophenolate Mofetil
    Indication: Renal Transplant

Neoral
    Dosage: 50 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    End date: 2011-03-15

Neoral
    Dosage: 100 mg, daily
    Administration route: Oral
    Start date: 2010-11-18
    End date: 2011-03-15

Prednisolone
    Dosage: 10 mg, daily
    Administration route: Oral
    End date: 2011-03-18

Prednisolone
    Dosage: 10 mg, unk
    End date: 2011-03-22

Prograf
    Dosage: 2 mg, daily
    Administration route: Oral
    End date: 2011-11-17

Rituximab
    Dosage: unk ukn, unk

Other drugs received by patient: Insulin



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:
Anti-Thymocyte Globulin Rabbit NOS
    Dosage: 75 mg, unknown/d
    Indication: Kidney Transplant Rejection

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

Prograf
    Dosage: 4 mg, q12 hours
    Administration route: Oral

Protein Pump Inhibitor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Prograf side effects in 41 year old female

Reported by a physician from Germany on 2012-07-12

Patient: 41 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Pneumonia Klebsiella, Diarrhoea, Urinary Tract Infection, Urosepsis, Hyperthyroidism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azathioprine
    Dosage: 50 mg, qd
    Indication: Immunosuppression
    Start date: 2011-02-01
    End date: 2012-04-16

Mycophenolic Acid
    Dosage: unk
    Indication: Pancreas Transplant
    End date: 2012-01-17

Prednisolone
    Dosage: 5 mg, qd
    Start date: 2011-11-18

Prednisolone
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2011-11-17

Prograf
    Dosage: 3.5 mg, bid
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2011-11-17



Possible Prograf side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male, weighing 59.0 kg (129.8 pounds)

Reactions: Abdominal Pain, Suprapubic Pain, Diarrhoea, Neutropenia, Catheter Site Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asp8597 Blinded
    Dosage: 5.9 ml (400 mg,) unk
    Indication: Renal Transplant
    Start date: 2012-04-09
    End date: 2012-04-09

Cellcept
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-10
    End date: 2012-04-26

Cellcept
    Dosage: 500 mg, bid
    Start date: 2012-05-03

Cellcept
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2012-04-28
    End date: 2012-04-29

Cellcept
    Dosage: 1000 mg, bid
    Administration route: Oral
    Start date: 2012-06-11

Cellcept
    Dosage: 750 mg, qd
    Administration route: Oral
    Start date: 2012-05-02
    End date: 2012-05-02

Cellcept
    Dosage: 750 mg, bid
    Administration route: Oral
    Start date: 2012-04-26
    End date: 2012-04-01

Cellcept
    Dosage: 250 mg, pm
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-05-01

Prograf
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-10

Thymoglobulin
    Dosage: 100 unk, qd
    Start date: 2012-04-11
    End date: 2012-04-11

Thymoglobulin
    Dosage: 125 unk, qd
    Indication: Renal Transplant
    Start date: 2012-04-09
    End date: 2012-04-10

Valcyte
    Dosage: 450 mg, qd
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-04-10
    End date: 2012-04-13

Valcyte
    Dosage: 450 mg, 3x/w
    Administration route: Oral
    Start date: 2012-05-04

Valcyte
    Dosage: 450 mg, 3x/w
    Administration route: Oral
    Start date: 2012-04-16
    End date: 2012-04-28



Possible Prograf side effects in female

Reported by a physician from France on 2012-06-25

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Diarrhoea, General Physical Health Deterioration, Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 2 df, unknown/d
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-11-13

Prograf
    Dosage: 6.5 mg, unknown/d
    Indication: Renal Transplant
    Start date: 2007-11-13

Tacrolimus
    Dosage: 6 mg, unknown/d
    Indication: Renal Transplant
    Start date: 2012-01-20

Other drugs received by patient: Prednisone TAB; Corticosteroid NOS



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:
Anti-Thymocyte Globulin Rabbit NOS
    Dosage: 75 mg, unknown/d
    Indication: Kidney Transplant Rejection

Prograf
    Dosage: 1 mg, uid/qd
    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: 5 mg, q12 hours
    Administration route: Oral

Protein Pump Inhibitor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Prograf side effects in female

Reported by a physician from Japan on 2012-06-08

Patient: female

Reactions: Abdominal Pain, Lymphadenopathy, Snoring, Laryngeal Oedema, Pyrexia, Pericardial Effusion, Hypercholesterolaemia, C-Reactive Protein Increased, Heart Transplant Rejection, Laryngeal Neoplasm, Cardiac Hypertrophy, White Blood Cell Count Increased, Pneumonia, Vomiting, Post Transplant Lymphoproliferative Disorder, Brain Natriuretic Peptide Increased, Diarrhoea, Bronchitis, Myocardial Oedema, Obstructive Airways Disorder, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 125 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2004-08-02

Certican
    Dosage: unk
    Start date: 2007-08-06

Certican
    Dosage: 1.5 mg, unk
    Administration route: Oral
    Start date: 2005-03-04
    End date: 2005-05-16

Certican
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2005-02-21

Certican
    Dosage: 1 mg, qd
    Administration route: Oral
    Start date: 2005-02-28
    End date: 2005-03-03

Certican
    Dosage: unk
    Start date: 2007-02-20

Prednisolone
    Dosage: 2 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2001-05-01

Prograf
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2005-02-28
    End date: 2005-03-13

Prograf
    Dosage: 2.8 mg, unk
    Administration route: Oral
    Start date: 2005-03-14

Prograf
    Dosage: 3.6 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    End date: 2005-02-27

Tacrolimus
    Indication: Heart Transplant

Other drugs received by patient: Rituximab; Cotrim; Polygam S / D; Prednisolone; Enalapril Maleate



Possible Prograf side effects in female

Reported by a physician from Japan on 2012-06-07

Patient: female, weighing 13.0 kg (28.6 pounds)

Reactions: Nasopharyngitis, Nausea, Pyrexia, Respiratory Syncytial Virus Infection, Renal Impairment, Diarrhoea, Interstitial Lung Disease, Heart Transplant Rejection, Rash Erythematous, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azathioprine
    Administration route: Oral
    Indication: Heart Transplant

Cellcept
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2009-02-01

Certican
    Dosage: 1 mg, unk
    Administration route: Oral
    Start date: 2006-01-30
    End date: 2006-02-03

Certican
    Dosage: 0.75 mg, unk
    Administration route: Oral
    Start date: 2006-02-03
    End date: 2006-04-24

Certican
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2006-01-23
    End date: 2006-01-30

Certican
    Dosage: 1 mg, daily
    Administration route: Oral
    Start date: 2008-01-23
    End date: 2009-01-22

Certican
    Dosage: unk
    Administration route: Oral
    End date: 2009-02-05

Certican
    Dosage: unk

Neoral
    Indication: Heart Transplant

Prograf
    Dosage: 4.5 mg, unk
    Administration route: Oral
    Start date: 2006-01-23
    End date: 2006-02-16

Prograf
    Dosage: 4.8 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    End date: 2006-01-23

Prograf
    Dosage: 4.0 mg, unk
    Administration route: Oral
    Start date: 2006-03-20
    End date: 2006-04-24

Prograf
    Dosage: 3.0 mg, unk
    Administration route: Oral
    Start date: 2006-02-16
    End date: 2006-03-20

Tacrolimus
    Indication: Heart Transplant

Other drugs received by patient: Everolimus; Tenormin; Sirolimus; Famotidine



Possible Prograf side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-01

Patient: female, weighing 54.1 kg (119.0 pounds)

Reactions: Diarrhoea, Hypotension, Cytomegalovirus Viraemia, Pyrexia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Start date: 2011-09-10
    End date: 2012-01-16

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-29
    End date: 2011-02-02

Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Start date: 2011-02-03
    End date: 2011-09-09

Leflunomide

Prednisone TAB
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28

Prograf
    Dosage: 01 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-28
    End date: 2012-01-16

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 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:
Anti-Thymocyte Globulin Rabbit NOS
    Dosage: 75 mg, unknown/d
    Indication: Kidney Transplant Rejection

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

Prograf
    Dosage: 5 mg, q12 hours
    Administration route: Oral

Protein Pump Inhibitor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



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