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Zortress (Everolimus) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zortress (Everolimus) 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 (58)
Death (9)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Liver Transplant Rejection (13)Pancytopenia (9)Abdominal Pain (8)Liver Function Test Abnormal (8)Pyrexia (7)Anaemia (7)Transaminases Increased (6)Thrombocytopenia (6)Hepatic Enzyme Increased (6)Hepatitis C (5)Renal Failure Acute (5)Concomitant Disease Progression (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Zortress (Everolimus). For a complete list or a specific selection of reports, please use the links above.

Possible Zortress side effects in 62 year old female

Reported by a physician from United States on 2012-08-23

Patient: 62 year old female, weighing 62.3 kg (137.1 pounds)

Reactions: Small Intestinal Obstruction, Respiratory Failure, Post Procedural Complication, Enterocutaneous Fistula, Mental Status Changes Postoperative, Lower Gastrointestinal Haemorrhage, Abdominal Adhesions

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 0.75 mg, bid, oral
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-06-19
    End date: 2012-07-26

Myfortic
    Dosage: 360 mg, bid, oral
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2006-01-01
    End date: 2012-07-26

Other drugs received by patient: Prednisone; Glipizide



Possible Zortress side effects in 44 year old female

Reported by a physician from United States on 2012-08-23

Patient: 44 year old female, weighing 148.3 kg (326.3 pounds)

Reactions: Urine Protein / Creatinine Ratio Increased, Antibody Test Positive

Drug(s) suspected as cause:
Zortress

Other drugs received by patient: Prednisone; Aranesp



Possible Zortress side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Nephropathy Toxic, Toxicity To Various Agents, Renal Failure Chronic, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: unk
    Indication: Heart Transplant

Cyclosporine
    Dosage: unk
    Indication: Heart Transplant



Possible Zortress side effects in male

Reported by a physician from France on 2012-07-25

Patient: male

Reactions: Lung Infection, Pleural Effusion, Pulmonary Oedema, Left Ventricular Failure, Respiratory Distress

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Dosage: 70 mg, qd
    Indication: Renal Transplant
    Start date: 2012-01-27

Cellcept
    Dosage: 3 g, qd
    Indication: Renal Transplant
    Start date: 2012-01-26

Zortress
    Dosage: 1.25 mg, qd
    End date: 2012-04-03

Zortress
    Dosage: 4 mg, qd
    Indication: Renal Transplant
    Start date: 2012-01-31
    End date: 2012-03-28



Possible Zortress side effects in male

Reported by a physician from France on 2012-07-13

Patient: male

Reactions: Anaemia, Renal Impairment, Enterococcal Sepsis, Neutropenia, Thrombocytopenia, Wound Evisceration, Pyelonephritis, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27
    End date: 2012-04-17

Prograf
    Dosage: 12 mg, qd
    Start date: 2012-04-18

Zortress
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-02
    End date: 2012-04-17

Prednisone TAB
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27



Possible Zortress side effects in

Reported by a physician from United States on 2012-06-25

Patient:

Reactions: Intestinal Ulcer

Drug(s) suspected as cause:
Zortress



Possible Zortress side effects in male

Reported by a physician from France on 2012-06-18

Patient: male

Reactions: Small Intestinal Obstruction, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress

Other drugs received by patient: Cell Cept; Prednisolone



Possible Zortress side effects in male

Reported by a physician from NEW Zealand on 2012-06-11

Patient: male, weighing 76.5 kg (168.3 pounds)

Reactions: Pulmonary Embolism, Pulmonary Oedema, Lobar Pneumonia, Lower Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress

Other drugs received by patient: Humalog; Metformin HCL; Citalopram



Possible Zortress side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: female, weighing 51.8 kg (114.0 pounds)

Reactions: Viral Infection, Anaemia, Cytomegalovirus Infection, Bacterial Infection, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 0.25mg 3 pills bid po
    Administration route: Oral
    Start date: 2012-05-04

Mycophenolate Mofetil
    Dosage: 250mg 4 caps bid po
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-09-01
    End date: 2012-04-11



Possible Zortress side effects in male

Reported by a physician from France on 2012-05-23

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Ureteric Anastomosis Complication, Hydronephrosis, Hyperkalaemia, Cystogram Abnormal, Renal Failure Acute, Lymphocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 4 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-02-28
    End date: 2011-04-11

Zortress
    Dosage: 4 mg, qd
    Administration route: Oral
    Start date: 2011-05-16
    End date: 2011-06-14

Other drugs received by patient: Cellcept; Valganciclovir; Prograf; Bactrim DS; Bisoprolol Fumarate; Ofloxacin; Tamsulosin HCL; Prednisone TAB; Esomeprazole Magnesium; Calciparine; Pentoxifylline; Alfuzosin HCL



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-21

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Abdominal Pain, Biliary Cirrhosis Primary, Cholestasis, Cytomegalovirus Viraemia, Device Dislocation, Biliary Dilatation, Traumatic Renal Injury, Renal Disorder, Lung Neoplasm, Pancytopenia, Renal Haematoma, Dilatation Intrahepatic Duct Acquired, Periportal Oedema, Anastomotic Complication, Colitis, Liver Transplant Rejection, Biliary Tract Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2010-03-24
    End date: 2011-02-22

Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Start date: 2011-04-01

Tacrolimus
    Dosage: 2 mg, bid
    Administration route: Oral

Tacrolimus
    Dosage: 5 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2010-02-23



Possible Zortress side effects in male

Reported by a physician from United States on 2012-05-18

Patient: male

Reactions: Vomiting, Immune Reconstitution Syndrome, Nausea, Ataxia, Rhinorrhoea, Pyrexia, Cerebellar Syndrome, Dysarthria, Malaise, Meningitis Cryptococcal, Dizziness, Intracranial Pressure Increased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: unk
    Administration route: Oral
    Indication: Liver Transplant
    End date: 2009-12-03

Tacrolimus
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Liver Transplant



Possible Zortress side effects in male

Reported by a physician from France on 2012-05-17

Patient: male

Reactions: Enterococcal Sepsis, Renal Impairment, Anaemia, Neutropenia, Thrombocytopenia, Wound Evisceration, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27
    End date: 2012-04-17

Prograf
    Dosage: 12 mg, qd
    Start date: 2012-04-18

Zortress
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-02
    End date: 2012-04-17

Prednisone TAB
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-17

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Transplant Failure, Multi-Organ Failure, Renal Failure, Hepatitis C, Respiratory Failure, Liver Transplant Rejection, Hepatic Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: 2mg am, 1.5mg pm
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-25
    End date: 2009-12-22

Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-25
    End date: 2009-12-21

Other drugs received by patient: Prednisone; Lactulose



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-17

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Post Transplant Lymphoproliferative Disorder, Abdominal Pain, Hepatitis C, Angina Pectoris, Liver Function Test Abnormal, Liver Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-25
    End date: 2009-12-22

Tacrolimus
    Dosage: 2mg am, 1.5mg pm
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-25
    End date: 2009-12-22

Prednisone
    Dosage: 12.5 mg, dailyk
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-24

Other drugs received by patient: Fluconazole



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-17

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Post Transplant Lymphoproliferative Disorder, Abdominal Pain, Angina Pectoris, Hepatitis C, Liver Function Test Abnormal, Liver Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-25
    End date: 2009-12-22

Tacrolimus
    Dosage: 2mg am, 1.5mg pm
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-25
    End date: 2009-12-22

Prednisone TAB
    Dosage: 12.5 mg, dailyk
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-24

Other drugs received by patient: Fluconazole



Possible Zortress side effects in male

Reported by a physician from United States on 2012-05-17

Patient: male, weighing 83.6 kg (183.9 pounds)

Reactions: Alcohol Abuse, Pancytopenia, Pyrexia, Transaminases Increased, Fall, Concomitant Disease Progression, Hepatic Steatosis, Hepatic Enzyme Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 1.5 mg, q12h
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-07-23
    End date: 2011-05-25

Augmentin
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2010-09-29
    End date: 2010-10-06

Tacrolimus
    Dosage: 1 g, unk
    Indication: Liver Transplant
    Start date: 2009-06-22
    End date: 2011-06-26

Other drugs received by patient: Prograf



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-16

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Abdominal Pain, Biliary Cirrhosis Primary, Cholestasis, Cytomegalovirus Viraemia, Device Dislocation, Bile Duct Stenosis, Herpes Simplex, Biliary Dilatation, Traumatic Renal Injury, Renal Disorder, Lung Neoplasm, Pancytopenia, Renal Haematoma, Dilatation Intrahepatic Duct Acquired, Periportal Oedema, Anastomotic Complication, Colitis, Liver Transplant Rejection, Liver Abscess, Biliary Tract Disorder, Enterocolitis Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2010-03-24
    End date: 2011-02-22

Tacrolimus
    Dosage: 5 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2010-02-23

Tacrolimus
    Dosage: 2 mg, bid
    Administration route: Oral

Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Start date: 2011-04-01



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-16

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Abdominal Pain, Post Transplant Lymphoproliferative Disorder, Angina Pectoris, Hepatitis C, Liver Function Test Abnormal, Liver Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-25
    End date: 2009-12-22

Prednisone TAB
    Dosage: 12.5 mg, dailyk
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-24

Tacrolimus
    Dosage: 2mg am, 1.5mg pm
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-25
    End date: 2009-12-22

Other drugs received by patient: Fluconazole



Possible Zortress side effects in female

Reported by a physician from United States on 2012-05-16

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Abdominal Pain, Post Transplant Lymphoproliferative Disorder, Hepatitis C, Angina Pectoris, Liver Function Test Abnormal, Liver Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: 2mg am, 1.5mg pm
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-25
    End date: 2009-12-22

Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-25
    End date: 2009-12-22

Prednisone
    Dosage: 12.5 mg, dailyk
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-10-24

Other drugs received by patient: Fluconazole



Possible Zortress side effects in male

Reported by a physician from France on 2012-05-15

Patient: male

Reactions: Renal Impairment, Enterococcal Sepsis, Anaemia, Neutropenia, Thrombocytopenia, Wound Evisceration, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 500 mg, qd
    Administration route: Oral

Prednisone TAB
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27

Zortress
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-02
    End date: 2012-04-17

Prograf
    Dosage: 12 mg, qd
    Start date: 2012-04-18

Cellcept
    Dosage: 2 g, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27
    End date: 2012-04-17



Possible Zortress side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: male, weighing 83.6 kg (183.9 pounds)

Reactions: Alcohol Abuse, Pancytopenia, Pyrexia, Fall, Concomitant Disease Progression, Transaminases Increased, Hepatic Steatosis, Hepatic Enzyme Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: 1 g, unk
    Indication: Liver Transplant
    Start date: 2009-06-22
    End date: 2011-06-26

Zortress
    Dosage: 1.5 mg, q12h
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-07-23
    End date: 2011-05-25

Augmentin
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2010-09-29
    End date: 2010-10-06

Other drugs received by patient: Prograf



Possible Zortress side effects in male

Reported by a physician from United States on 2012-05-09

Patient: male

Reactions: Incisional Hernia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zortress



Possible Zortress side effects in male

Reported by a physician from United States on 2012-05-08

Patient: male

Reactions: Gastrointestinal Ulcer, Gastrointestinal Haemorrhage, Haemorrhoids, Gastrointestinal Erosion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: unk
    Administration route: Oral
    Indication: Liver Transplant
    End date: 2008-12-30

Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    End date: 2008-12-30



Possible Zortress side effects in male

Reported by a physician from Brazil on 2012-05-04

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Drug Ineffective, Lung Infection, Kidney Transplant Rejection, Pyrexia, Pallor, Cardiomegaly, Interstitial Lung Disease, Glomerulonephritis, Proteinuria, Graft Loss, Blood Creatinine Increased, Thrombocytopenia, Cough, Metabolic Acidosis, Complications of Transplanted Kidney, Dyspnoea, Pneumonia, Anaemia, Pancytopenia, Renal Impairment, Cytomegalovirus Infection, Haemosiderosis, Bronchitis, Lung Infiltration, Nephropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2001-08-10
    End date: 2002-08-19

Zortress
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2001-08-10
    End date: 2002-07-03

Zortress
    Dosage: 2 mg, bid
    Administration route: Oral
    Start date: 2002-07-04
    End date: 2002-08-19

Other drugs received by patient: Prednisone TAB; Bactrim; Propranolol; Nifedipine



Possible Zortress side effects in male

Reported by a physician from France on 2012-05-03

Patient: male

Reactions: Anaemia, Eventration Procedure, Neutropenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-04-02
    End date: 2012-04-17

Prednisone TAB
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27

Mycophenolate Mofetil (Cellcept)
    Dosage: 2 g, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-27
    End date: 2012-04-17



Possible Zortress side effects in male

Reported by a physician from France on 2012-04-30

Patient: male, weighing 101.0 kg (222.2 pounds)

Reactions: Phlebitis, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zortress
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2011-01-03
    End date: 2011-01-07

Zortress
    Dosage: 4 mg, qd
    Start date: 2011-01-08
    End date: 2011-01-14

Zortress
    Dosage: 3.5 mg, qd
    Start date: 2011-01-15
    End date: 2011-01-19

Other drugs received by patient: Prednisone TAB; Mycophenolate Mofetil (Cellcept)



Possible Zortress side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zortress



Possible Zortress side effects in male

Reported by a physician from France on 2012-04-23

Patient: male

Reactions: Haematuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zortress

Other drugs received by patient: Prograf; Mycophenolate Mofetil (Cellcept)



Possible Zortress side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-17

Patient: female, weighing 66.2 kg (145.7 pounds)

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: 2.0 mg, unk
    Start date: 2009-12-31

Mycophenolate Mofetil
    Dosage: 500 mg, qd
    Indication: Immunosuppression
    Start date: 2009-11-13
    End date: 2009-11-19

Bactrim
    Dosage: 1 tab m/w/f
    Indication: Prophylaxis
    Start date: 2009-10-23
    End date: 2009-12-31

Zortress
    Dosage: 1 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2009-11-20
    End date: 2009-12-03

Tacrolimus
    Dosage: 1.0 mg, unk
    Indication: Liver Transplant
    Start date: 2009-10-22
    End date: 2009-10-26

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