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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