This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rapamune (Sirolimus) 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 (257)
Death (66)
Life Threatening Events (3)
Disability (1)
Reports by Reaction Type
Death (31),
Diarrhoea (17),
Disease Progression (15),
Oedema Peripheral (15),
Pneumonia (12),
Drug Ineffective (11),
Interstitial Lung Disease (10),
Weight Decreased (9),
Dyspnoea (9),
Graft Versus Host Disease (8),
Headache (8),
Abortion Spontaneous (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Rapamune (Sirolimus). For a complete list or a specific selection of reports, please use the links above.
Possible Rapamune side effects in female
Reported by a consumer/non-health professional from Colombia on 2012-08-27
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in male
Reported by a consumer/non-health professional from Colombia on 2012-08-27
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Feeling Abnormal
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 21 year old female
Reported by a physician from United States on 2012-08-23
Patient: 21 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Mycophenolate Mofetil
Dosage: 750 mg, 2x/day
Administration route: Oral
Indication: Prophylaxis Against Transplant Rejection
Start date: 2011-06-22
End date: 2012-01-26
Rapamune
Other drugs received by patient: Prednisone; Sulfamethoxazole and Trimethoprim; Omeprazole; Lisinopril; Atorvastatin Calcium; Tacrolimus
Possible Rapamune side effects in male
Reported by a consumer/non-health professional from Colombia on 2012-08-23
Patient: male
Reactions: Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Other drugs received by patient: Mycophenolate Mofetil
Possible Rapamune side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 55 year old female, weighing 90.7 kg (199.5 pounds)
Reactions: Off Label Use, Diarrhoea, Constipation
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 47 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 47 year old male
Reactions: Leukaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 75 year old male, weighing 56.2 kg (123.7 pounds)
Reactions: Aphagia, Malaise, Activities of Daily Living Impaired, Dehydration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: female, weighing 52.2 kg (114.8 pounds)
Reactions: Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bevacizumab
Rapamune
Possible Rapamune side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 20 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Mycophenolate Mefetil
Dosage: 750 mg, 2x/day
Administration route: Oral
Indication: Transplant
End date: 2011-05-26
Rapamune
Dosage: 3 mg, 1x/day
Administration route: Oral
Indication: Transplant
End date: 2011-05-26
Other drugs received by patient: Tacrolimus; Prednisone; Sulfamethoxazole and Trimethoprim; Atorvastatin Calcium; Omeprazole; Lisinopril; Tacrolimus
Possible Rapamune side effects in 21 year old female
Reported by a physician from United States on 2012-08-20
Patient: 21 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Rapamune
Other drugs received by patient: Mycophenolate Mofetil; Omeprazole; Tacrolimus; Prednisone; Sulfamethoxazole and Trimethoprim; Atorvastatin Calcium; Lisinopril
Possible Rapamune side effects in 41 year old male
Reported by a consumer/non-health professional from Brazil on 2012-08-17
Patient: 41 year old male, weighing 71.0 kg (156.2 pounds)
Reactions: Weight Decreased, Diarrhoea, Flatulence, Expired Drug Administered
Drug(s) suspected as cause:
Rapamune
Other drugs received by patient: Ferrous Sulfate; Corus; Prednisone; Angiopril; Myfortic
Possible Rapamune side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 43 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 20 year old female
Reported by a physician from United States on 2012-08-17
Patient: 20 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Rapamune
Other drugs received by patient: Mycophenolate Mofetil; Omeprazole; Prednisone; Lisinopril; Tacrolimus; Tacrolimus; Sulfamethoxazole and Trimethoprim; Atorvastatin Calcium
Possible Rapamune side effects in 82 year old male
Reported by a pharmacist from United States on 2012-08-16
Patient: 82 year old male
Reactions: Colon Cancer, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Blood Pressure Increased, Blood Cholesterol Increased, Atrioventricular Block, Myocardial Infarction
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 53 year old male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 53 year old male
Reactions: Neoplasm Malignant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 48 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16
Patient: 48 year old male
Reactions: Cytolytic Hepatitis, Hypertriglyceridaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: male
Reactions: Vomiting, Nausea
Drug(s) suspected as cause:
Rapamune
Dosage: 3 mg, 1x/day
Administration route: Oral
Start date: 2012-08-05
Rapamune
Dosage: 5 mg (five of 1mg), 1x/day
Administration route: Oral
Indication: Prophylaxis Against Transplant Rejection
Start date: 2012-08-04
End date: 2012-08-05
Other drugs received by patient: Myfortic; Epivir; Bactrim; Flomax; Prograf; Acyclovir; Ursodiol; Norvasc; Pepcid; Zoloft
Possible Rapamune side effects in 82 year old male
Reported by a physician from United States on 2012-08-10
Patient: 82 year old male
Reactions: Colon Cancer, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 67 year old male
Reported by a physician from United States on 2012-08-08
Patient: 67 year old male
Reactions: Bone Marrow Disorder, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 60 year old male
Reported by a physician from United States on 2012-08-07
Patient: 60 year old male
Reactions: Lymphoedema
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 68 year old male
Reported by a physician from France on 2012-08-03
Patient: 68 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Oesophageal Carcinoma, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Prograf
Dosage: 4 mg, 1x/day from randomization
Start date: 2008-01-29
End date: 2008-12-22
Prograf
Dosage: 10 mg, 1x/day, until randomization
Indication: Immunosuppression
Start date: 2007-12-27
End date: 2008-01-28
Prograf
Dosage: 1 mg, 1x/day
Start date: 2009-06-22
End date: 2010-06-17
Prograf
Dosage: 2 mg, 1x/day
Start date: 2008-12-23
End date: 2009-06-21
Rapamune
Dosage: 1 mg, 1x/day
Administration route: Oral
Start date: 2008-12-23
Rapamune
Dosage: 2 mg, 1x/day
Administration route: Oral
Indication: Prophylaxis Against Transplant Rejection
Start date: 2008-01-28
End date: 2008-12-22
Other drugs received by patient: Levothyroxine Sodium; Plavix; Cordarone; Omeprazole; Lamivudine
Possible Rapamune side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: male
Reactions: Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 79 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: 79 year old male
Reactions: Bronchospasm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclosporine
Administration route: Oral
Indication: Immunosuppression
Pentamidine
Indication: Infection Prophylaxis
Rapamune
Administration route: Oral
Indication: Immunosuppression
Thymoglobulin
Indication: Immunosuppression
Possible Rapamune side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: male
Reactions: Colon Cancer, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 11 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-01
Patient: 11 year old female
Reactions: Organising Pneumonia, Post Transplant Lymphoproliferative Disorder, Epstein-Barr Virus Infection, Diarrhoea, Transplant Rejection
Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
Indication: Product Used FOR Unknown Indication
Azathioprine
Indication: Product Used FOR Unknown Indication
Methylprednisolone
Indication: Product Used FOR Unknown Indication
Mycophenolate Mofetil
Indication: Prophylaxis Against Transplant Rejection
Prednisone
Indication: Product Used FOR Unknown Indication
Rapamune
Indication: Product Used FOR Unknown Indication
Rituximab
Indication: Post Transplant Lymphoproliferative Disorder
Tacrolimus
Indication: Product Used FOR Unknown Indication
Possible Rapamune side effects in 35 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: 35 year old male
Reactions: Cerebral Haematoma
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cyclosporine
Administration route: Oral
Indication: Immunosuppression
Rapamune
Administration route: Oral
Indication: Immunosuppression
Thymoglobulin
Dosage: unk
Indication: Immunosuppression
Possible Rapamune side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rapamune
Possible Rapamune side effects in 40 year old male
Reported by a physician from Turkey on 2012-07-25
Patient: 40 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Blood Urea Increased, Blood Creatine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rapamune
Other drugs received by patient: Deltacortril; Tacrolimus; Azathioprine
|