DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Rapamune (Sirolimus) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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 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 male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Renal Disorder, Diabetes Mellitus

Drug(s) suspected as cause:
Rapamune
    Dosage: 0.5 mg, 1x/day

Rapamune
    Dosage: 1 mg, unk
    Start date: 2011-03-25

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014