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Index of reports
> Life Threatening Events (3)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Rapamune (Sirolimus) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
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 56 year old male
Reported by a physician from Serbia on 2012-04-23
Patient: 56 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Weight Decreased, Back Pain, Dysphagia, General Physical Health Deterioration, Schizophrenia, Pyrexia, Oropharyngeal Pain, Suicidal Ideation, Cardio-Respiratory Arrest, Psychotic Disorder, Insomnia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Rapamune
Dosage: 1 mg, 1x/day
Administration route: Oral
Indication: Prophylaxis Against Transplant Rejection
Start date: 2009-11-20
End date: 2011-05-01
Rapamune
Dosage: 1 mg 1+0+0 (every third day 1/2 pill)
Midazolam
Dosage: 15 mg 0+0+2
Other drugs received by patient: Prednisone; Ibuprofen; Propranolol; Propranolol; Andaxin; Urso Falk; Furosemide
Possible Rapamune side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: female, weighing 81.6 kg (179.6 pounds)
Reactions: Pneumonia, Transplant Rejection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Rapamune
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