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RAPAMUNE

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Rapamune Adverse Events Reported to the FDA Over Time

How are Rapamune adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Rapamune, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rapamune is flagged as the suspect drug causing the adverse event.

Most Common Rapamune Adverse Events Reported to the FDA

What are the most common Rapamune adverse events reported to the FDA?

Kidney Transplant Rejection
545 (3.18%)
Blood Creatinine Increased
293 (1.71%)
Drug Ineffective
254 (1.48%)
Pyrexia
227 (1.33%)
Complications Of Transplanted Kidne...
216 (1.26%)
Diarrhoea
213 (1.24%)
Haemoglobin Decreased
193 (1.13%)
Haematocrit Decreased
152 (.89%)
Renal Failure Acute
152 (.89%)
Anaemia
148 (.86%)
Renal Tubular Necrosis
147 (.86%)
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Pneumonia
140 (.82%)
Death
135 (.79%)
Dyspnoea
133 (.78%)
Condition Aggravated
131 (.77%)
Vomiting
131 (.77%)
Immunosuppressant Drug Level Increa...
126 (.74%)
Haemodialysis
122 (.71%)
Renal Impairment
120 (.7%)
Dehydration
119 (.7%)
Transplant Rejection
114 (.67%)
Oedema Peripheral
113 (.66%)
Renal Failure
102 (.6%)
Asthenia
101 (.59%)
Nausea
99 (.58%)
Thrombocytopenia
96 (.56%)
Liver Transplant Rejection
91 (.53%)
Venoocclusive Liver Disease
91 (.53%)
Blood Urea Increased
89 (.52%)
Drug Toxicity
86 (.5%)
Pneumonitis
86 (.5%)
Thrombotic Microangiopathy
83 (.49%)
Weight Decreased
80 (.47%)
Blood Glucose Increased
78 (.46%)
Platelet Count Decreased
77 (.45%)
Hypertension
76 (.44%)
Pleural Effusion
74 (.43%)
Hypotension
73 (.43%)
Sepsis
71 (.41%)
General Physical Health Deteriorati...
70 (.41%)
Proteinuria
69 (.4%)
Blood Lactate Dehydrogenase Increas...
66 (.39%)
Leukopenia
66 (.39%)
Interstitial Lung Disease
64 (.37%)
Dialysis
62 (.36%)
Drug Interaction
62 (.36%)
Multi-organ Failure
62 (.36%)
Deep Vein Thrombosis
60 (.35%)
Cytomegalovirus Infection
58 (.34%)
Diabetes Mellitus
58 (.34%)
White Blood Cell Count Decreased
58 (.34%)
Alanine Aminotransferase Increased
57 (.33%)
Immunosuppression
57 (.33%)
Infection
57 (.33%)
Myocardial Infarction
57 (.33%)
Aspartate Aminotransferase Increase...
56 (.33%)
Blood Alkaline Phosphatase Increase...
56 (.33%)
Lymphocele
56 (.33%)
Post Procedural Complication
55 (.32%)
Urinary Tract Infection
53 (.31%)
Graft Dysfunction
52 (.3%)
Atrial Fibrillation
51 (.3%)
Cough
51 (.3%)
Blood Creatine Increased
50 (.29%)
Pericardial Effusion
50 (.29%)
Blood Triglycerides Increased
48 (.28%)
Oedema
47 (.27%)
Disease Progression
46 (.27%)
Rash
46 (.27%)
Chest Pain
45 (.26%)
Respiratory Failure
45 (.26%)
Immunosuppressant Drug Level Decrea...
44 (.26%)
Malaise
44 (.26%)
Nephropathy Toxic
44 (.26%)
Arthralgia
43 (.25%)
C-reactive Protein Increased
43 (.25%)
Cardiac Failure
43 (.25%)
Fluid Overload
43 (.25%)
Abdominal Pain
42 (.25%)
Atelectasis
41 (.24%)
Impaired Healing
41 (.24%)
Nephrotic Syndrome
41 (.24%)
Blood Cholesterol Increased
40 (.23%)
Pulmonary Oedema
40 (.23%)
Cardiac Arrest
39 (.23%)
Disease Recurrence
39 (.23%)
Lung Disorder
39 (.23%)
Fatigue
38 (.22%)
Cholestasis
37 (.22%)
Convulsion
37 (.22%)
Hydronephrosis
37 (.22%)
Lung Infiltration
36 (.21%)
Lymphadenopathy
36 (.21%)
Hyperlipidaemia
35 (.2%)
Pulmonary Embolism
35 (.2%)
Acute Respiratory Distress Syndrome
34 (.2%)
Cellulitis
34 (.2%)
Hypoxia
34 (.2%)
Cardiomegaly
33 (.19%)
Cerebrovascular Accident
33 (.19%)
Headache
33 (.19%)

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This graph shows the top adverse events submitted to the FDA for Rapamune, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rapamune is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Rapamune

What are the most common Rapamune adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Rapamune, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rapamune is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Rapamune According to Those Reporting Adverse Events

Why are people taking Rapamune, according to those reporting adverse events to the FDA?

Prophylaxis Against Transplant Reje...
2570
Renal Transplant
355
Immunosuppressant Drug Therapy
235
Immunosuppression
144
Graft Versus Host Disease
81
Liver Transplant
78
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Heart Transplant
61
Product Used For Unknown Indication
49
Drug Use For Unknown Indication
42
Glioblastoma Multiforme
31
Lung Transplant
31
Transplant
25
Prophylaxis
18
Kidney Transplant Rejection
17
Prophylaxis Against Graft Versus Ho...
17
Pancreas Islet Cell Transplant
17
Bone Marrow Transplant
11
Transplant Rejection
10
Lymphangioleiomyomatosis
10
Kaposis Sarcoma
9
Renal And Pancreas Transplant
9
Stem Cell Transplant
8
Blood Creatinine Increased
8
Intestinal Transplant
7
Hepatic Neoplasm Malignant Recurren...
7
Renal Impairment
7
Metastatic Renal Cell Carcinoma
7
Acute Myeloid Leukaemia
7
Renal Disorder
6
Pancreas Transplant
6
Organ Transplant
6
Liver Disorder
5
Sarcoma
5
Tuberous Sclerosis
5
Small Cell Lung Cancer Stage Unspec...
5
Gastrointestinal Stromal Tumour
4
Wegeners Granulomatosis
4
Angiomyolipoma
4
Glomerulonephritis Chronic
4
Neoplasm Prophylaxis
4
Ewings Sarcoma
4
Immunosuppressant Drug Level
4
Heart Transplant Rejection
3
Neurofibromatosis
3
Glioma
3
Complications Of Transplant Surgery
3
Squamous Cell Carcinoma
3
Skin Cancer
3
Pulmonary Hypertension
2
Pancreatic Carcinoma
2
Psoriasis
2

Drug Labels

LabelLabelerEffective
RapamuneCardinal Health29-APR-11
RapamuneWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.14-DEC-12

Rapamune Case Reports

What Rapamune safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Rapamune. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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