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SIROLIMUS

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Sirolimus Adverse Events Reported to the FDA Over Time

How are Sirolimus adverse event reports trending over time?

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

Most Common Sirolimus Adverse Events Reported to the FDA

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

Kidney Transplant Rejection
147 (1.83%)
Blood Creatinine Increased
109 (1.36%)
Pyrexia
105 (1.31%)
Transplant Rejection
103 (1.28%)
Pneumonia
97 (1.21%)
Renal Impairment
76 (.95%)
Urinary Tract Infection
69 (.86%)
Liver Transplant Rejection
68 (.85%)
Anaemia
67 (.83%)
Sepsis
66 (.82%)
Proteinuria
61 (.76%)
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Cytomegalovirus Infection
60 (.75%)
Diarrhoea
59 (.73%)
Renal Failure Acute
58 (.72%)
Thrombotic Microangiopathy
57 (.71%)
Drug Interaction
52 (.65%)
Neutropenia
49 (.61%)
Diabetes Mellitus
48 (.6%)
Multi-organ Failure
48 (.6%)
Complications Of Transplanted Kidne...
47 (.59%)
Hypertension
47 (.59%)
Dyspnoea
44 (.55%)
Focal Glomerulosclerosis
44 (.55%)
Haemodialysis
44 (.55%)
Dehydration
43 (.54%)
Pleural Effusion
42 (.52%)
Cough
41 (.51%)
Death
41 (.51%)
Drug Toxicity
41 (.51%)
Disease Recurrence
40 (.5%)
Lymphocele
40 (.5%)
Renal Failure
40 (.5%)
Hyperlipidaemia
39 (.49%)
Infection
39 (.49%)
Leukopenia
37 (.46%)
Rash
37 (.46%)
Chronic Allograft Nephropathy
36 (.45%)
Drug Ineffective
34 (.42%)
Impaired Healing
34 (.42%)
Aspergillosis
33 (.41%)
Pneumonitis
32 (.4%)
Asthenia
31 (.39%)
Condition Aggravated
31 (.39%)
Haemoglobin Decreased
30 (.37%)
Headache
30 (.37%)
Nephropathy Toxic
30 (.37%)
Post Procedural Complication
30 (.37%)
Respiratory Failure
30 (.37%)
Thrombocytopenia
30 (.37%)
Cholangitis
29 (.36%)
Hypotension
29 (.36%)
Lymphadenopathy
29 (.36%)
Squamous Cell Carcinoma
29 (.36%)
Oedema Peripheral
28 (.35%)
Vomiting
28 (.35%)
Abdominal Pain
27 (.34%)
Gastroenteritis
27 (.34%)
Heart Transplant Rejection
27 (.34%)
Renal Failure Chronic
27 (.34%)
Chest Pain
25 (.31%)
Clostridium Difficile Colitis
25 (.31%)
Deep Vein Thrombosis
25 (.31%)
Septic Shock
25 (.31%)
Abdominal Pain Upper
24 (.3%)
Graft Dysfunction
23 (.29%)
Hepatic Function Abnormal
23 (.29%)
Hyperglycaemia
23 (.29%)
Myopathy
23 (.29%)
Nausea
23 (.29%)
Platelet Count Decreased
23 (.29%)
Enterococcal Infection
22 (.27%)
Escherichia Infection
22 (.27%)
Ovarian Cyst
22 (.27%)
Pyelonephritis
22 (.27%)
Renal Tubular Necrosis
22 (.27%)
Acute Hepatic Failure
21 (.26%)
Cachexia
21 (.26%)
Fatigue
21 (.26%)
Immunosuppressant Drug Level Increa...
21 (.26%)
Interstitial Lung Disease
21 (.26%)
Liver Function Test Abnormal
21 (.26%)
Pharyngitis
21 (.26%)
Prostate Cancer
21 (.26%)
Bk Virus Infection
20 (.25%)
Complications Of Transplant Surgery
20 (.25%)
Pulmonary Embolism
20 (.25%)
Pyelonephritis Acute
20 (.25%)
Cardiac Arrest
19 (.24%)
Cellulitis
19 (.24%)
Chills
19 (.24%)
Hepatic Encephalopathy
19 (.24%)
Oedema
19 (.24%)
Pancytopenia
19 (.24%)
Pericardial Effusion
19 (.24%)
Urosepsis
19 (.24%)
White Blood Cell Count Decreased
19 (.24%)
Kidney Fibrosis
18 (.22%)
Photosensitivity Reaction
18 (.22%)
Thrombosis
18 (.22%)
Venoocclusive Disease
18 (.22%)
Wound Dehiscence
18 (.22%)

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This graph shows the top adverse events submitted to the FDA for Sirolimus, 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 Sirolimus 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 Sirolimus

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

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This graph shows the top categories of adverse events submitted to the FDA for Sirolimus, 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 Sirolimus 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 Sirolimus According to Those Reporting Adverse Events

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

Prophylaxis Against Transplant Reje...
795
Immunosuppression
309
Renal Transplant
160
Immunosuppressant Drug Therapy
134
Prophylaxis Against Graft Versus Ho...
57
Graft Versus Host Disease
39
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Liver Transplant
34
Heart Transplant
29
Drug Use For Unknown Indication
21
Product Used For Unknown Indication
19
Lung Transplant
18
Kidney Transplant Rejection
15
Chronic Allograft Nephropathy
15
Prophylaxis
11
Stem Cell Transplant
10
Neurofibromatosis
10
Renal Cell Carcinoma
9
Renal Impairment
9
Renal And Pancreas Transplant
7
Chronic Graft Versus Host Disease
7
Acute Lymphocytic Leukaemia
6
Basal Cell Carcinoma
6
Coronary Arterial Stent Insertion
6
Liver Transplant Rejection
6
Histoplasmosis
6
Small Intestine Transplant
5
Transplant Rejection
5
Percutaneous Coronary Intervention
4
Organ Transplant
4
Neoplasm Prophylaxis
4
Glioblastoma Multiforme
4
Bone Marrow Transplant
4
Multiple Myeloma
4
Congenital Cystic Kidney Disease
4
Transplant
4
Scleroderma
4
Coronary Artery Disease
4
Proteinuria
3
Kaposis Sarcoma
3
Ill-defined Disorder
3
Renal Disorder
3
Coronary Artery Stenosis
3
Pancreas Islet Cell Transplant
3
Stent Placement
3
Rheumatoid Arthritis
3
Neurofibroma
3
Uveitis
3
Coronary Artery Occlusion
3
Blastomycosis
2
Dermatitis Exfoliative
2
Intestinal Transplant
2

Drug Labels

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

Sirolimus Case Reports

What Sirolimus 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 Sirolimus. 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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