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SANDIMMUNE

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Sandimmune Adverse Events Reported to the FDA Over Time

How are Sandimmune adverse event reports trending over time?

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

Most Common Sandimmune Adverse Events Reported to the FDA

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

Pyrexia
313 (1.94%)
Blood Creatinine Increased
262 (1.63%)
Renal Impairment
164 (1.02%)
Diarrhoea
153 (.95%)
Dyspnoea
151 (.94%)
Renal Failure
148 (.92%)
Pneumonia
137 (.85%)
Vomiting
125 (.78%)
Sepsis
122 (.76%)
Hypertension
113 (.7%)
Blood Bilirubin Increased
109 (.68%)
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Renal Failure Acute
108 (.67%)
Cytomegalovirus Infection
106 (.66%)
Graft Versus Host Disease
105 (.65%)
Respiratory Failure
104 (.65%)
Multi-organ Failure
101 (.63%)
Alanine Aminotransferase Increased
95 (.59%)
Headache
95 (.59%)
Rash
95 (.59%)
Depressed Level Of Consciousness
93 (.58%)
Aspartate Aminotransferase Increase...
87 (.54%)
Abdominal Pain
84 (.52%)
Nausea
84 (.52%)
Drug Interaction
77 (.48%)
Thrombotic Microangiopathy
74 (.46%)
Blood Urea Increased
73 (.45%)
Convulsion
73 (.45%)
Cough
70 (.43%)
Nephropathy Toxic
70 (.43%)
Pancytopenia
69 (.43%)
Blood Lactate Dehydrogenase Increas...
67 (.42%)
C-reactive Protein Increased
65 (.4%)
Somnolence
65 (.4%)
Blood Pressure Increased
64 (.4%)
Leukopenia
64 (.4%)
Immunosuppressant Drug Level Increa...
63 (.39%)
Gamma-glutamyltransferase Increased
61 (.38%)
Kidney Transplant Rejection
61 (.38%)
General Physical Health Deteriorati...
60 (.37%)
Oedema Peripheral
60 (.37%)
Complications Of Transplanted Kidne...
58 (.36%)
Hypotension
58 (.36%)
Urinary Tract Infection
58 (.36%)
Confusional State
57 (.35%)
Drug Level Increased
55 (.34%)
Jaundice
55 (.34%)
Blood Creatine Phosphokinase Increa...
54 (.34%)
Disease Progression
53 (.33%)
Tachycardia
53 (.33%)
Infection
52 (.32%)
Rhabdomyolysis
51 (.32%)
Death
50 (.31%)
Myalgia
50 (.31%)
Renal Disorder
50 (.31%)
Cardiac Failure
49 (.3%)
Arthralgia
48 (.3%)
Haemoglobin Decreased
48 (.3%)
Lymphocele
48 (.3%)
Pain
48 (.3%)
Surgery
48 (.3%)
Weight Increased
48 (.3%)
Hepatic Enzyme Increased
47 (.29%)
Histiocytosis Haematophagic
47 (.29%)
Mechanical Ventilation
47 (.29%)
Thrombocytopenia
47 (.29%)
Blood Alkaline Phosphatase Increase...
46 (.29%)
Cholestasis
46 (.29%)
Drug Ineffective
46 (.29%)
Platelet Count Decreased
46 (.29%)
Pneumocystis Jiroveci Pneumonia
45 (.28%)
Abdominal Pain Upper
44 (.27%)
White Blood Cell Count Decreased
44 (.27%)
Asthenia
43 (.27%)
Interstitial Lung Disease
43 (.27%)
Malaise
43 (.27%)
Anuria
42 (.26%)
Neutropenia
42 (.26%)
Pruritus
42 (.26%)
Visual Impairment
42 (.26%)
Chills
41 (.25%)
Fatigue
41 (.25%)
Gait Disturbance
41 (.25%)
Gastrointestinal Haemorrhage
41 (.25%)
Pleural Effusion
41 (.25%)
Tremor
41 (.25%)
Anaemia
40 (.25%)
Liver Disorder
40 (.25%)
Pain In Extremity
40 (.25%)
Proteinuria
40 (.25%)
Coma
39 (.24%)
Oxygen Saturation Decreased
39 (.24%)
Ascites
38 (.24%)
Renal Tubular Necrosis
38 (.24%)
Aspergillosis
37 (.23%)
Visual Acuity Reduced
37 (.23%)
Dehydration
36 (.22%)
Disseminated Intravascular Coagulat...
36 (.22%)
Hyperkalaemia
36 (.22%)
Oedema
36 (.22%)
Drug Level Decreased
35 (.22%)
Haemodialysis
35 (.22%)

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

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

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

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

Renal Transplant
814
Heart Transplant
144
Liver Transplant
127
Bone Marrow Transplant
111
Stem Cell Transplant
110
Prophylaxis Against Graft Versus Ho...
93
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Psoriasis
80
Immunosuppression
75
Lung Transplant
73
Cord Blood Transplant Therapy
70
Aplastic Anaemia
66
Colitis Ulcerative
65
Rheumatoid Arthritis
51
Prophylaxis Against Transplant Reje...
51
Graft Versus Host Disease
49
Drug Use For Unknown Indication
42
Product Used For Unknown Indication
35
Nephrotic Syndrome
33
Juvenile Arthritis
30
Transplant
26
Prophylaxis
24
Dermatitis Atopic
21
Allogenic Bone Marrow Transplantati...
19
Dermatomyositis
15
Uveitis
13
Behcets Syndrome
12
Histiocytosis Haematophagic
12
Corneal Transplant
12
Pyoderma Gangrenosum
11
Systemic Lupus Erythematosus
11
Glomerulonephritis
10
Pustular Psoriasis
10
Transplant Rejection
10
Immunosuppressant Drug Therapy
9
Eczema
8
Myelodysplastic Syndrome
8
Interstitial Lung Disease
7
Psoriatic Arthropathy
7
Autoimmune Hepatitis
7
Hepatitis B
7
Colitis
6
Autoimmune Disorder
6
Asthma
6
Renal And Pancreas Transplant
6
Crohns Disease
5
Focal Glomerulosclerosis
5
Chronic Graft Versus Host Disease
5
Vasculitis
4
Blepharitis
4
Aplasia
4
Large Granular Lymphocytosis
4

Drug Labels

LabelLabelerEffective
SandimmuneNovartis Pharmaceuticals Corporation07-SEP-12

Sandimmune Case Reports

What Sandimmune 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 Sandimmune. 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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