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IPILIMUMAB

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Ipilimumab Adverse Events Reported to the FDA Over Time

How are Ipilimumab adverse event reports trending over time?

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

Most Common Ipilimumab Adverse Events Reported to the FDA

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

Diarrhoea
313 (5.36%)
Colitis
227 (3.88%)
Neoplasm Malignant
209 (3.58%)
Dehydration
175 (3%)
Pyrexia
165 (2.82%)
Vomiting
153 (2.62%)
Nausea
137 (2.34%)
Fatigue
113 (1.93%)
Abdominal Pain
92 (1.57%)
Decreased Appetite
82 (1.4%)
Dyspnoea
79 (1.35%)
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Hyponatraemia
75 (1.28%)
Headache
73 (1.25%)
Alanine Aminotransferase Increased
71 (1.22%)
Anaemia
71 (1.22%)
Sepsis
70 (1.2%)
Aspartate Aminotransferase Increase...
68 (1.16%)
Pain
66 (1.13%)
Renal Failure Acute
63 (1.08%)
Hypotension
62 (1.06%)
Muscular Weakness
53 (.91%)
Adrenal Insufficiency
52 (.89%)
Pneumonia
52 (.89%)
Hypophysitis
49 (.84%)
Large Intestine Perforation
45 (.77%)
Death
44 (.75%)
Confusional State
43 (.74%)
Pulmonary Embolism
42 (.72%)
Thrombocytopenia
39 (.67%)
Rash
37 (.63%)
Urinary Tract Infection
36 (.62%)
Rash Maculo-papular
34 (.58%)
Atrial Fibrillation
32 (.55%)
Blood Alkaline Phosphatase Increase...
32 (.55%)
Lipase Increased
32 (.55%)
Multi-organ Failure
30 (.51%)
Asthenia
29 (.5%)
Respiratory Failure
29 (.5%)
Blood Bilirubin Increased
27 (.46%)
Hypoalbuminaemia
27 (.46%)
Renal Failure
27 (.46%)
Hypokalaemia
26 (.44%)
Platelet Count Decreased
26 (.44%)
Back Pain
25 (.43%)
Chills
25 (.43%)
Intestinal Perforation
25 (.43%)
Lung Infection
25 (.43%)
Autoimmune Hepatitis
24 (.41%)
Gastrointestinal Haemorrhage
24 (.41%)
Syncope
24 (.41%)
Weight Decreased
24 (.41%)
General Physical Health Deteriorati...
23 (.39%)
Neoplasm Progression
23 (.39%)
Neutrophil Count Decreased
23 (.39%)
Arthralgia
22 (.38%)
Constipation
22 (.38%)
Metastatic Malignant Melanoma
21 (.36%)
Oedema Peripheral
21 (.36%)
Transaminases Increased
21 (.36%)
Abdominal Pain Upper
20 (.34%)
Lethargy
20 (.34%)
Mental Status Changes
20 (.34%)
Hepatic Failure
19 (.33%)
Metastases To Central Nervous Syste...
19 (.33%)
Convulsion
18 (.31%)
Cough
18 (.31%)
Enterocolitis
18 (.31%)
Pleural Effusion
18 (.31%)
Tachycardia
17 (.29%)
Arthritis
16 (.27%)
Deep Vein Thrombosis
16 (.27%)
Embolism
16 (.27%)
Fall
16 (.27%)
Hypoglycaemia
16 (.27%)
Hypothyroidism
16 (.27%)
Malignant Melanoma
16 (.27%)
Pain In Extremity
16 (.27%)
Pneumonitis
16 (.27%)
Pruritus
16 (.27%)
Blood Creatinine Increased
15 (.26%)
Dysphagia
15 (.26%)
Hypercalcaemia
15 (.26%)
Ileus
15 (.26%)
Pancreatitis
15 (.26%)
Cytolytic Hepatitis
14 (.24%)
Emotional Distress
14 (.24%)
Hepatitis
14 (.24%)
Malignant Neoplasm Progression
14 (.24%)
Staphylococcal Infection
14 (.24%)
Venous Thrombosis
14 (.24%)
Dizziness
13 (.22%)
Hyperthermia
13 (.22%)
Large Intestinal Haemorrhage
13 (.22%)
Malaise
13 (.22%)
Myalgia
13 (.22%)
Depression
12 (.21%)
Haemoglobin Decreased
12 (.21%)
Hyperkalaemia
12 (.21%)
Hypertension
12 (.21%)
Small Intestinal Obstruction
12 (.21%)
Spinal Cord Compression
12 (.21%)

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

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

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

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

Malignant Melanoma
1272
Metastatic Malignant Melanoma
117
Lung Neoplasm Malignant
29
Prostate Cancer
26
Small Cell Lung Cancer Stage Unspec...
17
Non-small Cell Lung Cancer
13
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Bone Sarcoma
7
Prostate Cancer Metastatic
7
Neoplasm
4
Hodgkins Disease
4
Neoplasm Malignant
2
Adenocarcinoma Pancreas
2
Sarcoma
2
Product Used For Unknown Indication
1
Malignant Melanoma Stage Iv
1
Metastasis
1
Colitis
1

Drug Labels

LabelLabelerEffective
YervoyE.R. Squibb & Sons, L.L.C.20-NOV-12

Ipilimumab Case Reports

What Ipilimumab 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 Ipilimumab. 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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