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Jakafi Adverse Events Reported to the FDA Over Time

How are Jakafi adverse event reports trending over time?

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

Most Common Jakafi Adverse Events Reported to the FDA

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

Death
106 (10.95%)
Anaemia
29 (3%)
Fatigue
26 (2.69%)
Hospitalisation
24 (2.48%)
Dyspnoea
23 (2.38%)
Platelet Count Decreased
21 (2.17%)
Fall
18 (1.86%)
Haemoglobin Decreased
18 (1.86%)
Headache
18 (1.86%)
Pneumonia
17 (1.76%)
Pancytopenia
16 (1.65%)
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Epistaxis
15 (1.55%)
Cerebrovascular Accident
13 (1.34%)
Abdominal Pain
12 (1.24%)
Diarrhoea
12 (1.24%)
Pyrexia
11 (1.14%)
Dehydration
10 (1.03%)
Thrombocytopenia
10 (1.03%)
Urinary Tract Infection
10 (1.03%)
Asthenia
9 (.93%)
Haematoma
9 (.93%)
White Blood Cell Count Increased
9 (.93%)
Disease Progression
8 (.83%)
Drug Ineffective
8 (.83%)
General Physical Health Deteriorati...
8 (.83%)
Nausea
8 (.83%)
Acute Leukaemia
7 (.72%)
Decreased Appetite
7 (.72%)
Atrial Fibrillation
6 (.62%)
Chest Pain
6 (.62%)
Chromaturia
6 (.62%)
Malaise
6 (.62%)
Oedema
6 (.62%)
Back Pain
5 (.52%)
Blood Pressure Increased
5 (.52%)
Chest Discomfort
5 (.52%)
Dizziness
5 (.52%)
Faeces Discoloured
5 (.52%)
Haemorrhage
5 (.52%)
Hypotension
5 (.52%)
Meningitis Cryptococcal
5 (.52%)
Mouth Haemorrhage
5 (.52%)
Pleural Effusion
5 (.52%)
Renal Failure
5 (.52%)
Splenectomy
5 (.52%)
Splenomegaly
5 (.52%)
Staphylococcal Infection
5 (.52%)
Vomiting
5 (.52%)
Weight Decreased
5 (.52%)
Abnormal Faeces
4 (.41%)
Alopecia
4 (.41%)
Blood Creatinine Increased
4 (.41%)
Blood Iron Increased
4 (.41%)
Faecal Incontinence
4 (.41%)
Feeling Abnormal
4 (.41%)
Full Blood Count Decreased
4 (.41%)
Hepatic Encephalopathy
4 (.41%)
Hepatic Enzyme Increased
4 (.41%)
Hepatic Failure
4 (.41%)
Limb Injury
4 (.41%)
Myelofibrosis
4 (.41%)
Neuropathy Peripheral
4 (.41%)
Optic Nerve Injury
4 (.41%)
Oropharyngeal Pain
4 (.41%)
Pain In Extremity
4 (.41%)
Rash Macular
4 (.41%)
Transfusion
4 (.41%)
Urinary Incontinence
4 (.41%)
Withdrawal Syndrome
4 (.41%)
Abdominal Pain Upper
3 (.31%)
Ammonia Increased
3 (.31%)
Blood Count Abnormal
3 (.31%)
Cardiomyopathy
3 (.31%)
Confusional State
3 (.31%)
Deep Vein Thrombosis
3 (.31%)
Gait Disturbance
3 (.31%)
Gastrointestinal Haemorrhage
3 (.31%)
Haemoptysis
3 (.31%)
Hepatomegaly
3 (.31%)
Muscle Strain
3 (.31%)
Nephrolithiasis
3 (.31%)
Pericardial Effusion
3 (.31%)
Renal Failure Acute
3 (.31%)
Sepsis
3 (.31%)
Septic Shock
3 (.31%)
Surgery
3 (.31%)
Thrombosis
3 (.31%)
Treatment Noncompliance
3 (.31%)
Acute Myeloid Leukaemia
2 (.21%)
Adverse Event
2 (.21%)
Ascites
2 (.21%)
Aspiration Pleural Cavity
2 (.21%)
Bacteriuria
2 (.21%)
Blood Albumin Decreased
2 (.21%)
Blood Bilirubin Increased
2 (.21%)
Blood Glucose Increased
2 (.21%)
Blood Iron Decreased
2 (.21%)
Blood Lactate Dehydrogenase Abnorma...
2 (.21%)
Blood Product Transfusion Dependent
2 (.21%)
Bone Marrow Failure
2 (.21%)
Bradycardia
2 (.21%)

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

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

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

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

Myelofibrosis
278
Polycythaemia Vera
9
Myeloproliferative Disorder
3
Budd-chiari Syndrome
3
Myeloid Metaplasia
3
Splenomegaly
3
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Liposarcoma
2
Neoplasm Malignant
2
Product Used For Unknown Indication
2
Lymphatic Disorder
2
Polycythaemia
1
Pancreatic Carcinoma
1
Chronic Lymphocytic Leukaemia
1
Lymphoproliferative Disorder
1
Blood Disorder
1
Bone Marrow Failure
1
Sarcoma
1
Pulmonary Hypertension
1

Drug Labels

LabelLabelerEffective
JakafiIncyte Corporation22-JUN-12

Jakafi Case Reports

What Jakafi 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 Jakafi. 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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