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Kepivance Adverse Events Reported to the FDA Over Time

How are Kepivance adverse event reports trending over time?

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

Most Common Kepivance Adverse Events Reported to the FDA

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

Rash
45 (3.99%)
Diarrhoea
41 (3.63%)
Pyrexia
37 (3.28%)
Mucosal Inflammation
36 (3.19%)
Erythema
28 (2.48%)
Respiratory Failure
28 (2.48%)
Lung Infiltration
25 (2.22%)
Hypotension
24 (2.13%)
Face Oedema
22 (1.95%)
Pneumonia
21 (1.86%)
Stomatitis
19 (1.68%)
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Vomiting
19 (1.68%)
Oedema Peripheral
18 (1.6%)
Pruritus
18 (1.6%)
Dysgeusia
16 (1.42%)
Tongue Disorder
15 (1.33%)
Sepsis
14 (1.24%)
Fluid Retention
13 (1.15%)
Skin Exfoliation
12 (1.06%)
Anorexia
11 (.98%)
Capillary Leak Syndrome
11 (.98%)
Toxic Skin Eruption
10 (.89%)
Weight Increased
10 (.89%)
Blister
9 (.8%)
Clostridial Infection
9 (.8%)
Febrile Neutropenia
9 (.8%)
Neutropenia
9 (.8%)
Oedema
9 (.8%)
Skin Discolouration
9 (.8%)
Swollen Tongue
9 (.8%)
Convulsion
8 (.71%)
Nausea
8 (.71%)
Rash Maculo-papular
8 (.71%)
Acute Respiratory Distress Syndrome
7 (.62%)
Infection
7 (.62%)
Neutropenic Colitis
7 (.62%)
Rash Erythematous
7 (.62%)
Renal Failure
7 (.62%)
Salivary Hypersecretion
7 (.62%)
Skin Reaction
7 (.62%)
Thrombocytopenia
7 (.62%)
Bone Marrow Failure
6 (.53%)
Dyspnoea
6 (.53%)
Enterococcal Bacteraemia
6 (.53%)
Gastrointestinal Inflammation
6 (.53%)
Gastrointestinal Necrosis
6 (.53%)
Graft Versus Host Disease
6 (.53%)
Oesophagitis
6 (.53%)
Pain
6 (.53%)
Pancytopenia
6 (.53%)
Stem Cell Transplant
6 (.53%)
Aplasia
5 (.44%)
Cardiac Failure
5 (.44%)
Chills
5 (.44%)
Circulatory Collapse
5 (.44%)
Drug Eruption
5 (.44%)
Drug Ineffective
5 (.44%)
Dysaesthesia
5 (.44%)
Fatigue
5 (.44%)
Periorbital Oedema
5 (.44%)
Pulmonary Congestion
5 (.44%)
Skin Hyperpigmentation
5 (.44%)
Burning Sensation
4 (.35%)
Cardiac Disorder
4 (.35%)
Cytomegalovirus Antigen Positive
4 (.35%)
Death
4 (.35%)
Delayed Engraftment
4 (.35%)
Dermatitis Exfoliative
4 (.35%)
Dialysis
4 (.35%)
Drug Interaction
4 (.35%)
Epidermolysis
4 (.35%)
Gait Disturbance
4 (.35%)
Hypersensitivity
4 (.35%)
Impaired Healing
4 (.35%)
International Normalised Ratio Incr...
4 (.35%)
Jaundice
4 (.35%)
Leukopenia
4 (.35%)
Lung Injury
4 (.35%)
Mouth Haemorrhage
4 (.35%)
Oral Mucosal Discolouration
4 (.35%)
Paraesthesia Oral
4 (.35%)
Pneumatosis Intestinalis
4 (.35%)
Pulmonary Fibrosis
4 (.35%)
Rash Papular
4 (.35%)
Staphylococcal Sepsis
4 (.35%)
Tongue Oedema
4 (.35%)
Venoocclusive Disease
4 (.35%)
Acute Pulmonary Oedema
3 (.27%)
Anaemia
3 (.27%)
Blood Bilirubin Increased
3 (.27%)
Cardiogenic Shock
3 (.27%)
Condition Aggravated
3 (.27%)
Dysphagia
3 (.27%)
Eyelid Oedema
3 (.27%)
Fluid Overload
3 (.27%)
Gamma-glutamyltransferase Increased
3 (.27%)
Gastritis
3 (.27%)
General Physical Health Deteriorati...
3 (.27%)
Generalised Erythema
3 (.27%)
Generalised Oedema
3 (.27%)
Hypertension
3 (.27%)

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

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

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

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

Mucosal Inflammation
118
Drug Use For Unknown Indication
41
Stomatitis
25
Bone Marrow Transplant
8
Prophylaxis
7
Autoimmune Disorder
6
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Peripheral Blood Stem Cell Apheresi...
6
Chemotherapy
4
Pre-existing Disease
3
Product Used For Unknown Indication
2
Allogenic Bone Marrow Transplantati...
2
Stem Cell Transplant
1
Immunodeficiency Congenital
1
Acute Myeloid Leukaemia
1

Drug Labels

LabelLabelerEffective
KepivanceSwedish Orphan Biovitrum AB (publ)27-SEP-11

Kepivance Case Reports

What Kepivance 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 Kepivance. 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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