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Daptomycin Adverse Events Reported to the FDA Over Time

How are Daptomycin adverse event reports trending over time?

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

Most Common Daptomycin Adverse Events Reported to the FDA

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

Blood Creatine Phosphokinase Increa...
54 (5.25%)
Rhabdomyolysis
52 (5.05%)
Dyspnoea
26 (2.53%)
Eosinophilic Pneumonia
24 (2.33%)
Drug Interaction
21 (2.04%)
Pyrexia
21 (2.04%)
Blood Creatinine Increased
17 (1.65%)
Eosinophilia
14 (1.36%)
Infection
13 (1.26%)
Pneumonia
13 (1.26%)
Rash
13 (1.26%)
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Oedema Peripheral
12 (1.17%)
Renal Failure
12 (1.17%)
Renal Failure Acute
12 (1.17%)
Atrial Fibrillation
11 (1.07%)
Anaphylactic Shock
10 (.97%)
Drug Eruption
10 (.97%)
Pneumonitis
10 (.97%)
Cardiac Arrest
9 (.87%)
Pruritus
9 (.87%)
Eosinophil Count Increased
8 (.78%)
Fatigue
8 (.78%)
Impaired Healing
8 (.78%)
Lower Respiratory Tract Infection
8 (.78%)
Lung Infiltration
8 (.78%)
Myalgia
8 (.78%)
Pain
8 (.78%)
Acute Generalised Exanthematous Pus...
7 (.68%)
C-reactive Protein Increased
7 (.68%)
Haemodialysis
7 (.68%)
Multi-organ Failure
7 (.68%)
Thrombocytopenia
7 (.68%)
Acute Hepatic Failure
6 (.58%)
Arthralgia
6 (.58%)
Aspartate Aminotransferase Increase...
6 (.58%)
Blood Potassium Increased
6 (.58%)
Cardiovascular Insufficiency
6 (.58%)
Diarrhoea
6 (.58%)
Drug Rash With Eosinophilia And Sys...
6 (.58%)
Fall
6 (.58%)
Haemorrhage
6 (.58%)
Nausea
6 (.58%)
Potentiating Drug Interaction
6 (.58%)
White Blood Cell Count Increased
6 (.58%)
Asthenia
5 (.49%)
Back Pain
5 (.49%)
Cough
5 (.49%)
Depression
5 (.49%)
Drug Hypersensitivity
5 (.49%)
Pain In Extremity
5 (.49%)
Respiratory Distress
5 (.49%)
Stevens-johnson Syndrome
5 (.49%)
Abdominal Distension
4 (.39%)
Alanine Aminotransferase Increased
4 (.39%)
Alveolitis Allergic
4 (.39%)
Dialysis
4 (.39%)
Dysstasia
4 (.39%)
Ecchymosis
4 (.39%)
Gastroenteritis Clostridial
4 (.39%)
General Physical Health Deteriorati...
4 (.39%)
Hepatic Cirrhosis
4 (.39%)
Hepatic Enzyme Increased
4 (.39%)
Liver Function Test Abnormal
4 (.39%)
Malaise
4 (.39%)
Megacolon
4 (.39%)
Mental Status Changes
4 (.39%)
Nerve Injury
4 (.39%)
Pleural Effusion
4 (.39%)
Postoperative Thoracic Procedure Co...
4 (.39%)
Rash Macular
4 (.39%)
Renal Impairment
4 (.39%)
Respiratory Failure
4 (.39%)
Septic Shock
4 (.39%)
Unresponsive To Stimuli
4 (.39%)
Agitation
3 (.29%)
Anaphylactic Reaction
3 (.29%)
Bacteraemia
3 (.29%)
Cardiac Failure Congestive
3 (.29%)
Chills
3 (.29%)
Cholestasis
3 (.29%)
Confusional State
3 (.29%)
Cytomegalovirus Viraemia
3 (.29%)
Deafness
3 (.29%)
Death
3 (.29%)
Decreased Appetite
3 (.29%)
Dermatitis Bullous
3 (.29%)
Enterococcal Infection
3 (.29%)
Erythema
3 (.29%)
Febrile Neutropenia
3 (.29%)
Fungal Infection
3 (.29%)
Haematocrit Decreased
3 (.29%)
Hypoxia
3 (.29%)
Infusion Related Reaction
3 (.29%)
Interstitial Lung Disease
3 (.29%)
Lethargy
3 (.29%)
Leukopenia
3 (.29%)
Lymphadenopathy
3 (.29%)
Muscular Weakness
3 (.29%)
Myositis
3 (.29%)
Platelet Count Decreased
3 (.29%)
Rash Generalised
3 (.29%)

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

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

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

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

Product Used For Unknown Indication
50
Staphylococcal Infection
33
Drug Use For Unknown Indication
31
Osteomyelitis
24
Infection
21
Endocarditis
17
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Bacteraemia
17
Cellulitis
16
Staphylococcal Bacteraemia
15
Enterococcal Infection
14
Endocarditis Bacterial
14
Arthritis Bacterial
11
Infection Prophylaxis
11
Arthropathy
10
Arthritis Infective
9
Endocarditis Staphylococcal
6
Staphylococcal Osteomyelitis
6
Staphylococcal Abscess
6
Enterococcal Bacteraemia
6
Device Related Infection
6
Soft Tissue Infection
5
Cellulitis Staphylococcal
5
Sepsis
5
Wound Infection
4
Staphylococcal Sepsis
4
Post Procedural Infection
4
Antibiotic Therapy
4
Abscess
4
Endocarditis Enterococcal
4
Abdominal Infection
3
Postoperative Infection
3
Drug Hypersensitivity
3
Staphylococcal Mediastinitis
3
Inflammation
2
Spinal Disorder
2
Localised Infection
2
Bacterial Infection
2
Abdominal Abscess
2
Extradural Abscess
2
Bursitis Infective
2
Febrile Neutropenia
2
Evidence Based Treatment
2
Skin Reaction
2
Liver Abscess
2
Wound Infection Staphylococcal
2
Postoperative Wound Infection
2
Pseudomonas Infection
2
Skin Infection
2
Necrotising Fasciitis
2
Osteomyelitis Chronic
2
Pericarditis
1

Drug Labels

LabelLabelerEffective
CubicinCubist Pharmaceuticals, Inc.10-APR-13

Daptomycin Case Reports

What Daptomycin 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 Daptomycin. 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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