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Daptomycin Side Effects

Common Daptomycin Side Effects


The most commonly reported Daptomycin side effects (click to view or check a box to report):

Blood Creatine Phosphokinase Increased (52)
Rhabdomyolysis (37)
Eosinophilic Pneumonia (34)
Pyrexia (18)
Dyspnoea (17)
Rash (11)
Myalgia (11)
Eosinophilia (11)
Renal Failure Acute (10)
Blood Creatinine Increased (9)
Lung Infiltration (8)
Pruritus (8)
Pain (6)
Pneumonitis (6)
Nausea (6)
Respiratory Distress (6)
Infection (6)
Aspartate Aminotransferase Increased (6)
Eosinophil Count Increased (6)
Renal Failure (6)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Daptomycin Side Effects Reported to FDA

The following Daptomycin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Daptomycin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Necrotising Fasciitis, Staphylococcal Infection, Limb Discomfort, Joint Swelling, Chest Pain, Staphylococcal Sepsis
This is a report of a male patient (weight: NA) from GB, suffering from the following symptoms/conditions: endocarditis staphylococcal,off label use, who was treated with Daptomycin (dosage: 8 Mg/kg, Daily, start time: Nov 17, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Necrotising Fasciitis
  • Staphylococcal Infection
  • Limb Discomfort
  • Joint Swelling
  • Chest Pain
  • Staphylococcal Sepsis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Daptomycin treatment in male patients, resulting in necrotising fasciitis side effect. The patient was hospitalized.

Osteomyelitis, Pneumonia
This report suggests a potential Daptomycin Osteomyelitis, Pneumonia side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: decubitus ulcer and used Daptomycin (dosage: NA) starting Sep 30, 2013. Soon after starting Daptomycin the patient began experiencing various side effects, including:
  • Osteomyelitis
  • Pneumonia
Drugs used concurrently:
  • Imipenem
The patient was hospitalized. Although Daptomycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as osteomyelitis, may still occur.

Blood Creatine Phosphokinase Increased, Myalgia
This Blood Creatine Phosphokinase Increased, Myalgia problem was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteomyelitis. On NS this consumer started treatment with Daptomycin (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Daptomycin, the patient experienced the following unwanted symptoms/side effects:
  • Blood Creatine Phosphokinase Increased
  • Myalgia
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood creatine phosphokinase increased, may become evident only after a product is in use by the general population.

Diabetes Mellitus Inadequate Control, Oliguria
This is a report of a 64-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Daptomycin (dosage: NA) starting Aug 16, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Diabetes Mellitus Inadequate Control
  • Oliguria
The patient was hospitalized. This opens a possibility that Daptomycin treatment could cause the above reactions, including diabetes mellitus inadequate control, and some male subjects may be more susceptible.


Necrotising Fasciitis
A 69-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Daptomycin treatment (dosage: NA) on May 08, 2013. Soon after starting Daptomycin treatment, the subject experienced various side effects, including:
  • Necrotising Fasciitis
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Daptomycin.

Renal Failure Acute, Hepatitis Acute, Rhabdomyolysis, Haemodialysis
A 64-year-old female patient from US (weight: NA) experienced symptoms, such as: arthritis bacterial,staphylococcal infection and was treated with Daptomycin(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Renal Failure Acute
  • Hepatitis Acute
  • Rhabdomyolysis
  • Haemodialysis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Daptomycin efficacy: NA.The patient was hospitalized.

Pyrexia, Mental Status Changes, Dyspnoea, Traumatic Lung Injury, Lung Infiltration
In this report, Daptomycin (cubicin) was administered for the following condition: osteomyelitis.A 76-year-old male consumer from US (weight: NA) started Daptomycin (cubicin) treatment (dosage: NA) on Nov 14, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pyrexia
  • Mental Status Changes
  • Dyspnoea
  • Traumatic Lung Injury
  • Lung Infiltration
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Daptomycin (cubicin) treatment could be related to the listed above side effect(s).

Rhabdomyolysis
This is a report of the following Daptomycin side effect(s):
  • Rhabdomyolysis
A 63-year-old male patient from US (weight: NA) presented with the following condition: infection and received a treatment with Daptomycin (dosage: 900 Mg, Other, Iv) starting: Apr 04, 2013.The following concurrently used drugs could have generated interactions:
  • Atorvastatin (10 Mg, Every Day, Po)
The patient was hospitalized.This report suggests that a Daptomycin treatment could be associated with the listed above side effect(s).

Blood Creatine Phosphokinase Increased
This Daptomycin (cubicin) report was submitted by a 64-year-old female consumer from US (weight: NA). The patient was diagnosed with: abdominal abscess and Daptomycin (cubicin) was administered (dosage: NA) starting: Oct 23, 2013. The consumer developed a set of symptoms:
  • Blood Creatine Phosphokinase Increased
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Daptomycin (cubicin) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Respiratory Distress, Blood Creatinine Increased
This is a report of a possible correlation between Daptomycin use and the following symptoms/side effect(s):
  • Respiratory Distress
  • Blood Creatinine Increased
which could contribute to an assessment of Daptomycin risk profile.A 35-year-old male consumer from US (weight: NA) was suffering from diabetic foot,osteomyelitis and was treated with Daptomycin (dosage: NA) starting Oct 15, 2013.Other concurrent medications: NA.The patient was hospitalized.

Blood Creatine Phosphokinase Increased
A 60-year-old female patient from US (weight: NA) presented with the following symptoms: staphylococcal bacteraemia and after a treatment with Daptomycin (dosage: NA) experienced the following side effect(s):
  • Blood Creatine Phosphokinase Increased
The treatment was started on Oct 22, 2013. Daptomycin was used in combination with the following drugs:
  • Linezolid
  • Merrem
  • Flagyl
  • Micafungin
  • Oxacillin
  • Zosyn
  • Rifampin
  • Tygacil
This report could alert potential Daptomycin consumers.

Pruritus, Infusion Site Pruritus, Infusion Site Urticaria
In this report, a 22-year-old male patient from US (weight: NA) was affected by a possible Daptomycin side effect.The patient was diagnosed with localised infection. After a treatment with Daptomycin (dosage: NA, start date: Sep 30, 2013), the patient experienced the following side effect(s):
  • Pruritus
  • Infusion Site Pruritus
  • Infusion Site Urticaria
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Daptomycin treatment.

Blood Creatine Phosphokinase Increased
This is a report of a 54-year-old male patient from US (weight: NA), who used Daptomycin (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Blood Creatine Phosphokinase Increased
The following drugs could possibly have interacted with the Daptomycin treatment NA.Taken together, these observations suggest that a Daptomycin treatment could be related to side effect(s), such as Blood Creatine Phosphokinase Increased.

Blood Creatine Phosphokinase Abnormal
This blood creatine phosphokinase abnormal side effect was reported by a pharmacist from US. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: sepsis. The patient was prescribed Daptomycin (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Daptomycin the consumer reported the following symptoms:
  • Blood Creatine Phosphokinase Abnormal
These side effects may potentially be related to Daptomycin.

Erythema Multiforme
This is a Daptomycin side effect report of a 80-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: cellulitis, who was treated with Daptomycin (dosage:NA, start time: Aug 20, 2013), combined with: NA., and developed a serious reaction and a erythema multiforme side effect. The patient presented with:
  • Erythema Multiforme
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Daptomycin treatment in female patients suffering from cellulitis, resulting in erythema multiforme.

Tendon Rupture, Muscle Spasms
This report suggests a potential Daptomycin tendon rupture side effect(s) that can have serious consequences. A 57-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): post procedural infection and used Daptomycin (dosage: NA) starting Jul 01, 2013. Soon after starting Daptomycin the patient began experiencing various side effects, including:
  • Tendon Rupture
  • Muscle Spasms
Drugs used concurrently:
  • Rocephin
Although Daptomycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as tendon rupture, may still occur.

Eosinophilic Pneumonia Acute, Respiratory Failure, Wound Infection Bacterial, Klebsiella Infection, Escherichia Infection
This eosinophilic pneumonia acute problem was reported by a pharmacist from US. A 53-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): endocarditis staphylococcal.On Aug 23, 2013 a consumer started treatment with Daptomycin (dosage: NA). The following drugs/medications were being taken at the same time:
  • Ceftaroline
When commencing Daptomycin, the patient experienced the following unwanted symptoms /side effects:
  • Eosinophilic Pneumonia Acute
  • Respiratory Failure
  • Wound Infection Bacterial
  • Klebsiella Infection
  • Escherichia Infection
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as eosinophilic pneumonia acute, may become evident only after a product is in use by the general population.

Liver Function Test Abnormal
This is a Daptomycin side effect report of a 31-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: osteomyelitis and was treated with Daptomycin (dosage: NA) starting Sep 19, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Liver Function Test Abnormal
This opens a possibility that Daptomycin could cause liver function test abnormal and that some male patients may be more susceptible.

Eosinophilic Pneumonia
A 55-year-old male patient (weight: NA) from US with the following symptoms: osteomyelitis started Daptomycin treatment (dosage: NA) on Apr 29, 2013. Soon after starting Daptomycin treatment, the consumer experienced several side effects, including:
  • Eosinophilic Pneumonia
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Daptomycin side effects, such as eosinophilic pneumonia.

Thrombocytopenia
This thrombocytopenia side effect was reported by a pharmacist from US. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumonia.The patient was prescribed Daptomycin (dosage: NA), which was started on Aug 19, 2013. Concurrently used drugs:
  • Allopurinol
  • Atenolol
  • Azithromycin
  • Chlorthalidone
  • Clonidine
  • Glipizide
  • Methylprednisone
  • Warfarin
.When starting to take Daptomycin the consumer reported symptoms, such as:
  • Thrombocytopenia
These side effects may potentially be related to Daptomycin.

Dyspnoea, Eosinophilic Pneumonia
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: abscess,spinal disorder,enterococcal infection, who was treated with Daptomycin (dosage: 750 Mg Qd Intravenous, start time: Jul 02, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Dyspnoea
  • Eosinophilic Pneumonia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Daptomycin treatment in male patients, resulting in dyspnoea side effect. The patient was hospitalized.

Alveolitis Allergic, Pyrexia, Respiratory Depression
This report suggests a potential Daptomycin Alveolitis Allergic, Pyrexia, Respiratory Depression side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pyrexia,arthritis bacterial and used Daptomycin (dosage: Daptomycin 450mg Iv Daily) starting Jul 20, 2013. Soon after starting Daptomycin the patient began experiencing various side effects, including:
  • Alveolitis Allergic
  • Pyrexia
  • Respiratory Depression
Drugs used concurrently: NA.The patient was hospitalized. Although Daptomycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as alveolitis allergic, may still occur.

Renal Failure Acute, Rhabdomyolysis
This Renal Failure Acute, Rhabdomyolysis problem was reported by a pharmacist from US. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal failure acute,rhabdomyolysis. On Apr 25, 2013 this consumer started treatment with Daptomycin (dosage: 390mg, Other, Iv). The following drugs were being taken at the same time: NA. When commencing Daptomycin, the patient experienced the following unwanted symptoms/side effects:
  • Renal Failure Acute
  • Rhabdomyolysis
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as renal failure acute, may become evident only after a product is in use by the general population.

Rash Erythematous, Urticaria
This is a report of a 61-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: infection and was treated with Daptomycin (dosage: NA) starting Oct 24, 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Rash Erythematous
  • Urticaria
The patient was hospitalized. This opens a possibility that Daptomycin treatment could cause the above reactions, including rash erythematous, and some male subjects may be more susceptible.

Rash
A 51-year-old female patient (weight: NA) from US with the following symptoms/conditions: febrile neutropenia started Daptomycin treatment (dosage: 2 G, Q8h) on Sep 26, 2011. Soon after starting Daptomycin treatment, the subject experienced various side effects, including:
  • Rash
Concurrently used drugs:
  • Vancomycin (1 Unk, Q12h)
  • Doryx /00055701/ (100 Mg, Q12h)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Daptomycin.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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    Daptomycin Safety Alerts, Active Ingredients, Usage Information

    NDC0409-0106
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDaptomycin
    NameDAPTOMYCIN
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteINTRAVENOUS
    On market since20140912
    LabelerHospira, Inc.
    Active Ingredient(s)DAPTOMYCIN
    Strength(s)50
    Unit(s)mg/mL
    Pharma ClassLipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient]

    More About Daptomycin

    Side Effects reported to FDA: 258

    Daptomycin safety alerts: 2013 2010 2008

    Reported deaths: 8

    Reported hospitalizations: 117

    Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

    [Posted 07/29/2010]

    AUDIENCE: Infectious Disease, Pulmonology

    ISSUE:  FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed. 

    BACKGROUND: FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System. FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

    RECOMMENDATION: Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.

    Additional information for Healthcare Professionals, Information for Patients, a Data Summary, and References are provided in the Drug Safety Communication at the link below.

    [07/29/2010 - Drug Safety Communication - FDA]
    [Jan 2010 - Cubicin (daptomycin) Prescribing Information - Cubist Pharmaceuticals]

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