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Daptomycin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 197 

Dyspnoea, Pyrexia, Alveolitis Allergic, Cough (8024381-5)
on Jan 05, 2012 Male from UNITED STATES , 56 years of age, weighting 292.6 lb, was diagnosed with
  • localised infection
and was treated with Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: dyspnoea, pyrexia, alveolitis allergic, cough. Daptomycin dosage: N/A.

Blood Creatine Phosphokinase Increased (7990746-0)
Patient was taking Daptomycin. Patient felt the following Daptomycin side effects: blood creatine phosphokinase increased on Dec 19, 2011 from UNITED STATES Additional patient health information: Male , weighting 289.9 lb, . Daptomycin dosage: 1000mg.

Eosinophilic Pneumonia (7967685-4)
Adverse event was reported on Dec 08, 2011 by a Male taking Daptomycin (Dosage: Daptomycin Dose Iv) was diagnosed with
  • device related infection
and. Location: UNITED STATES , 52 years of age, weighting 121.0 lb, After Daptomycin was administered, patient encountered several Daptomycin side effects: eosinophilic pneumonia. Patient was hospitalized.

Blood Potassium Increased, Rhabdomyolysis, Myopathy Toxic, Blood Creatinine Increased (7967269-8)
on Nov 28, 2011 Male from UNITED STATES , 69 years of age, weighting 293.2 lb, was treated with Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: blood potassium increased, rhabdomyolysis, myopathy toxic, blood creatinine increased. Daptomycin dosage: (900 Mg,1 D),intravenous.
Associated medications used:
  • Levofloxacin (750 Mg (750 Mg,1 In 1 D),oral)
  • Simvastatin (40 Mg (40 Mg,1 In 1 D))
Patient was hospitalized.


Rash Pruritic (7956977-0)
on Dec 05, 2011 Female from UNITED STATES , 81 years of age, weighting 139.8 lb, was diagnosed with
  • implant site infection
and was treated with Daptomycin. Patient felt the following Daptomycin side effects: rash pruritic. Daptomycin dosage: 372 Mg. Patient was hospitalized.

Lung Infiltration (7859265-6)
Patient was taking Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: lung infiltration on Oct 27, 2011 from UNITED STATES Additional patient health information: Male , 57 years of age, weighting 179.0 lb, was diagnosed with
  • bursitis infective staphylococcal
  • staphylococcal osteomyelitis
and. Daptomycin dosage: 480 Mg. Patient was hospitalized.

Blood Creatine Phosphokinase Increased (7792172-6)
Adverse event was reported on Oct 03, 2011 by a Female taking Daptomycin (Dosage: 475mg) was diagnosed with
  • cellulitis
and. Location: UNITED STATES , 29 years of age, weighting 175.9 lb, Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: blood creatine phosphokinase increased.

Eosinophilic Pneumonia, Pulmonary Oedema, Pleural Effusion (7788155-2)
on Sep 29, 2011 Male from UNITED STATES , weighting 317.5 lb, was diagnosed with
  • osteomyelitis
and was treated with Daptomycin 720mg Cubist Pharmaceuticals. Patient felt the following Daptomycin side effects: eosinophilic pneumonia, pulmonary oedema, pleural effusion. Daptomycin 720mg Cubist Pharmaceuticals dosage: 720mg Every 24 Hours Iv.

Urticaria, Rash Morbilliform, Eosinophilia, Pruritus (7776615-X)
on Sep 22, 2011 Male from UNITED STATES , 32 years of age, weighting 188.5 lb, was diagnosed with
  • bacteraemia
and was treated with Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: urticaria, rash morbilliform, eosinophilia, pruritus. Daptomycin dosage: 500 Mg Every Day Iv.

Rhabdomyolysis (7773062-1)
Patient was taking Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: rhabdomyolysis on Sep 21, 2011 from UNITED STATES Additional patient health information: Male , 82 years of age, weighting 198.2 lb, was diagnosed with
  • infection
  • hyperlipidaemia
and. Daptomycin dosage: 750 Mg Every Day Iv.
Associated medications used:
  • Simvastatin (20 Mg Every Day Po)


Abdominal Abscess (7759529-0)
Adverse event was reported on Sep 19, 2011 by a Male taking Daptomycin (Dosage: 500mg) was diagnosed with
  • abdominal infection
and. Location: UNITED STATES , weighting 174.2 lb, Patient felt the following Daptomycin side effects: abdominal abscess.

Liver Function Test Abnormal (7753700-X)
on Sep 15, 2011 Male from UNITED STATES , weighting 180.3 lb, was diagnosed with
  • extradural abscess
  • hyperlipidaemia
and was treated with Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: liver function test abnormal. Daptomycin dosage: 575 Mg.
Multiple concurrent drugs taken:
  • Lipitor (20 Mg)


Rhabdomyolysis (7742456-2)
on Sep 07, 2011 Male from UNITED STATES , 57 years of age, weighting 194.7 lb, was treated with Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: rhabdomyolysis. Daptomycin dosage: 750 Mg Every Day Iv. Patient was hospitalized.

Oedema Peripheral, Rhabdomyolysis (7740206-7)
Patient was taking Daptomycin. Patient felt the following Daptomycin side effects: oedema peripheral, rhabdomyolysis on Sep 09, 2011 from UNITED STATES Additional patient health information: Female , weighting 280.0 lb, . Daptomycin dosage: N/A. Patient was hospitalized.

Faeces Discoloured, Sleep Disorder, Haematocrit Decreased, Weight Increased, Eosinophilic Pneumonia, Decreased Appetite (7729647-1)
Adverse event was reported on Sep 01, 2011 by a Male taking Daptomycin (Dosage: 600 Mg Other Iv) was diagnosed with
  • osteomyelitis
and. Location: UNITED STATES , 68 years of age, weighting 219.4 lb, After Daptomycin was administered, patient encountered several Daptomycin side effects: faeces discoloured, sleep disorder, haematocrit decreased, weight increased, eosinophilic pneumonia, decreased appetite. Patient was hospitalized.

Blood Creatine Phosphokinase Increased (7675223-9)
on Aug 10, 2011 Male from UNITED STATES , weighting 160.7 lb, was treated with Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: blood creatine phosphokinase increased. Daptomycin dosage: N/A. Patient was hospitalized and became disabled.

Eosinophilic Pneumonia (7647724-0)
on Aug 01, 2011 Male from UNITED STATES , weighting 149.9 lb, was treated with Daptomycin. Patient felt the following Daptomycin side effects: eosinophilic pneumonia. Daptomycin dosage: N/A.

Aspartate Aminotransferase Increased, Pain In Extremity, Alanine Aminotransferase Increased, Myopathy (7629104-7)
Patient was taking Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: aspartate aminotransferase increased, pain in extremity, alanine aminotransferase increased, myopathy on Jul 22, 2011 from UNITED STATES Additional patient health information: Female , 70 years of age, was diagnosed with
  • infection
and. Daptomycin dosage: 468mg.
Multiple concurrent drugs taken:
  • Meropenem (1gm)
Patient was hospitalized.

Interstitial Lung Disease, Disease Complication, Pyrexia, Pulmonary Fibrosis, Fatigue, Dyspnoea (7629083-2)
Adverse event was reported on Jul 22, 2011 by a Male taking Daptomycin (Dosage: 550mg) was diagnosed with
  • arthritis infective
  • staphylococcal infection
and. Location: UNITED STATES , weighting 170.4 lb, Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: interstitial lung disease, disease complication, pyrexia, pulmonary fibrosis, fatigue, dyspnoea. Patient was hospitalized and became disabled.

Sinus Bradycardia, Cardio-respiratory Arrest, White Blood Cell Count Increased, Infusion Related Reaction, Pyrexia (7624202-6)
on Jul 20, 2011 Female from UNITED STATES , weighting 158.7 lb, was diagnosed with
  • arthritis infective
  • cellulitis
and was treated with Daptomycin. Patient felt the following Daptomycin side effects: sinus bradycardia, cardio-respiratory arrest, white blood cell count increased, infusion related reaction, pyrexia. Daptomycin dosage: 550 Mg.

Pyrexia, Leukocytosis, Lung Infiltration, Dyspnoea (7624197-5)
on Jul 20, 2011 Female from UNITED STATES , 59 years of age, weighting 235.9 lb, was diagnosed with
  • mediastinitis
and was treated with Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: pyrexia, leukocytosis, lung infiltration, dyspnoea. Daptomycin dosage: 1000mg. Patient was hospitalized.

Cardiovascular Insufficiency, Acute Hepatic Failure, Diarrhoea, Infection (7608305-8)
Patient was taking Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: cardiovascular insufficiency, acute hepatic failure, diarrhoea, infection on Jul 06, 2011 from SWITZERLAND Additional patient health information: Male , 63 years of age, weighting 187.4 lb, . Daptomycin dosage: N/A.

Eosinophilic Pneumonia (7602731-9)
Adverse event was reported on Jul 11, 2011 by a Male taking Daptomycin (Dosage: 420mg Daily Iv) was diagnosed with
  • endocarditis enterococcal
  • endocarditis staphylococcal
and. Location: UNITED STATES , 80 years of age, weighting 150.0 lb, Patient felt the following Daptomycin side effects: eosinophilic pneumonia. Patient was hospitalized.

Arrhythmia, Bradycardia, Myocarditis, Pulseless Electrical Activity, Pericardial Effusion, Cardiac Disorder, Lung Disorder, Pleural Effusion, Staphylococcal Infection (7586895-1)
on May 25, 2011 Female from UNITED STATES , 27 years of age, weighting 154.3 lb, was treated with Daptomycin. After Daptomycin was administered, patient encountered several Daptomycin side effects: arrhythmia, bradycardia, myocarditis, pulseless electrical activity, pericardial effusion, cardiac disorder, lung disorder, pleural effusion, staphylococcal infection. Daptomycin dosage: N/A.
Multiple concurrent drugs taken:
  • Atenolol
  • Promethazine
  • Atenolol
  • Primaxin
  • Ciprofloxacin
  • Acetaminophen
  • Atropine
  • Levaquin


Pneumonitis (7583049-X)
on Jun 27, 2011 Male from UNITED STATES , weighting 179.0 lb, was diagnosed with
  • osteomyelitis
and was treated with Daptomycin. Directly after, patient experienced the unwanted or unexpected Daptomycin side effects: pneumonitis. Daptomycin dosage: 500mg Q24h Iv. Patient was hospitalized.

Showing 1-25 of 197 

Daptomycin Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Daptomycin Information

More About Daptomycin

Side Effects reported to FDA: 197. View Daptomycin Adverse Reports

Daptomycin safety alerts: 2010 2008

Reported deaths: 7

Reported hospitalizations: 83

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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