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Flolan (Epoprostenol) - Device Related Infection - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Device Related Infection (32)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Flolan (Epoprostenol) where reactions include device related infection. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 32   Next >>

Possible Flolan side effects in 6 year old female

Reported by a pharmacist from United States on 2012-08-16

Patient: 6 year old female

Reactions: Viral Infection, Device Related Infection, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 6 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 6 year old female

Reactions: Device Related Infection, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 2 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 2 year old female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 39 year old female

Reactions: Catheter Site Discharge, Catheter Site Erythema, Pain, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 37 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Flushing, Diarrhoea, Pyrexia, Device Related Infection, Catheter Site Pain, Pain in JAW

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Adcirca



Possible Flolan side effects in 6 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 6 year old female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09

Patient: 34 year old female, weighing 145.1 kg (319.2 pounds)

Reactions: Catheter Site Swelling, Restless Legs Syndrome, Device Related Infection, Catheter Site Discharge, Catheter Site Erythema, Oxygen Saturation Decreased, Medical Device Complication, Chest Discomfort, Pain in Extremity, Nausea, Catheter Site Inflammation, Catheter Site Rash, Catheter Site Pain, Purulent Discharge, Infusion Site Extravasation, Infusion Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegaderm

Chloraprep

Flolan
    Dosage: 9.25ngkm continuous
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-10

Other drugs received by patient: Bismuth Subsalicylate; Fish OIL; Protonix; Neurontin; Cymbalta; Lexapro; Zofran; Aspirin; Imodium; Reglan; Multi-Vitamin; Coumadin; Acetaminophen; Humalog; Lasix; Synthroid; Lantus; Symbicort



Possible Flolan side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 43 year old female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 13 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 13 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: 34 year old female, weighing 145.1 kg (319.2 pounds)

Reactions: Catheter Site Swelling, Medical Device Complication, Chest Discomfort, Nausea, Pain in Extremity, Restless Legs Syndrome, Catheter Site Inflammation, Catheter Site Rash, Device Related Infection, Purulent Discharge, Oxygen Saturation Decreased, Infusion Site Extravasation, Infusion Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan
    Dosage: 9.25ngkm unknown
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-10

Chloraprep

Tegaderm

Other drugs received by patient: Zofran; Protonix; Multi-Vitamin; Humalog; Lantus; Acetaminophen; Coumadin; Aspirin; Imodium; Cymbalta; Synthroid; Bismuth Subsalicylate; Fish OIL; Neurontin; Reglan; Lasix; Symbicort; Lexapro



Possible Flolan side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 47 year old female, weighing 87.0 kg (191.4 pounds)

Reactions: Dyspnoea, Device Related Infection

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Lortab; Potassium Chloride; Ferrous Sulfate TAB; Aspirin; Synthroid; Lasix; Tracleer; Albuterol; Lorazepam; Spironolactone; Oxygen; Zithromax



Possible Flolan side effects in 37 year old male

Reported by a pharmacist from United States on 2012-05-30

Patient: 37 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Flushing, Diarrhoea, Pyrexia, Device Related Infection, Catheter Site Pain, Pain in JAW

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Adcirca



Possible Flolan side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: 34 year old female, weighing 145.1 kg (319.2 pounds)

Reactions: Medical Device Complication, Catheter Site Swelling, Catheter Site Inflammation, Catheter Site Rash, Device Related Infection, Purulent Discharge, Infusion Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegaderm

Chloraprep

Flolan
    Dosage: 9.25ngkm unknown
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-10

Other drugs received by patient: Neurontin; Coumadin; Lasix; Bismuth Subsalicylate; Humalog; Synthroid; Reglan; Fish OIL; Protonix; Acetaminophen; Zofran; Imodium; Cymbalta; Lantus; Lexapro; Aspirin; Symbicort; Multi-Vitamin



Possible Flolan side effects in 40 year old male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 40 year old male

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 57 year old female

Reported by a pharmacist from United States on 2012-05-23

Patient: 57 year old female, weighing 88.0 kg (193.6 pounds)

Reactions: Catheter Site Discharge, Catheter Site Swelling, Diarrhoea, Device Related Infection

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Albuterol; Furosemide; Revatio; Potassium Chloride; Spironolactone; Warfarin Sodium



Possible Flolan side effects in 13 year old female

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: 13 year old female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 52 year old female

Reported by a pharmacist from United States on 2012-05-09

Patient: 52 year old female, weighing 58.5 kg (128.7 pounds)

Reactions: Diarrhoea, Device Related Infection, Facial Pain, Pain in JAW, Infusion Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Novolog; Furosemide; Adcirca; Spironolactone; Claritin; Unknown



Possible Flolan side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-04-24

Patient: 34 year old female, weighing 145.1 kg (319.2 pounds)

Reactions: Catheter Site Swelling, Catheter Site Inflammation, Catheter Site Rash, Device Related Infection, Purulent Discharge, Infusion Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegaderm

Chloraprep

Flolan
    Dosage: 9.25ngkm unknown
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-04-10

Other drugs received by patient: Protonix; Humalog; Synthroid; Cymbalta; Lantus; Lasix; Zofran; Reglan; Coumadin; Aspirin; Imodium; Bismuth Subsalicylate; Multi-Vitamin; Lexapro; Fish OIL; Acetaminophen; Neurontin; Symbicort



Possible Flolan side effects in

Reported by a physician from United States on 2012-04-17

Patient:

Reactions: Death, Fluid Overload, Right Ventricular Failure, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Paracentesis, Ascites

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flolan

Epoprostenol Sodium
    Dosage: 51 ng/kg, per min

Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-04

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Potassium Chloride; Aldactone; Sildenafil; Ferrous Sulfate TAB; Lasix; Viagra



Possible Flolan side effects in 52 year old female

Reported by a pharmacist from United States on 2012-04-09

Patient: 52 year old female

Reactions: Diarrhoea, Device Related Infection, Facial Pain, Pain in JAW, Infusion Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Novolog; Unknown; Adcirca; Furosemide; Spironolactone; Claritin



Possible Flolan side effects in

Reported by a pharmacist from United States on 2012-03-28

Patient:

Reactions: Right Ventricular Failure, Fluid Overload, Death, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Paracentesis, Ascites

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 51 ng/kg, per min
    Start date: 2011-07-05

Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-02

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Flolan

Other drugs received by patient: Ferrous Sulfate TAB; Aldactone; Potassium Chloride; Sildenafil; Lasix; Viagra



Possible Flolan side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-28

Patient:

Reactions: Fluid Overload, Right Ventricular Failure, Death, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Paracentesis, Ascites

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 51 ng/kg, per min
    Start date: 2011-07-05

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Flolan

Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-02

Other drugs received by patient: Sildenafil; Ferrous Sulfate TAB; Potassium Chloride; Lasix; Viagra; Aldactone



Possible Flolan side effects in female

Reported by a consumer/non-health professional from Canada on 2012-03-22

Patient: female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan
    Indication: Pulmonary Hypertension
    Start date: 2009-11-02

Flolan
    Indication: Pulmonary Hypertension
    Start date: 2009-11-02



Possible Flolan side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: 65 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Back Pain, Dyspnoea, Device Related Infection, Staphylococcal Sepsis, Death, Intervertebral Disc Disorder, Sepsis, Hypoxia, Abscess, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Tylenol; Multi-Vitamin; Furosemide; Triamcinolone; Tracleer; Potassium; Claritin



Possible Flolan side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-02-09

Patient: 52 year old female

Reactions: Device Related Infection, Infusion Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Spironolactone; Furosemide



Possible Flolan side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-01-26

Patient: 42 year old female

Reactions: Medical Device Complication, Lung Disorder, Dyspnoea, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Letairis; Revatio



Possible Flolan side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24

Patient:

Reactions: Fluid Overload, Right Ventricular Failure, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Paracentesis, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-04

Flolan

Other drugs received by patient: Viagra; Potassium Chloride; Aldactone; Coumadin; Lasix; Sildenafil; Ferrous Sulfate TAB



Possible Flolan side effects in

Reported by a pharmacist from United States on 2012-01-19

Patient:

Reactions: Right Ventricular Failure, Fluid Overload, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-04

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Flolan

Other drugs received by patient: Sildenafil; Lasix; Potassium Chloride; Aldactone; Coumadin; Ferrous Sulfate TAB; Viagra



Possible Flolan side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19

Patient:

Reactions: Fluid Overload, Right Ventricular Failure, Dyspnoea, Cardiac Failure, Oedema Peripheral, Abdominal Distension, Device Related Infection, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2004-05-25

Epoprostenol Sodium
    Dosage: 32 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-04

Flolan

Other drugs received by patient: Ferrous Sulfate TAB; Aldactone; Viagra; Potassium Chloride; Coumadin; Lasix; Sildenafil



Possible Flolan side effects in

Reported by a physician from United States on 2011-12-19

Patient:

Reactions: Catheter Site Swelling, Catheter Site Erythema, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2003-09-05

Flolan
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin



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