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Flolan (Epoprostenol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Flolan (Epoprostenol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (574)
Death (101)
Life Threatening Events (36)
Disability (11)

Reports by Reaction Type

Dyspnoea (74)Death (68)Diarrhoea (48)Pneumonia (40)Nausea (39)Vomiting (35)Device Related Infection (32)Pain in JAW (31)Ascites (30)Oedema Peripheral (29)Headache (28)Cardiac Failure (28)

Below are a few examples of reports where side effects / adverse reactions may be related to Flolan (Epoprostenol). For a complete list or a specific selection of reports, please use the links above.

Possible Flolan side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 59 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Off Label Use, Procedural Complication, Pulmonary Artery Thrombosis, Treatment Noncompliance

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Product Used FOR Unknown Indication

Flolan
    Dosage: 32ngkm unknown
    Indication: Heart Disease Congenital
    Start date: 2011-05-10
    End date: 2012-08-07

Other drugs received by patient: Dobutamine



Possible Flolan side effects in 48 year old female

Reported by a physician from United States on 2012-08-27

Patient: 48 year old female

Reactions: Medical Device Complication, Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 48 year old female

Reported by a pharmacist from United States on 2012-08-27

Patient: 48 year old female

Reactions: Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 81 year old female, weighing 52.2 kg (114.7 pounds)

Reactions: HIP Fracture, Joint Swelling, Drug Ineffective, Diarrhoea, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan
    Dosage: 5 mg, unk
    Indication: Pulmonary Arterial Hypertension

Revatio
    Dosage: 80 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Viagra
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Ambrisentan; Cubicin



Possible Flolan side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 53 year old female

Reactions: Vomiting, Nausea, Tachycardia, Hypotension, Multi-Organ Failure, Death, Endotracheal Intubation, Myocardial Infarction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 38 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 38 year old female

Reactions: Gastrointestinal Haemorrhage, Abdominal Symptom, Failure To Thrive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Coumadin



Possible Flolan side effects in 13 year old female

Reported by a physician from United States on 2012-08-22

Patient: 13 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Medical Device Complication, Dyspnoea, Presyncope, Dizziness, Treatment Noncompliance

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Sildenafil; Bosentan



Possible Flolan side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 71 year old female

Reactions: Therapy Regimen Changed

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Indication: Product Used FOR Unknown Indication

Flolan
    Indication: Product Used FOR Unknown Indication

Letairis
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-14



Possible Flolan side effects in 29 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 29 year old female

Reactions: Rash, Catheter Site Haemorrhage

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 60 year old female

Reported by a pharmacist from United States on 2012-08-20

Patient: 60 year old female

Reactions: Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 36 year old female, weighing 89.5 kg (196.9 pounds)

Reactions: Pain in Extremity, Diarrhoea, Oedema Peripheral, Tendonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Fluticasone Propionate; Isentress; Singulair; Tylenol W / Codeine; Valtrex; Combivent; Depo-Provera; Spironolactone; Ferrous Gluconate; Loperamide; Gabapentin; Sodium Chloride; Truvada; Letairis; Oxygen



Possible Flolan side effects in 38 year old female

Reported by a pharmacist from United States on 2012-08-20

Patient: 38 year old female

Reactions: Flushing, Chest Pain, Intestinal Obstruction, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Metoprolol Tartrate; Reglan; Morphine; Tracleer; Digoxin; Colace



Possible Flolan side effects in 42 year old female

Reported by a pharmacist from United States on 2012-08-17

Patient: 42 year old female

Reactions: Pancreatic Disorder, Syncope, Vomiting, Nausea, Weight Fluctuation, Nocturnal Dyspnoea, Loss of Consciousness

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 71 year old female

Reactions: Therapy Regimen Changed

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Indication: Product Used FOR Unknown Indication

Flolan
    Indication: Product Used FOR Unknown Indication

Letairis
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-14



Possible Flolan side effects in 51 year old female

Reported by a physician from United States on 2012-08-17

Patient: 51 year old female

Reactions: Diabetes Mellitus, Haemoptysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Therapy Regimen Changed

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Indication: Product Used FOR Unknown Indication

Flolan
    Indication: Product Used FOR Unknown Indication

Letairis
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-14



Possible Flolan side effects in 61 year old female

Reported by a pharmacist from United States on 2012-08-17

Patient: 61 year old female

Reactions: Death, Fatigue, Dyspnoea, Abdominal Distension, Disease Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 16 year old male

Reported by a pharmacist from United States on 2012-08-17

Patient: 16 year old male

Reactions: Pseudomonal Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 57 year old male

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

Patient: 57 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Death, Dyspnoea, Chest Pain

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Coumadin



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 50 year old male

Reported by a pharmacist from United States on 2012-08-15

Patient: 50 year old male

Reactions: Vomiting, Nausea, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 56 year old male

Reactions: Right Ventricular Failure, Fluid Overload, Dyspnoea, Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 41 year old female

Reactions: Abdominal Pain, Vomiting, Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 53 year old

Reported by a pharmacist from United States on 2012-08-15

Patient: 53 year old

Reactions: Vomiting, Nausea, Tachycardia, Hypotension, Endotracheal Intubation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female

Reactions: Therapy Regimen Changed

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium

Flolan

Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-14



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 71 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 71 year old female

Reactions: Death, Diarrhoea

Adverse event resulted in: death

Drug(s) suspected as cause:
Flolan



Possible Flolan side effects in 38 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 38 year old female

Reactions: Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Tracleer; Beraprost Sodium; Adcirca



Possible Flolan side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 38 year old female

Reactions: Chest Pain, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Tracleer; Colace; Reglan; Digoxin; Morphine; Metoprolol



Possible Flolan side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 44 year old female, weighing 70.5 kg (155.1 pounds)

Reactions: Pneumonia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Flolan

Other drugs received by patient: Revatio

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