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 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 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 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 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 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 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 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 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 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
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