FLOLAN: 156 Adverse Event Reports & Safety Profile
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156
Total FAERS Reports
42 (26.9%)
Deaths Reported
79
Hospitalizations
156
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities
First Report: 20050207 · Latest Report: 20140526
What Are the Most Common FLOLAN Side Effects?
#1 Most Reported
Dyspnoea
28 reports (17.9%)
#2 Most Reported
Investigation
27 reports (17.3%)
#3 Most Reported
Death
27 reports (17.3%)
All FLOLAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 28 | 18.0% | 8 | 25 |
| Death | 27 | 17.3% | 27 | 18 |
| Investigation | 27 | 17.3% | 13 | 27 |
| Diarrhoea | 23 | 14.7% | 6 | 13 |
| Nausea | 22 | 14.1% | 7 | 16 |
| Pain in jaw | 19 | 12.2% | 3 | 10 |
| Headache | 16 | 10.3% | 4 | 8 |
| Malaise | 16 | 10.3% | 7 | 14 |
| Pneumonia | 16 | 10.3% | 8 | 16 |
| Medical device complication | 15 | 9.6% | 3 | 9 |
| Device related infection | 14 | 9.0% | 0 | 11 |
| Cough | 13 | 8.3% | 1 | 11 |
| Nasopharyngitis | 13 | 8.3% | 2 | 8 |
| Central venous catheterisation | 12 | 7.7% | 2 | 10 |
| Dizziness | 12 | 7.7% | 3 | 9 |
| Flushing | 12 | 7.7% | 2 | 5 |
| Vomiting | 12 | 7.7% | 4 | 9 |
| Catheter site erythema | 11 | 7.1% | 1 | 6 |
| Rash | 11 | 7.1% | 0 | 3 |
| Chest pain | 10 | 6.4% | 4 | 9 |
Who Reports FLOLAN Side Effects? Age & Gender Data
Average age: 49.4 years. Most reports from: US. View detailed demographics →
Is FLOLAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2007 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2011 | 14 | 4 | 10 |
| 2012 | 26 | 14 | 24 |
| 2013 | 30 | 6 | 13 |
| 2014 | 15 | 5 | 7 |
What Is FLOLAN Used For?
| Indication | Reports |
|---|---|
| Pulmonary arterial hypertension | 89 |
| Cor pulmonale chronic | 32 |
| Product used for unknown indication | 18 |
| Pulmonary hypertension | 8 |
FLOLAN vs Alternatives: Which Is Safer?
FLOLAN vs FLUCICLOVINE F-18
FLOLAN vs FLUCLOXACILLIN
FLOLAN vs FLUCONAZOLE
FLOLAN vs FLUCYTOSINE
FLOLAN vs FLUDARABINE
FLOLAN vs FLUDEOXYGLUCOSE F-18
FLOLAN vs FLUDROCORTISONE
FLOLAN vs FLUINDIONE
FLOLAN vs FLUMAZENIL
FLOLAN vs FLUMETHASONE
Official FDA Label for FLOLAN
Official prescribing information from the FDA-approved drug label.