Flolan
- Generic Name: epoprostenol sodium
- Brand Name: Flolan
- Drug Class: PAH, Prostacyclin Analogs
Flolan (Epoprostenol sodium) side effects drug center
Flolan Side Effects Center
What Is Flolan?
Flolan (epoprostenol sodium) is a prostaglandin (a hormone-like substance that occurs naturally in the body) used to treat pulmonary hypertension. Flolan is available in generic form.
What Are Side Effects of Flolan?
Common side effects of Flolan include:
- nausea,
- vomiting,
- diarrhea,
- dizziness,
- headache,
- flushing (redness, warmth, or tingly feeling),
- sweating,
- stomach pain,
- jaw pain,
- muscle or joint pain,
- injection site reactions (pain, redness, swelling),
- anxiety,
- nervousness, or
- agitation.
Contact your doctor if you have severe side effects of Flolan including:
- fever,
- trouble breathing,
- fainting,
- chest pain,
- irregular heart rate, or
- coughing up blood.
Dosage for Flolan
Because Flolan is used long-term, it is usually given through a permanent central intravenous (IV) catheter placed into a large vein. The first dose is given in a hospital or clinic setting to monitor the patient for side effects.
What Drugs, Substances, or Supplements Interact with Flolan?
Flolan may interact with diuretics (water pills), heart or blood pressure medications, heparin or warfarin, medication used to prevent blood clots, aspirin or NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications you use.
Flolan During Pregnancy and Breastfeeding
During pregnancy, Flolan should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Flolan (epoprostenol sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Flolan Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- shortness of breath with dizziness or weakness;
- a light-headed feeling, like you might pass out;
- easy bruising, unusual bleeding; or
- symptoms of pulmonary edema--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.
Common side effects may include:
- flushing (warmth, redness, or tingly feeling);
- dizziness;
- nausea, vomiting, diarrhea, stomach pain;
- trouble breathing;
- headache, jaw pain;
- fast or slow heartbeats;
- joint or muscle pain;
- flu-like symptoms; or
- feeling anxious or nervous.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Flolan (Epoprostenol sodium)
Flolan Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions are shown in Table 2 and are generally related to vasodilatory effects.
Table 2. Adverse Reactions Occurring in Patients with Idiopathic or Heritable PAH and with PAH Associated with Scleroderma Spectrum of Diseases (PAH/SSD) Occurring ≥10% More Frequently on FLOLAN than Conventional Therapy
| Adverse Reaction | Idiopathic or Heritable PAH | PAH/SSD | ||
| FLOLAN | Conventional Therapy | FLOLAN | Conventional Therapy | |
| (n = 52) | (n = 54) | (n = 56) | (n = 55) | |
| Body as a whole | ||||
| Jaw pain | 54% | 0% | 75% | 0% |
| Nonspecific musculoskeletal pain | 35% | 15% | 84% | 65% |
| Headache | 83% | 33% | 46% | 5% |
| Chills/fever/sepsis/flu-like symptoms | 25% | 11% | 13% | 11% |
| Cardiovascular system | ||||
| Flushing | 42% | 2% | 23% | 0% |
| Hypotension | 27% | 31% | 13% | 0% |
| Tachycardia | 35% | 24% | 43% | 42% |
| Digestive system | ||||
| Anorexia | 25% | 30% | 66% | 47% |
| Nausea/Vomiting | 67% | 48% | 41% | 16% |
| Diarrhea | 37% | 6% | 50% | 5% |
| Skin and Appendages | ||||
| Skin ulcer | - | - | 39% | 24% |
| Eczema/rash/urticaria | `10% | 13% | 25% | 4% |
| Musculoskeletal System | ||||
| Myalgia | 44% | 31% | - | - |
| Nervous system | ||||
| Anxiety/hyperkinesias/nervousness/tremor | 21% | 9% | 7% | 5% |
| Hyperesthesia/hypesthesia/paresthesia | 12% | 2% | 5% | 0% |
| Dizziness | 83% | 70% | 59% | 76% |
Adverse Events Attributable To The Drug Delivery System
Chronic infusions of FLOLAN are delivered using a small, portable infusion pump through an indwelling central venous catheter. During controlled PAH trials of up to 12 weeks’ duration, the local infection rate was about 18% and the rate for pain was about 11%. During long-term follow-up, sepsis was reported at a rate of 0.3 infections/patient per year in patients treated with FLOLAN.
Postmarketing Experience
The following events have been identified during postapproval use of FLOLAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Blood And Lymphatic
Anemia, hypersplenism, pancytopenia, splenomegaly, thrombocytopenia.
Cardiac
High output cardiac failure.
Endocrine And Metabolic
Hyperthyroidism.
Gastrointestinal
Hepatic failure.
Respiratory, Thoracic, And Mediastinal
Pulmonary embolism.
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Flolan (Epoprostenol sodium)
&Copy; Flolan Patient Information is supplied by Cerner Multum, Inc. and Flolan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.