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Flolan

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Flolan

Flolan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Flolan (epoprostenol sodium) is used to treat pulmonary hypertension. It is a prostaglandin (a hormone-like substance that occurs naturally in the body). This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, dizziness, headache, flushing, sweating, abdominal pain, jaw pain, muscle/joint pain, or pain/redness/swelling at the injection site.

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. Flolan may interact with diuretics (water pills), heart or blood pressure medications, heparin or warfarin, medication used to prevent blood clots, aspirin or NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications you use. During pregnancy, Flolan should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Flolan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • chest pain, trouble breathing;
  • fast, slow, or uneven heart rate;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine or stools;
  • coughing up blood;
  • feeling like you might pass out; or
  • numbness or increased sensitivity anywhere in your body.

Less serious side effects may include:

  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, diarrhea, stomach pain;
  • headache or jaw pain;
  • joint or muscle pain;
  • dizziness, sweating; or
  • feeling anxious, nervous, or agitated.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Flolan Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, dizziness, headache, flushing, sweating, abdominal pain, jaw pain, muscle/joint pain, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, nervousness, confusion, agitation), signs of infection (such as fever, chills), numb/tingling/pale skin, fast/slow/irregular heartbeat, vision changes, chest pain, unusual bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Flolan (Epoprostenol sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Flolan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

During clinical trials, adverse events were classified as follows: (1) adverse events during dose initiation and escalation, (2) adverse events during chronic dosing, and (3) adverse events associated with the drug delivery system.

Adverse Events During Dose Initiation and Escalation

During early clinical trials, FLOLAN (epoprostenol sodium) was increased in 2-ng/kg/min increments until the patients developed symptomatic intolerance. The most common adverse events and the adverse events that limited further increases in dose were generally related to vasodilation, the major pharmacologic effect of FLOLAN (epoprostenol sodium) . The most common dose-limiting adverse events (occurring in ≥ 1% of patients) were nausea, vomiting, headache, hypotension, and flushing, but also include chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia. Table 3 lists the adverse events reported during dose initiation and escalation in decreasing order of frequency.

Table 3: Adverse Events During Dose Initiation and Escalation

Adverse Events Occurring in ≥ 1% of Patients FLOLAN
(n = 391)
Flushing 58%
Headache 49%
Nausea/vomiting 32%
Hypotension 16%
Anxiety, nervousness, agitation 11%
Chest pain 11%
Dizziness 8%
Bradycardia 5%
Abdominal pain 5%
Musculoskeletal pain 3%
Dyspnea 2%
Back pain 2%
Sweating 1%
Dyspepsia 1%
Hypesthesia/paresthesia 1%
Tachycardia 1%

Adverse Events During Chronic Administration

Interpretation of adverse events is complicated by the clinical features of PAH, which are similar to some of the pharmacologic effects of FLOLAN (epoprostenol sodium) (e.g., dizziness, syncope). Adverse events which may be related to the underlying disease include dyspnea, fatigue, chest pain, edema, hypoxia, right ventricular failure, and pallor. Several adverse events, on the other hand, can clearly be attributed to FLOLAN (epoprostenol sodium) . These include hypotension, bradycardia, tachycardia, pulmonary edema, bleeding at various sites, thrombocytopenia, headache, abdominal pain, pain (unspecified), sweating, rash, arthralgia, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety/nervousness, and agitation. In addition, chest pain, fatigue, and pallor have been reported during FLOLAN (epoprostenol sodium) therapy, and a role for the drug in these events cannot be excluded.

Adverse Events During Chronic Administration for Idiopathic or Heritable PAH

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 4 lists adverse events that occurred at a rate at least 10% greater on FLOLAN (epoprostenol sodium) in controlled trials.

Table 4: Adverse Events Regardless of Attribution Occurring in Patients With Idiopathic or Heritable PAH With ≥ 10% Difference Between FLOLAN (epoprostenol sodium) and Conventional Therapy Alone

Adverse Event FLOLAN
(n = 52)
Conventional Therapy
(n = 54)
Occurrence More Common With FLOLAN
General
  Chills/fever/sepsis/flu-like symptoms 25% 11%
Cardiovascular
  Tachycardia 35% 24%
  Flushing 42% 2%
Gastrointestinal
  Diarrhea 37% 6%
  Nausea/vomiting 67% 48%
Musculoskeletal
  Jaw pain 54% 0%
  Myalgia 44% 31%
  Nonspecific musculoskeletal pain 35% 15%
Neurological
  Anxiety/nervousness/tremor 21% 9%
  Dizziness 83% 70%
  Headache 83% 33%
  Hypesthesia, hyperesthesia, paresthesia 12% 2%

Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving FLOLAN (epoprostenol sodium) .

Adverse Events During Chronic Administration for PAH/SSD

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 5 lists adverse events that occurred at a rate at least 10% greater on FLOLAN (epoprostenol sodium) in the controlled trial.

Table 5: Adverse Events Regardless of Attribution Occurring in Patients with PAH/SSD With ≥ 10% Difference Between FLOLAN (epoprostenol sodium) and Conventional Therapy Alone

Adverse Event FLOLAN
(n = 56)
Conventional Therapy
(n = 55)
Occurrence More Common With FLOLAN
Cardiovascular
  Flushing 23% 0%
  Hypotension 13% 0%
Gastrointestinal
  Anorexia 66% 47%
  Nausea/vomiting 41% 16%
  Diarrhea 50% 5%
Musculoskeletal
  Jaw pain 75% 0%
  Pain/neck pain/arthralgia 84% 65%
Neurological
  Headache 46% 5%
Skin and Appendages
  Skin ulcer 39% 24%
  Eczema/rash/urticaria 25% 4%

Although the relationship to FLOLAN (epoprostenol sodium) administration has not been established, pulmonary embolism has been reported in several patients taking FLOLAN (epoprostenol sodium) and there have been reports of hepatic failure.

Adverse Events Attributable to the Drug Delivery System

Chronic infusions of FLOLAN (epoprostenol sodium) 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 (epoprostenol sodium) . This rate was higher than reported in patients using chronic indwelling central venous catheters to administer parenteral nutrition, but lower than reported in oncology patients using these catheters. Malfunctions in the delivery system resulting in an inadvertent bolus of or a reduction in FLOLAN (epoprostenol sodium) were associated with symptoms related to excess or insufficient FLOLAN (epoprostenol sodium) , respectively (see ADVERSE REACTIONS: Adverse Events During Chronic Administration).

Observed During Clinical Practice

In addition to adverse reactions reported from clinical trials, the following events have been identified during post-approval use of FLOLAN (epoprostenol sodium) . Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to FLOLAN (epoprostenol sodium) .

Blood and Lymphatic: Anemia, hypersplenism, pancytopenia, splenomegaly.

Endocrine and Metabolic: Hyperthyroidism.

Read the entire FDA prescribing information for Flolan (Epoprostenol sodium) »

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Flolan - User Reviews

Flolan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Flolan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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