September 3, 2015
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Flolan

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Flolan




Flolan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/28/2015

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. 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, pain/redness/swelling at the injection site, 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.

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

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 3 and are generally related to vasodilatory effects.

Table 3: 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
(n = 52)
Conventional Therapy
(n = 54)
FLOLAN
(n = 56)
Conventional Therapy
(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.

Endocrine and Metabolic

Hyperthyroidism.

Gastrointestinal

Hepatic failure.

Respiratory, Thoracic, and Mediastinal

Pulmonary embolism.

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

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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