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Flolan

Last reviewed on RxList: 12/1/2016
Flolan Side Effects Center

Last reviewed on RxList 11/30/2016

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,
  • injection site reactions (pain, redness, swelling),
  • anxiety,
  • nervousness, or
  • agitation.

Contact your doctor if you have severe side effects of Flolan including:

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 (nonsteroidal 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 breastfeeding.

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.

Flolan Consumer Information

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)

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 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)

Related Resources for Flolan

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© 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.

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