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Flolan Side Effects

Generic Name: epoprostenol

Note: This document contains side effect information about epoprostenol. Some of the dosage forms listed on this page may not apply to the brand name Flolan.

For the Consumer

Applies to epoprostenol: intravenous powder for solution

Along with its needed effects, epoprostenol (the active ingredient contained in Flolan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epoprostenol:

More Common

  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • changes in skin color
  • chest congestion
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cold hands and feet
  • confusion
  • constipation
  • convulsions
  • cough or hoarseness
  • coughing up blood
  • decreased urine
  • depression
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • incoherent speech
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • increased urination
  • local infection at the catheter site
  • loss of appetite
  • metallic taste
  • muscle pain or cramps
  • muscle weakness
  • nausea or vomiting
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pain at the injection site
  • pain, redness, or swelling in the arm or leg
  • paleness of the skin
  • prolonged bleeding from cuts
  • rapid weight gain
  • red or black, tarry stools
  • redness of the face, neck, arms, and occasionally, upper chest
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • weight gain or loss

Less Common

  • Altered or abnormal touch sensation or sensitivity
  • blue lips and fingernails
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing that sometimes produces a pink frothy sputum
  • difficult, fast, or noisy breathing
  • inability to speak
  • increased sweating
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • seizures
  • severe or sudden headache
  • severe pain in the chest
  • slurred speech
  • sudden onset of severe breathing
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weakness or heaviness of the legs

Incidence Not Known

  • Feeling of fullness
  • high fever
  • pinpoint red spots on the skin
  • sensitivity to heat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trouble sleeping
  • troubled breathing with exertion

Some side effects of epoprostenol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Change in vision
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • heartburn
  • hives or welts
  • impaired vision
  • itching
  • joint pain
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • muscle pains or stiffness
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • skin rash, encrusted, scaly and oozing
  • sores on the skin
  • swollen joints
  • tiredness
  • trembling or shaking of the hands or feet
  • trouble concentrating

Less Common

  • Acid or sour stomach
  • belching
  • blurred vision or other changes in vision
  • excess air or gas in the stomach or intestines
  • indigestion
  • leg cramps
  • passing gas
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset

For Healthcare Professionals

Applies to epoprostenol: intravenous powder for injection

General

The most frequently reported side effects during initiation and dose escalation were nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia.

The most frequently reported side effects during chronic dosing were jaw pain, headache, flushing, diarrhea, nausea, vomiting, flu-like symptoms, and anxiety/nervousness.[Ref]

Cardiovascular

Very common (10% or more): Palpitation (63%), flushing (up to 58%), cyanosis (up to 54%), tachycardia (up to 35%), pallor (up to 32%), hypotension (up to 27%), right heart failure (up to 25%), heart failure (23%)

Common (1% to 10%): Bradycardia, myocardial infarction, shock, peripheral vascular disorder, vascular disorder[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 83%), headache (up to 83%), tremor (21%), hyperkinesia (up to 21%), syncope (up to 13%), hypesthesia (up to 12%), paresthesia (up to 12%), hyperesthesia (12%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 67%), esophageal reflux/gastritis (61%), diarrhea (up to 50%), ascites (up to 23%)

Common (1% to 10%): Abdominal pain, dyspepsia, abdominal colic

Uncommon (0.1% to 1%): Dry mouth[Ref]

Musculoskeletal

Very common (10% or more): Pain/neck pain/arthralgia (up to 84%), nonspecific musculoskeletal pain (up to 84%), jaw pain (up to 75%), myalgia (44%)

Common (1% to 10%): Back pain, leg cramp

Frequency not reported: Collagen disease[Ref]

Other

Very common (10% or more): Weight decreased (45%), pain (up to 29%), chills/fever/sepsis/flu-like symptoms (25%), fever (21%), hemorrhage/ hemorrhage injection

site/ hemorrhage rectal (11%), chest pain (11%)

Common (1% to 10%): Asthenia, sepsis, septicemia, procedural complication

Very rare (less than 0.01%): Lassitude

Frequency not reported: Fatigue, edema, catheter-related infection[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia, bleeding

Postmarketing reports: Anemia, hypersplenism, pancytopenia, splenomegaly[Ref]

Endocrine

Very rare (less than 0.01%): Hyperthyroidism[Ref]

Respiratory

Very common (10% or more): Hypoxia (up to 55%)

Common (1% to 10%): Dyspnea, pneumothorax, hemothorax, cough increased, epistaxis, pharyngitis, pleural effusion, sinusitis, pulmonary edema, respiratory disorder

Postmarketing reports: Pulmonary embolism[Ref]

Local

Very common (10% or more): Infection (18%), pain (up to 13%)

Very rare (less than 0.01%): Erythema[Ref]

Psychiatric

Very common (10% or more): Anxiety/nervousness (up to 21%), depression (up to 13%), agitation (11%)

Common (1% to 10%): Insomnia

Postmarketing reports: Acute confusional state[Ref]

Dermatologic

Very common (10% or more): Skin ulcer (39%), eczema/rash/urticaria (up to 25%)

Common (1% to 10%): Sweating, cellulitis[Ref]

Genitourinary

Common (1% to 10%): Hematuria, urinary tract infection[Ref]

Hepatic

Postmarketing reports: Hepatic failure[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 66%)

Common (1% to 10%): Hyperkalemia, hypercalcemia

Frequency not reported: Blood glucose increased[Ref]

References

1. "Product Information. Epoprostenol Sodium (epoprostenol)." Teva Pharmaceuticals USA, North Wales, PA.

2. "Product Information. Flolan (epoprostenol)." Glaxo Wellcome, Research Triangle Park, NC.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Veletri (epoprostenol)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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