Flolan Side Effects

Generic Name: epoprostenol

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

Not all side effects for Flolan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to epoprostenol: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by epoprostenol (the active ingredient contained in Flolan). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with epoprostenol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Adverse effects due to epoprostenol (the active ingredient contained in Flolan) are often difficult to distinguish from the symptoms of primary pulmonary hypertension. Adverse effects due to the disease state have included dyspnea, fatigue, chest pain, right ventricular failure and pallor. Side effects more common due to the drug have included headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms and anxiety.

Cardiovascular

Bugiardini and colleagues reported that epoprostenol (the active ingredient contained in Flolan) at therapeutic doses has been shown to induced myocardial ischemia (angina, ST segment depression, reduced lactate consumption) in patients with advanced coronary artery disease. The mechanism may be due to a maldistribution of blood flow. Counteraction of ischemia was achieved with aminophylline.

Proarrhythmic and antiarrhythmic effects have been rarely reported. In one study, epoprostenol infusion increased the induction of atrial and ventricular arrhythmias and decreased atrial and AV nodal conduction times possibly related to an increase in adrenergic tone.

Davenport and colleagues reported on 8 patients receiving direct femoral infusions of epoprostenol (5 ng/kg/min) for 30 minutes prior to hemodialysis to prevent extracorporeal clotting. All patients had fulminant hepatic failure and acute renal failure due to acetaminophen self-poisoning. Mean arterial pressure, cerebral perfusion pressure and arterial oxygen pressure all decreased. Intracranial pressure increased while cardiac output did not change. Four of these patients subsequently died due to cerebral edema. The authors suggest to administer epoprostenol only via the infusion port on the extracorporeal circuit, and not directly, in patients with hepatic and renal failure requiring hemodialysis to help prevent changes in cerebral perfusion pressure and oxygen delivery.

Zusman and colleagues reported that epoprostenol at 8 ng/kg/min, compared to 2 ng/kg/min or 4 ng/kg/min lead to increased adverse effects in patients with chronic renal failure undergoing hemodialysis anticoagulation. Hypotension was the primary adverse cardiovascular event requiring discontinuation of the higher dosage. Hemodynamic changes included a decreased blood pressure and increased heart rate. Patients with chronic renal failure may exhibit increased hemodynamic sensitivity, possibly due to higher basal plasma prostaglandin levels.

Cardiovascular side effects have included flushing (58% of patients) and hypotension (16%). These two side effects are commonly dose-limiting in the acute dose-ranging phase of epoprostenol administration. These effects have usually occurred due to potent vasodilation. Chest pain (11%), bradycardia (5%) and tachycardia (1%) have also been reported during acute dosing. Adverse cardiovascular events occurring during chronic infusions include tachycardia (35%) and flushing (42%). Fatal cerebral edema has been reported.

Nervous system

In dose-ranging studies headache was the dose-limiting side effect most frequently reported.

Nervous system side effects have included reports of headache (due to vasodilation) in approximately 50% of patients during acute dose ranging and in 83% of patients during chronic dosing. Anxiety, nervousness, and agitation have been reported in 11% of patients and dizziness in 8% of patients during acute phase dose ranging. Anxiety, nervousness and tremor have been reported in 21% of patients during the chronic phase.

Gastrointestinal

Gastrointestinal side effects have included reports of nausea and vomiting in 32% of patients during the acute dose ranging phase and in 67% of patients during chronic dosing. Dyspepsia and abdominal pain have occurred in less than 5% of patients during acute dosing. Diarrhea has been reported in 67% of patients during the chronic phase.

Zusman and colleagues reported that epoprostenol at 8 ng/kg/min, compared to 2 ng/kg/min or 4 ng/kg/min lead to increased adverse effects in patients with chronic renal failure undergoing hemodialysis anticoagulation. Nausea and vomiting were the 2 primary adverse gastrointestinal events requiring discontinuation of the higher dosage.

Musculoskeletal

Musculoskeletal side effects have included rare reports of back pain and musculoskeletal pain during acute dosing. In the chronic phase, jaw pain (54%), myalgia (44%), and general musculoskeletal pain have been reported.

Other

Other side effects have included reports of jaw pain in 54% of patients on chronic infusions. Chills, fever, sepsis, and flu-like symptoms have been reported in 25% of patients. Ascites and pleural effusions have been reported. Adverse effects due to mechanical problems with the infusion pump have occurred. Tachyphylaxis, defined as an increased requirement for epoprostenol (the active ingredient contained in Flolan) over time (due to tolerance to the drug and not due to disease progression) has been reported. In general, doses of epoprostenol will need to be increased routinely.

Barst et al (1994) reported that 5 of 18 patients experienced 8 mechanical problems, including pump malfunction, and problems with syringe, tubing and catheter systems. When the epoprostenol was temporarily discontinued to remedy the problems, the patients experienced increased pulmonary hypertension symptoms, including syncope. One episode was fatal. Clotting occurred 9 times in 5 patients. One episode, resulting in sepsis, was fatal.

Jones and colleagues report the occurrence of sterile ascites in 3 patients during long-term epoprostenol treatment. Protein content and aspartate aminotransferases levels were elevated. In 2 patients the ascites was recurrent. Death occurred in one patient whose ascites was chylous (thick milky-white or pale yellow appearance).

Hematologic

Hematologic side effects have included reports of sepsis, usually due to infections from the indwelling catheter tip. Thrombocytopenia has been observed during uncontrolled clinical trials; however, it is not known if clinically significant bleeding occurred due to thrombocytopenia.

Barst and colleagues (1994) reported 7 episodes of nonfatal sepsis due to catheter tips in 3 of 18 patients receiving epoprostenol for primary pulmonary hypertension. One patient died due to sepsis after a thrombus was removed from the catheter. Jones and colleagues report that 3 of 10 patients acquired septicemia due to catheter tip infections. In each case, subjective wellbeing and exercise capacity decreased. Antibiotics were effective; however, in one patient a peripheral line had to be placed until the infection cleared.

Endocrine

Endocrine side effects have included rare reports of sweating during acute dosing.

Respiratory

Respiratory side effects have included rare report of dyspnea during acute dosing. Additional side effects have included hypoxia and pulmonary edema.

Local

Local side effects have included injection site pain (13%) and local infection (21%).

Peripheral venous local reactions (bright red veins, induration, tenderness) have been noted with epoprostenol infusion, but have resolved within 30 minutes after discontinuation of the infusion. The high pH of the buffer may have been responsible.

Psychiatric

Psychiatric side effects have included reports of depression.

Psychiatric side effects have included reports of depression in women receiving epoprostenol infusions for Raynaud's phenomenon or systemic sclerosis. Antidepressant therapy was successful in several cases.

Ocular

Ocular side effects have included reports of photosensitivity.

Dermatologic

Dermatologic side effects have included rash.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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