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Virazole

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Virazole

Virazole Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Virazole (ribavirin) for Inhalation Solution is an antiviral drug used to treat infants and young children who have a severe lung infection caused by the respiratory syncytial virus-RSV. It is not recommended for use in adults. Common side effects include chest soreness. Redness/irritation of the eye or eyelid may also occur.

The dose of Virazole is determined by a physician and the drug is administered in a medical setting. Virazole may interact with HIV/AIDs medications. Tell your doctor all medications and supplements your child uses. This product is not usually used in adults and is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have questions.

Our Virazole (ribavirin) for Inhalation Solution 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 Overview?

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

Virazole Overview - Patient Information: Side Effects

SIDE EFFECTS: Chest soreness may occur. Redness/irritation of the eye or eyelid may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

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

Tell the doctor immediately if any of these unlikely but serious side effects occur: pale/bluish skin around the mouth/lips/fingernails, worsening of breathing trouble, slow/fast/irregular heartbeat.

Tell the doctor immediately if any of these rare but very serious side effects occur: fainting, seizure.

This medication may infrequently cause anemia, usually within 1 to 2 weeks after treatment is started. Tell the doctor immediately if you notice any symptoms of anemia such as unusual tiredness or fast/pounding heartbeat.

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 the 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 Virazole (Ribavirin)»

What is Prescribing information?

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

Virazole FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The description of adverse reactions is based on events from clinical studies (approximately 200 patients) conducted prior to 1986, and the controlled trial of aerosolized VIRAZOLE (ribavirin) conducted in 1989-1990. Additional data from spontaneous post-marketing reports of adverse events in individual patients have been available since 1986.

Deaths

Deaths during or shortly after treatment with aerosolized VIRAZOLE (ribavirin) have been reported in 20 cases of patients treated with VIRAZOLE (ribavirin) (12 of these patients were being treated for RSV infections). Several cases have been characterized as "possibly related" to VIRAZOLE (ribavirin) by the treating physician; these were in infants who experienced worsening respiratory status related to bronchospasm while being treated with the drug. Several other cases have been attributed to mechanical ventilator malfunction in which VIRAZOLE (ribavirin) precipitation within the ventilator apparatus led to excessively high pulmonary pressures and diminished oxygenation. In these cases the monitoring procedures described in the current package insert were not employed (see Description of Studies, WARNINGS, and DOSAGE AND ADMINISTRATION).

Pulmonary and Cardiovascular

Pulmonary function significantly deteriorated during aerosolized VIRAZOLE (ribavirin) treatment in six of six adults with chronic obstructive lung disease and in four of six asthmatic adults. Dyspnea and chest soreness were also reported in the latter group. Minor abnormalities in pulmonary function were also seen in healthy adult volunteers.

In the original study population of approximately 200 infants who received aerosolized VIRAZOLE (ribavirin) , several serious adverse events occurred in severely ill infants with life-threatening underlying diseases, many of whom required assisted ventilation. The role of VIRAZOLE (ribavirin) in these events is indeterminate. Since the drug's approval in 1986, additional reports of similar serious, though non-fatal, events have been filed infrequently. Events associated with aerosolized VIRAZOLE (ribavirin) use have included the following:

Pulmonary: Worsening of respiratory status, bronchospasm, pulmonary edema, hypoventilation, cyanosis, dyspnea, bacterial pneumonia, pneumothorax, apnea, atelectasis and ventilator dependence.

Cardiovascular: Cardiac arrest, hypotension, bradycardia and digitalis toxicity. Bigeminy, bradycardia and tachycardia have been described in patients with underlying congenital heart disease.

Some subjects requiring assisted ventilation experienced serious difficulties, due to inadequate ventilation and gas exchange. Precipitation of drug within the ventilatory apparatus, including the endotracheal tube, has resulted in increased positive end expiratory pressure and increased positive inspiratory pressure. Accumulation of fluid in tubing ("rain out") has also been noted. Measures to avoid these complications should be followed carefully (see DOSAGE AND ADMINISTRATION).

Hematologic

Although anemia was not reported with use of aerosolized VIRAZOLE (ribavirin) in controlled clinical trials, most infants treated with the aerosol have not been evaluated 1 to 2 weeks post-treatment when anemia is likely to occur. Anemia has been shown to occur frequently with experimental oral and intravenous VIRAZOLE (ribavirin) in humans. Also, cases of anemia (type unspecified), reticulocytosis and hemolytic anemia associated with aerosolized VIRAZOLE (ribavirin) use have been reported through post-marketing reporting systems. All have been reversible with discontinuation of the drug.

Other

Rash and conjunctivitis have been associated with the use of aerosolized VIRAZOLE (ribavirin) . These usually resolve within hours of discontinuing therapy. Seizures and asthenia associated with experimental intravenous VIRAZOLE (ribavirin) therapy have also been reported. Adverse Events in Health Care Workers Studies of environmental exposure to aerosolized VIRAZOLE (ribavirin) in health care workers administering care to patients receiving the drug have not detected adverse signs or symptoms related to exposure. However, 152 health care workers have reported experiencing adverse events through post-marketing surveillance. Nearly all were in individuals providing direct care to infants receiving aerosolized VIRAZOLE (ribavirin) . Of 358 events from these 152 individual health care worker reports, the most common signs and symptoms were headache (51% of reports), conjunctivitis (32%), and rhinitis, nausea, rash, dizziness, pharyngitis, or lacrimation (10-20% each). Several cases of bronchospasm and/or chest pain were also reported, usually in individuals with known underlying reactive airway disease. Several case reports of damage to contact lenses after prolonged close exposure to aerosolized VIRAZOLE (ribavirin) have also been reported. Most signs and symptoms reported as having occurred in exposed health care workers resolved within minutes to hours of discontinuing close exposure to aerosolized VIRAZOLE (ribavirin) (also see Information for Health Care Personnel).

The symptoms of RSV in adults can include headache, conjunctivitis, sore throat and/or cough, fever, hoarseness, nasal congestion and wheezing, although RSV infections in adults are typically mild and transient. Such infections represent a potential hazaid to uninfected hospital patients. It is unknown whether certain symptoms cited in reports from health care workers were due to exposure to the drug or infection with RSV. Hospitals should implement appropriate infection control procedures.

Read the entire FDA prescribing information for Virazole (Ribavirin) »

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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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