Virazole

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/15/2021
Virazole Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Virazole?

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). Virazole is not recommended for use in adults.

What Are Side Effects of Virazole?

Common side effects of Virazole include:

  • chest soreness,
  • redness/irritation of the eye or eyelid,
  • pinkeye (conjunctivitis),
  • breathing problems,
  • irregular heartbeat,
  • lung infections, or
  • rash

Dosage for Virazole

The dose of Virazole is determined by a physician and the drug is administered in a medical setting.

What Drugs, Substances, or Supplements Interact with Virazole?

Virazole may interact with HIV/AIDs medications. Tell your doctor all medications and supplements your child uses.

Virazole During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

Which illness is known as a viral upper respiratory tract infection? See Answer
Virazole Consumer Information

Get emergency medical help if your baby has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Your baby will remain under constant supervision during treatment with ribavirin inhalation. Any problems the baby has during this time may require further treatment by healthcare professionals.

Sudden breathing problems may occur. Tell your baby's caregivers at once if the baby has any of these side effects:

  • fever, cough;
  • shallow breathing;
  • limpness or severe weakness;
  • wheezing, gasping for breath;
  • blue-colored lips, cold and clammy skin;
  • cough with mucus; or
  • other worsened breathing problems.

Although it may be unlikely, it is possible that ribavirin inhalation could be released into the air in amounts high enough to cause side effects in people who have close contact with the child receiving this medicine. Tell your doctor if you have any of these side effects while caring for the child:

  • chest pain, shortness of breath;
  • runny nose, sore throat;
  • headache, dizziness;
  • nausea;
  • rash; or
  • eye redness, watery eyes.

Some symptoms of exposure to airborne ribavirin in an adult may be similar to the symptoms of infection with RSV. Report any new symptoms to the doctor right away.

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 Virazole (Ribavirin)

SLIDESHOW

A Cold or The Flu? How to Tell the Difference See Slideshow
Virazole Professional Information

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)

© Virazole Patient Information is supplied by Cerner Multum, Inc. and Virazole Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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