Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 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 ribavirin for inhalation solution, USP conducted in 1989-
Additional data from spontaneous post-marketing reports of adverse events in individual patients have been available since
Deaths Deaths during or shortly after treatment with aerosolized ribavirin for inhalation solution, USP have been reported in 20 cases of patients treated with ribavirin for inhalation solution, USP (12 of these patients were being treated for RSV infections).
Several cases have been characterized as "possibly related" to ribavirin for inhalation solution, USP 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 ribavirin for inhalation solution, USP 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 ribavirin for inhalation solution, USP 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.
WARNINGS SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS.
Respiratory function should be carefully monitored during treatment.
If initiation of aerosolized ribavirin for inhalation solution, USP treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitant administration of bronchodilators.
Use with Mechanical Ventilators USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED.
Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.
Like all medications, Ribavirin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: