Virazole Side Effects

Generic Name: ribavirin

Please note - some side effects for Virazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Virazole - for the Consumer

Virazole Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Virazole Solution:

Eye redness or irritation.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast, slow, or irregular heartbeat; increased trouble breathing.

Virazole Side Effects - for the Professional

Virazole

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 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 have been reported in 20 cases of patients treated with Virazole (12 of these patients were being treated for RSV infections). Several cases have been characterized as “possibly related” to Virazole 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 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.

Pulmonary and Cardiovascular

Pulmonary function significantly deteriorated during aerosolized Virazole 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, several serious adverse events occurred in severely ill infants with life-threatening underlying diseases, many of whom required assisted ventilation. The role of Virazole 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 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.

Hematologic

Although anemia was not reported with use of aerosolized Virazole 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 in humans. Also, cases of anemia (type unspecified), reticulocytosis and hemolytic anemia associated with aerosolized Virazole 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. These usually resolve within hours of discontinuing therapy. Seizures and asthenia associated with experimental intravenous Virazole therapy have also been reported.

Adverse Events in Health Care Workers

Studies of environmental exposure to aerosolized Virazole 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. 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 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 (also seeInformation 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 hazard 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.

Side Effects by Body System

General

The most common life-threatening or fatal side effects associated with ribavirin-peginterferon therapy have included depression, suicide, relapse of drug abuse/overdose, bacterial infections, and hepatic decompensation.

The most common serious side effects in CHC monoinfected and CHC-HIV coinfected patients have included bacterial infections.

Common side effects reported in CHC-HIV coinfected patients receiving ribavirin-peginterferon have included neutropenia, anemia, thrombocytopenia, weight, decrease, and mood alteration.

Side effects with aerosolized ribavirin are rare.

Respiratory

Patients with chronic obstructive pulmonary disease or asthma receiving aerosolized ribavirin have been reported to experience deterioration of pulmonary functions, dyspnea, and chest soreness. Mechanically ventilated patients may also be predisposed to respiratory deterioration. Minor changes in pulmonary function tests have been reported in healthy volunteers receiving aerosolized ribavirin.

Health experts recommend the use of aerosol containment systems with all types of ribavirin administration units except mechanical ventilators.

Severe hypoxia was described in a case report of a previously healthy infant who experienced a dramatic drop in transcutaneous oxygen within 1 minute of receiving ribavirin. Oxygen levels returned to normal promptly following discontinuation of therapy. However, the infant later died, and postmortem examination revealed a high pulmonary arterial pressure and a patent ductus arteriosus. A definitive causal relationship was not established, and equipment failure was not specifically ruled out by the authors.

Respiratory side effects have included worsening of respiratory status, hypoventilation, cyanosis, dyspnea, and bronchoconstriction in patients receiving aerosolized ribavirin therapy and are more common in patients with underlying respiratory or cardiopulmonary diseases. Bronchoconstriction is generally transient and may easily be reversed with bronchodilator therapy. Bacterial pneumonia, cough, pneumothorax, pulmonary edema, apnea, atelectasis and ventilator dependence has also been reported.

Hypersensitivity

Hypersensitivity side effects have included reactions such as urticaria, angioedema, bronchoconstriction, and anaphylaxis in patients treated with alfa interferon and ribavirin and have been reported rarely. Severe skin reactions (including vesiculobullous eruptions, Stevens-Johnson syndrome, erythema multiforme, and exfoliative dermatitis/erythroderma) have been rarely reported in patients treated with peginterferon alfa-2a alone and with ribavirin. Serious skin reactions have been reported during postmarketing experience in patients treated with peginterferon alfa-2a.

Dermatologic

Dermatologic side effects have included rash and skin irritation from prolonged drug contact. Alopecia, pruritus, dermatitis, and dry skin have been reported with higher frequency. Grover's disease has been reported in a 55-year-old man two weeks after the start of ribavirin therapy. A photoallergic skin reaction was reported to occur 4 months after initiation of ribavirin treatment, and recurred approximately 24 hours after reexposure to ribavirin. Increased sweating, rash, and eczema have been reported. Skin disorders associated with oral ribavirin and peginterferon alfa-2a combination therapy have included lichenoid eruptions and maculopapular rashes.

Grover's disease (suprabasal transient acantholytic dermatosis) secondary to ribavirin use was confirmed upon drug rechallenge in a 55-year-old man with chronic active hepatitis C.

Cardiovascular

Cardiovascular side effects have been reported rarely with aerosolized ribavirin. These have included cardiac arrest, hypotension, hypertension (usually slight increases in blood pressure), and digitalis toxicity. Bigeminy, bradycardia, and tachycardia have been reported in patients with underlying congenital heart disease. Angina, arrhythmia, and pulmonary embolism have been reported in patients treated with peginterferon alfa-2a alone or with ribavirin.

Hematologic

Hematologic side effects have been reported the most frequently with the use of oral and intravenous ribavirin. These have included hemolytic anemia, anemia, lymphopenia, neutropenia, thrombocytopenia, and thrombotic thrombocytopenic purpura. Aplastic anemia and pure red cell aplasia have been reported during postmarketing experience of oral ribavirin in combination with recombinant interferon alfa-2b or recombinant peginterferon alfa-2b. Postmarketing adverse events associated with aerosolized ribavirin have included cases of anemia (unspecified), reticulocytosis, and hemolytic anemia.

Hemolytic anemia is the primary toxicity of ribavirin therapy. Hemoglobin levels generally declined within the first one to two weeks of oral therapy. Cardiac and pulmonary adverse effects associated with anemia have been reported in 10% of patients.

Ocular

The eye and conjunctival irritation resolved spontaneously when the care givers left the hospital. In five of six cases, the care givers were wearing contact lenses. After the staff stopped wearing the lenses while caring for these patients, the reactions did not occur.

Ocular side effects associated with aerosolized ribavirin have included eye irritation and conjunctivitis in patients and their caregivers. Blurred vision has been reported with the use of oral ribavirin (in combination with peginterferon alfa). Corneal ulcer has been reported in patients treated with peginterferon alfa-2a alone or with ribavirin. Serious retinal detachment has been reported during postmarketing experience in patients treated with peginterferon alfa-2a.

Gastrointestinal

Gastrointestinal side effects have been reported frequently with the use of oral ribavirin (in combination with peginterferon alfa). These have included nausea and vomiting, diarrhea, abdominal pain, dry mouth, and dyspepsia. Peptic ulcer, gastrointestinal bleeding, pancreatitis, and colitis have been reported in patients treated with peginterferon alfa-2a alone or with ribavirin.

Musculoskeletal

Musculoskeletal side effects have been reported frequently with the use of oral ribavirin (in combination with peginterferon alfa). These have included myalgia, arthralgia, and back pain. Myositis has been reported in patients treated with peginterferon alfa-2a alone or with ribavirin.

Nervous system

Nervous system side effects have been reported frequently with the use of oral ribavirin (in combination with peginterferon alfa). These have included headache, dizziness (excluding vertigo), and memory impairment. Vertigo and hearing disorder have been reported during postmarketing experience of oral ribavirin in combination with recombinant interferon alfa-2b or recombinant peginterferon alfa-2b. Peripheral neuropathy and cerebral hemorrhage have been reported in patients treated with peginterferon alfa-2a alone or with ribavirin. Hearing impairment and hearing loss have been reported during postmarketing experience in patients treated with peginterferon alfa-2a.

Metabolic

Metabolic side effects have been reported frequently with the use of oral ribavirin (in combination with peginterferon alfa). These have included anorexia and weight decrease. Diabetes mellitus has been reported in patients treated with peginterferon alfa-2a alone or with ribavirin. Falsely low hemoglobin A1c levels have been reported. Dehydration has been reported during postmarketing experience in patients treated with peginterferon alfa-2a.

Psychiatric

Psychiatric side effects have been reported frequently with the use of oral ribavirin (in combination with peginterferon alfa). These have included irritability, anxiety, nervousness, insomnia, depression, concentration impairment, and mood alteration. Suicide, suicidal ideation, psychosis, aggression, psychotic disorder, and hallucination have been reported in patients treated with peginterferon alfa-2a alone or with ribavirin.

Endocrine

Endocrine side effects have included hypothyroidism.

Other

Other side effects have included fatigue, asthenia, pyrexia, rigors, influenza-like symptoms, and pain. Coma has been reported in patients treated with peginterferon alfa-2a alone or with ribavirin.

Immunologic

Immunologic side effects have included autoimmune phenomena such as hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, and rheumatoid arthritis in patients treated with peginterferon alfa-2a alone or with ribavirin.

Local

Local side effects have included injection site reactions in patients treated with oral ribavirin in combination with interferon alfa-2b or peginterferon alfa-2a. Skin disorders associated with oral ribavirin and peginterferon alfa-2a combination therapy have included cutaneous necrosis at peginterferon alfa-2a injection sites. Hyperpigmentation around/over peginterferon alfa-2a injection sites has been reported.

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