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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Virazole Solution:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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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.

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Side Effects by Body System - for Healthcare Professionals

General

The most common serious or life-threatening side effects induced or aggravated by ribavirin tablets in combination with peginterferon alfa-2a have included depression, suicide, relapse of drug abuse/overdose, and bacterial infections in less than 1% of patients and hepatic decompensation in 2% of chronic hepatitis C (CHC)-HIV coinfected patients. The most common serious side effect in CHC monoinfected (3%) and CHC-HIV coinfected (5%) patients receiving peginterferon alfa-2a alone or in combination with ribavirin tablets was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Common side effects reported in CHC-HIV coinfected patients receiving ribavirin tablets in combination with peginterferon alfa-2a have included neutropenia, anemia, thrombocytopenia, weight decrease, and mood alteration.

The most common side effects reported in patients receiving ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b were injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability. The most common serious side effects associated with peginterferon alfa-2b in combination with ribavirin capsules/oral solution were depression and suicidal ideation in less than 1% of patients. The most common fatal side effects reported in patients receiving peginterferon alfa-2b in combination with ribavirin capsules/oral solution were cardiac arrest, suicidal ideation, and suicide attempt in less than 1% of patients.

Respiratory

Mechanically ventilated patients may be predisposed to respiratory deterioration.

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.

Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.

Respiratory side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included dyspnea (up to 26%), cough (up to 23%), and exertional dyspnea (up to 7%). Pharyngitis (up to 13%), rhinitis (up to 8%), and sinusitis (up to 12%) have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Pulmonary symptoms (including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and fatal pneumonia), sarcoidosis, and exacerbation of sarcoidosis have been reported with oral ribavirin in combination with alpha interferon. Pulmonary hypertension has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Significant deterioration of pulmonary function in patients with chronic obstructive pulmonary disease or asthma and minor pulmonary function abnormalities in healthy volunteers have been reported with aerosolized ribavirin. Asthmatic patients have also reported dyspnea and chest soreness with aerosolized ribavirin. Worsening of respiratory status, bronchospasm, hypoventilation, cyanosis, dyspnea, bronchoconstriction, bacterial pneumonia, cough, pneumothorax, pulmonary edema, apnea, atelectasis, hypoxia, and ventilator dependence have been reported with aerosolized ribavirin. Rhinitis and pharyngitis, as well as several cases of bronchospasm and/or chest pain (usually in individuals with underlying reactive airway disease), have been reported in health care workers exposed to aerosolized ribavirin.

Hypersensitivity

Hypersensitivity side effects have included reactions such as urticaria, angioedema, bronchoconstriction, and anaphylaxis in patients treated with alfa interferon and ribavirin. Severe skin reactions (including vesiculobullous eruptions, Stevens-Johnson syndrome, erythema multiforme, and exfoliative dermatitis/erythroderma) have been reported in patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. 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 (up to 36%), pruritus (up to 29%), dermatitis (up to 16%), dry skin (up to 24%), increased sweating (up to 11%), rash (up to 34%), and eczema (up to 5%) have been associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Grover's disease has been reported in a 55-year-old man 2 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. Skin disorders associated with ribavirin tablets in combination with peginterferon alfa-2a have included lichenoid eruptions and maculopapular rashes. Rash has been reported in patients treated with and health care workers exposed to aerosolized ribavirin. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a.

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.

Rash associated with aerosolized ribavirin usually resolved within hours of stopping treatment in patients and within minutes to hours of stopping close exposure in health care workers.

Cardiovascular

Cardiovascular side effects have included angina, arrhythmia, and pulmonary embolism in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Fatal and nonfatal myocardial infarctions have been reported in patients with anemia due to ribavirin capsules/oral solution. Cardiac arrest, hypotension, bradycardia, bigeminy, tachycardia, hypertension (usually slight increases in blood pressure), and digitalis toxicity have been reported with aerosolized ribavirin.

Bigeminy, bradycardia, and tachycardia have been reported in patients with underlying congenital heart disease.

Hematologic

Hemolytic anemia is the primary toxicity of ribavirin therapy. Hemoglobin levels generally declined within the first 1 to 2 weeks of oral therapy. Cardiac and pulmonary adverse effects associated with anemia have been reported in 10% of patients.

Hemoglobin less than 10 g/dL was reported in 13% of patients receiving ribavirin tablets in combination with peginterferon alfa-2a. Additional laboratory abnormalities during treatment with ribavirin tablets in combination with peginterferon alfa-2a or interferon alfa-2b have included decreased neutrophils (1000 to less than 1500 cells/mm3: up to 38%; 500 to less than 1000 cells/mm3: up to 49%; less than 500 cells/mm3: up to 5%), platelets (50,000 to less than 75,000 cells/mm3: up to 11%; 20,000 to less than 50,000 cells/mm3: up to 5%), and hemoglobin (8.5 to 9.9 g/dL: 11%; less than 8.5 g/dL: up to 2%).

Changes in laboratory values during treatment with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b have included decreased hemoglobin (9.5 to 10.9 g/dL: up to 32%; 8 to 9.4 g/dL: up to 5%; 6.5 to 7.9 g/dL: up to 0.2%), leukocytes [2 to 2.9 x 10(9)/L: up to 46%; 1.5 to 1.9 x 10(9)/L: up to 24%; 1 to 1.4 x 10(9)/L: up to 5%], neutrophils [1 to 1.49 x 10(9)/L: up to 42%; 0.75 to 0.99 x 10(9)/L: up to 25%; 0.5 to 0.74 x 10(9)/L: up to 18%; less than 0.5 x 10(9)/L: up to 11%], and platelets [70 to 99 x 10(9)/L: up to 15%; 50 to 69 x 10(9)/L: up to 3%; 30 to 49 x 10(9)/L: up to 0.2%; less than 30 x 10(9)/L: up to 1%].

Hematologic side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included anemia (up to 35%), lymphopenia (up to 14%), neutropenia (up to 40%), thrombocytopenia (up to 8%), and leukopenia (up to 10%). Hemolytic anemia is the most significant toxicity of ribavirin. Aplastic anemia and thrombotic thrombocytopenic purpura have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Pancytopenia (marked decreases in red blood cells, neutrophils, and platelets) and bone marrow suppression have been reported following concomitant administration of pegylated interferon plus oral ribavirin and azathioprine. Aplastic anemia has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Pure red cell aplasia has been reported during postmarketing experience with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Cases of anemia (type unspecified), reticulocytosis, and hemolytic anemia associated with aerosolized ribavirin have been reported during postmarketing experience and have been reversible with drug discontinuation.

Ocular

Ocular side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included blurred vision (up to 6%). Corneal ulcer has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Conjunctivitis (up to 5%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Serous retinal detachment has been reported during postmarketing experience with oral ribavirin in combination with peginterferon alfa-2a, interferon alfa-2b, or peginterferon alfa-2b. Eye irritation and conjunctivitis have been reported in patients treated with and health care workers exposed to aerosolized ribavirin. Lacrimation has been reported in health care workers exposed to aerosolized ribavirin. Damage to contact lenses after prolonged close exposure to aerosolized ribavirin has also been reported.

Conjunctivitis associated with aerosolized ribavirin usually resolved within hours of stopping treatment in patients. Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.

Eye and conjunctival irritation resolved spontaneously when the caregivers left the hospital. In five of six cases, the caregivers were wearing contact lenses. After the staff stopped wearing contact lenses while caring for patients receiving aerosolized ribavirin, the reactions did not occur.

Gastrointestinal

Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.

Gastrointestinal side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included nausea (up to 47%), nausea and vomiting (up to 29%), diarrhea (up to 22%), vomiting (up to 14%), abdominal pain (up to 13%), dry mouth (up to 12%), dyspepsia (up to 16%), and constipation (5%). Peptic ulcer, gastrointestinal bleeding, pancreatitis, and colitis have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Nausea has been reported in health care workers exposed to aerosolized ribavirin.

Musculoskeletal

Musculoskeletal side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included myalgia (up to 64%), arthralgia (up to 34%), musculoskeletal pain (up to 28%), and back pain (5%). Myositis has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. At least 6 cases of mild to moderate gout have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.

Nervous system

Nervous system side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included headache (up to 66%), dizziness (excluding vertigo; 26%), and memory impairment (up to 6%). Peripheral neuropathy, coma, and cerebral hemorrhage have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Taste perversion (up to 9%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Hearing impairment and hearing loss have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a. Vertigo and hearing disorder have been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Headache and dizziness have been reported in health care workers exposed to aerosolized ribavirin. Seizures have been reported with experimental intravenous ribavirin.

Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.

Metabolic

Metabolic side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included anorexia (up to 32%) and weight decrease (up to 29%). Diabetes mellitus has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Falsely low hemoglobin A1c levels have been reported. Dehydration has been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a. Diabetes has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b.

Falsely low hemoglobin A1c levels may be due to ribavirin-induced hemolysis decreasing the number of circulating glycosylated hemoglobin molecules.

Psychiatric

Psychiatric side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included irritability/anxiety/nervousness/emotional lability (up to 47%), insomnia (up to 41%), depression (up to 36%), concentration impairment (up to 21%), mood alteration (up to 9%), and agitation (up to 8%). Suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse/overdose, psychotic disorder, and hallucination have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Impairment of desire and the potential to affect sexual satisfaction have been reported with ribavirin tablets in combination with peginterferon alfa-2a in male patients.

Endocrine

Endocrine side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included hypothyroidism (up to 5%).

Other

Other side effects frequently associated with ribavirin tablets in combination with peginterferon alfa-2a have included influenza-like symptoms (such as fatigue, pyrexia, myalgia, headache, and rigors). Fatigue/asthenia (up to 70%), pyrexia (up to 55%), rigors (up to 48%), chills (up to 39%), influenza-like illness (up to 18%), unspecified pain (up to 13%), right upper quadrant pain (up to 12%), pain (up to 10%), chest pain (up to 9%), and malaise (up to 6%) have been associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Hyperuricemia (in association with hemolysis; up to 38%) and flushing (up to 4%) have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Asthenia has been reported with experimental intravenous ribavirin.

Hepatic

Hepatic side effects have included hepatic dysfunction, fatty liver, and cholangitis in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Hepatic decompensation has been reported in 2% of CHC-HIV coinfected patients receiving peginterferon alfa-2a in combination with ribavirin tablets. Hyperbilirubinemia (in association with hemolysis; up to 14%), hepatomegaly (4%), and increased ALT have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.

Changes in laboratory values during treatment with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b have included increased total bilirubin (1.5 to 3 mg/dL: up to 32%; 3.1 to 6 mg/dL: up to 3%; 6.1 to 12 mg/dL: up to 0.4%) and ALT (2 x baseline: up to 0.6%; 2.1 to 5 x baseline: up to 3%).

Immunologic

Immunologic side effects associated with peginterferon alfa-2a alone or in combination with ribavirin tablets have included bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia) in 3% of CHC and 5% of CHC-HIV patients and autoimmune phenomena (such as hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis) in less than 1% of patients. Resistance mechanism disorders (overall: up to 12%), including viral infection (12%) and fungal infection (up to 6%), have been associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Liver and renal graft rejections have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a.

Genitourinary

Genitourinary side effects associated with ribavirin tablets in combination with peginterferon alfa-2a have included sexual dysfunction in male patients. Menstrual disorder has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.

Local

Local side effects have included injection site reactions (up to 58%) in patients treated with oral ribavirin in combination with interferon alfa-2b, peginterferon alfa-2b, or peginterferon alfa-2a. Injection site inflammation (up to 25%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Skin disorders associated with ribavirin tablets in combination with peginterferon alfa-2a 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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