Ribavirin Side Effects

Brand Names: Rebetol, Virazole, Ribasphere, Copegus

Please note - some side effects for Ribavirin 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 Ribavirin - for the Consumer

Ribavirin

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 Ribavirin:

Blurred vision; cough; diarrhea; dizziness; dry mouth; dry skin; hair loss; joint pain; loss of appetite; mild headache, nausea, or vomiting; tiredness; trouble sleeping; upset stomach; weakness or fatigue.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in vision or speech; chest pain; confusion; dark urine; decrease in the amount of urine; depression; fever, chills, or sore throat; irregular heartbeat; memory problems; muscle pain or weakness; numbness or tingling of arms or legs; one-sided weakness; prolonged nausea and vomiting; rapid breathing; severe headache, dizziness, or vomiting; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit that looks like coffee grounds; weight loss; yellowing of eyes or skin.

Ribavirin Capsules

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 Ribavirin Capsules:

Cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; tiredness; upset stomach; weakness or fatigue.

Severe allergic reactions (rash; hives; itching; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in hearing, taste, or vision; chest pain; dark urine; decrease in the amount of urine; fever, chills, or sore throat; hair loss; irregular heartbeat; joint pain; muscle pain or weakness; numbness or tingling of arms or legs; prolonged nausea and vomiting; rapid breathing; severe headache; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; trouble sleeping; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit that looks like coffee grounds; weight loss; yellowing of eyes or skin.

Ribavirin 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 Ribavirin Solution:

Cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; tiredness; upset stomach; weakness or fatigue

Severe allergic reactions (rash; hives; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in hearing, taste, or vision; chest pain; dark urine; decrease in the amount of urine; fever, chills, or sore throat; hair loss; irregular heartbeat; joint pain; loss of appetite; muscle pain or weakness; numbness or tingling of arms or legs; prolonged nausea and vomiting; rapid breathing; severe headache; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; trouble sleeping; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit that looks like coffee grounds; weight loss; yellowing of eyes or skin.

Ribavirin Side Effects - for the Professional

Ribavirin

Peginterferon alfa-2a in combination with Ribavirin causes a broad variety of serious adverse reactions.

The most common life-threatening or fatal events induced or aggravated by peginterferon alfa-2a and Ribavirin were depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of < 1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV patients.

In all studies, one or more serious adverse reactions occurred in 10% of CHC monoinfected patients and in 19% of CHC/HIV patients receiving peginterferon alfa-2a alone or in combination with Ribavirin. The most common serious adverse event (3% in CHC and 5% in CHC/HIV) was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other SAEs occurred at a frequency of < 1% and included: suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination.

Nearly all patients in clinical trials experienced one or more adverse events. The most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus.

Ten percent of CHC monoinfected patients receiving 48 weeks of therapy with peginterferon alfa-2a in combination with Ribavirin discontinued therapy; 16% of CHC/HIV coinfected patients discontinued therapy. The most common reasons for discontinuation of therapy were psychiatric, flu-like syndrome (e.g., lethargy, fatigue, headache), dermatologic and gastrointestinal disorders and laboratory abnormalities (thrombocytopenia, neutropenia, and anemia).

Overall 39% of patients with CHC or CHC/HIV required modification of peginterferon alfa-2a and/or Ribavirin therapy. The most common reason for dose modification of peginterferon alfa-2a in CHC and CHC/HIV patients was for laboratory abnormalities; neutropenia (20% and 27%, respectively) and thrombocytopenia (4% and 6%, respectively). The most common reason for dose modification of Ribavirin in CHC and CHC/HIV patients was anemia (22% and 16%, respectively).

Peginterferon alfa-2a dose was reduced in 12% of patients receiving 1000 mg to 1200 mg Ribavirin for 48 weeks and in 7% of patients receiving 800 mg Ribavirin for 24 weeks. Ribavirin dose was reduced in 21% of patients receiving 1000 mg to 1200 mg Ribavirin for 48 weeks and in 12% of patients receiving 800 mg Ribavirin for 24 weeks.

Chronic hepatitis C monoinfected patients treated for 24 weeks with peginterferon alfa-2a and 800 mg Ribavirin were observed to have lower incidence of serious adverse events (3% vs. 10%), hemoglobin < 10 g/dL (3% vs. 15%), dose modification of peginterferon alfa-2a (30% vs. 36%) and Ribavirin (19% vs. 38%), and of withdrawal from treatment (5% vs. 15%) compared to patients treated for 48 weeks with peginterferon alfa-2a and 1000 mg or 1200 mg Ribavirin. On the other hand, the overall incidence of adverse events appeared to be similar in the two treatment groups.

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug. Also, the adverse event rates listed here may not predict the rates observed in a broader patient population in clinical practice.

Common Adverse Reactions in CHC With HIV Coinfection

The adverse event profile of coinfected patients treated with peginterferon alfa-2a and Ribavirin in Study NR15961 was generally similar to that shown for monoinfected patients in Study NV15801 (Table 4). Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%), and mood alteration (9%).

Laboratory Test Values

Anemia due to hemolysis is the most significant toxicity of Ribavirin therapy. Anemia (hemoglobin < 10 g/dL) was observed in 13% of all Ribavirin and peginterferon alfa-2a combination-treated patients in clinical trials. The maximum drop in hemoglobin occurred during the first 8 weeks of initiation of Ribavirin therapy.

Postmarketing Experience

The following adverse reactions have been identified and reported during post-approval use of peginterferon alfa-2a therapy: dehydration, hearing impairment, hearing loss, and serious skin reactions.

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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