Chemical formula: C₈H₁₂N₄O₅ Molecular mass: 244.205 g/mol PubChem compound: 37542
Ribavirin interacts in the following cases:
The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients. Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin. Adult patients with moderate renal impairment (creatinine clearance of 30-50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg. Adult patients with severe renal impairment (creatinine clearance of <30 mL/minute) and patients with End Stage Renal Disease (ESRD) or on haemodialysis should be administered ribavirin 200 mg/day. The table below provides guidelines for dose modification for patients with renal dysfunction.
Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia. No data are available regarding dose modification for paediatric patients with renal impairment.
Dosage Modification for Renal Impairment in Adult Patients:
| Creatinine Clearance | Ribavirin Dose (daily) |
|---|---|
| 30 to 50 mL/min | Alternating doses, 200 mg and 400 mg every other day |
| Less than 30 mL/min | 200 mg daily |
| Haemodialysis (ESRD) | 200 mg daily |
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%. It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH. This interaction is not considered to be clinically relevant.
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis. Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro. This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir). Co-administration of ribavirin and didanosine is not recommended. Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported.
Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis.
Teratogenicity: Significant teratogenic and/or embryocidal potential have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose.
Genotoxicity: Ribavirin induces genotoxicity.
Conflicting findings are reported in literature on co-administration between abacavir and ribavirin. Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy. Caution should be exercised when both medicines are co-administered.
Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine. The use of pegylated alpha interferons and ribavirin concomitantly with azathioprine should be avoided.
In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close hematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicines should be stopped.
The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated. The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia. Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established. This would be particularly important in patients with a known history of zidovudine induced anaemia.
Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa/ribavirin treatment. In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death. Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment. Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin for discontinuation or dose modification recommendations. Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients. Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients. Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended.
In patients co-infected with HCV/HIV, limited efficacy and safety data (N=25) are available in subjects with CD4 counts less than 200 cells/µL. Caution is therefore warranted in the treatment of patients with low CD4 counts.
Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin.
If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, ribavirin must be discontinued immediately and appropriate medical therapy instituted. Transient rashes do not necessitate interruption of treatment.
The use of ribavirin is contraindicated during pregnancy. Ribavirin has been shown in preclinical studies to be teratogenic and genotoxic.
It is not known whether ribavirin is excreted in human milk. Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Ribavirin must not be used by females who are pregnant. Extreme care must be taken to avoid pregnancy in female patients. Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Females of childbearing potential must use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time. If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus.
Extreme care must be taken to avoid pregnancy in partners of male patients taking ribavirin. Ribavirin accumulates intracellularly and is cleared from the body very slowly. It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus. Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with ribavirin and for seven months after treatment. Routine monthly pregnancy tests must be performed during this time. Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis.
Teratogenicity: Significant teratogenic and/or embryocidal potential have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose.
Genotoxicity: Ribavirin induces genotoxicity.
Ribavirin has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect. Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy. The haemolytic anaemia associated with ribavirin therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease. An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients.
The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa-2b or peginterferon alfa-2b.
Please refer to the corresponding SmPC of medicinal products that are used in combination with ribavirin for additional undesirable effects reported with these products.
The safety of ribavirin capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin in combination with interferon alfa-2b, two trials studied ribavirin in combination with peginterferon alfa-2b.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
The adverse reactions listed below are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use. A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference. Also, refer to peginterferon alfa-2b and interferon alfa-2b SmPCs for adverse reactions that may be attributable to interferons monotherapy. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b:
Very common: Viral infection, pharyngitis
Common: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Uncommon: Lower respiratory tract infection
Rare: Pneumonia*
Common: Neoplasm unspecified
Very common: Anaemia, neutropenia
Common: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia
Very rare: Aplastic anaemia*
Not known: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Uncommon: Drug hypersensitivity
Rare: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Not known: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Common: Hypothyroidism, hyperthyroidism
Very common: Anorexia
Common: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Uncommon: Diabetes mellitus, hypertriglyceridemia*
Very common: Depression, anxiety, emotional lability, insomnia
Common: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour, nervousness, sleep disorder, decreased libido apathy, abnormal dreams, crying
Uncommon: Suicide attempts, panic attack, hallucination
Rare: Bipolar disorder*
Very rare: Suicide*
Not known: Homicidal ideation*, mania*, mental status change
Very common: Headache, dizziness, dry mouth, concentration impaired
Common: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Uncommon: Neuropathy, peripheral neuropathy
Rare: Seizure (convulsion)*
Very rare: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Not known: Facial palsy, mononeuropathies
Common: Visual disturbance, blurred vision, conjunctivitis, eye irritation, eye pain, abnormal vision, lacrimal gland disorder, dry eye
Rare: Retinal haemorrhages*, retinopathies (including macular oedema), retinal artery occlusion, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates
Common: Vertigo, hearing impaired/loss, tinnitus, ear pain
Common: Palpitation, tachycardia
Uncommon: Myocardial infarction
Rare: Cardiomyopathy, arrhythmia*
Very rare: Cardiac ischaemia*
Not known: Pericardial effusion*, pericarditis*
Common: Hypotension, hypertension, flushing
Rare: Vasculitis
Very rare: Peripheral ischaemia*
Very common: Dyspnoea, coughing
Common: Epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain, nonproductive cough
Very rare: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Very common: Diarrhoea, vomiting, nausea, abdominal pain
Common: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophoageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence
Uncommon: Pancreatitis, oral pain
Rare: Ischaemic colitis
Very rare: Ulcerative colitis*
Not known: Periodontal disorder, dental disorder, tongue pigmentation
Common: Hepatomegaly, jaundice, hyperbilirubinemia*
Very rare: Hepatotoxicity (including fatalities)*
Very common: Alopecia, pruritus, skin dry, rash
Common: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Rare: Cutaneous sarcoidosis
Very rare: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Very common: Arthralgia, myalgia, musculoskeletal pain
Common: Arthritis, back pain, muscle spasms, pain in extremity
Uncommon: Bone pain, muscle weakness
Rare: Rhabdomyolysis*, myositis*
Common: Micturition frequency, polyuria, urine abnormality
Rare: Renal failure, renal insufficiency*
Very rare: Nephrotic syndrome*
Common: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder. Male: impotence, prostatitis, erectile dysfunction. Sexual dysfunction (not specified)*
Very common: Fatigue, rigors, pyrexia, influenza like illness, asthenia, irritability
Common: Chest pain, chest discomfort, peripheral oedema, malaise, feeling abnormal, thirst
Uncommon: Face oedema
Very common: Weight decrease
Common: Cardiac murmur
* Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or non-pegylated).
A reduction in haemoglobin concentrations by >4 g/dL was observed in 30% of patients treated with ribavirin and peginterferon alfa-2b and 37% of patients treated with ribavirin and interferon alfa-2b. Haemoglobin levels dropped below 10 g/dL in up to 14% of adult patients and 7% of children and adolescents treated with ribavirin in combination with either peginterferon alfa-2b or interferon alfa-2b.
Most cases of anaemia, neutropenia, and thrombocytopenia were mild (WHO grades 1 or 2). There were some cases of more severe neutropenia in patients treated with ribavirin in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21%]; and WHO grade 4: 13 of 186 [7%]); WHO grade 3 leukopenia was also reported in 7% of this treatment group.
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy. Among those patients with elevated uric acid levels, very few patients treated with the combination developed clinical gout, none of which required treatment modification or discontinuation from the clinical trials.
For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency >5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment. Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa-2b when compared to patients receiving ribavirin in combination with interferon alfa-2b. In Study 1, decrease in absolute neutrophil count levels below 500 cells/mm³ was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm³ was observed in 4% (8/194) of patients receiving ribavirin in combination with peginterferon alfa-2b. Anaemia (haemoglobin <9.4 g/dL) was reported in 12% (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Treatment with ribavirin in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage. The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy. The use of ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up. Limited safety data (N=25) are available in co-infected patients with CD4+ cell counts <200/µL.
Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin in combination with other medicinal products.
In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of peginterferon alfa-2b and ribavirin, dose modifications were required in 25% of patients, most commonly for anaemia, neutropenia and weight loss. In general, the adverse reactions profile in children and adolescents was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition. During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients. Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and in height percentiles were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (<3rd percentile in 70% of the patients).
At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still 3 percentiles and 7 percentiles, respectively, and 20% of the children continued to have inhibited growth (growth velocity <3rd percentile). Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial. The effects on growth were less in those children treated for 24 weeks than those treated for 48 weeks. From pre-treatment to end of long-term follow-up among children treated for 24 or 48 weeks, height-for-age percentiles decreased 1.3 and 9.0 percentiles, respectively. Twenty-four percent of children (11/46) treated for 24 weeks and 40% of children (19/48) treated for 48 weeks had a >15 percentile height-for-age decrease from pre-treatment to the end of 5 year long-term follow-up compared to pre-treatment baseline percentiles. Eleven percent of children (5/46) treated for 24 weeks and 13% of children (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline >30 height-for-age percentiles to the end of the 5 year long-term follow-up. For weight, pre-treatment to end of long-term follow-up, weight-for-age percentiles decreased 1.3 and 5.5 percentiles among children treated for 24 weeks or 48 weeks, respectively. For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among children treated for 24 weeks or 48 weeks, respectively. Decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children. The decline of height, weight and BMI Z scores observed during the treatment phase in comparison to a normative population did not fully recover at the end of long-term follow-up period for children treated with 48 weeks of therapy.
In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80%), headache (62%), neutropenia (33%), fatigue (30%), anorexia (29%) and injection-site erythema (29%). Only 1 subject discontinued therapy as the result of an adverse reaction (thrombocytopenia). The majority of adverse reactions reported in the study were mild or moderate in severity. Severe adverse reactions were reported in 7% (8/107) of all subjects and included injection site pain (1%), pain in extremity (1%), headache (1%), neutropenia (1%), and pyrexia (4%). Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8%), aggression (3%), anger (2%), depression/depressed mood (4%) and hypothyroidism (3%) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6% discontinued therapy due to adverse reactions. In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment. Within the 5 years follow-up post-treatment period, the children had a mean height of 44th percentile, which was below the median of the normative population and less than their mean baseline height (48th percentile). Twenty (21%) of 97 children had a >15 percentile decrease in height percentile, of whom 10 of the 20 children had a >30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years). Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits >15 percentiles, 10 to 12 years after the end of treatment. During combination therapy for up to 48 weeks with interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients. In particular, decrease in mean height percentile from baseline to the end of the long-term follow-up was most prominent in prepubertal age children.
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs. 1%) during treatment and during the 6 month follow-up after treatment. As in adult patients, children and adolescents also experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence). In addition, injection site disorders, pyrexia, anorexia, vomiting and emotional lability occurred more frequently in children and adolescents compared to adult patients. Dose modifications were required in 30% of patients, most commonly for anaemia and neutropenia.
Reported adverse reactions listed below are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions very commonly, commonly and uncommonly reported during clinical trials in children and adolescents with ribavirin in combination with interferon alfa-2b or peginterferon alfa-2b:
Very common: Viral infection, pharyngitis
Common: Fungal infection, bacterial infection, pulmonary infection, nasopharyngitis, pharyngitis streptococcal, otitis media, sinusitis, tooth abscess, influenza, oral herpes, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Uncommon: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps)
Common: Neoplasm unspecified
Very common: Anaemia, neutropenia
Common:__ Thrombocytopenia, lymphadenopathy
Very common: Hypothyroidism
Common: Hyperthyroidism, virilism
Very common: Anorexia, increased appetite, decreased appetite
Common: Hypertriglyceridemia, hyperuricemia
Very common: Depression, insomnia, emotional lability
Common: Suicidal ideation, aggression, confusion, affect liability, behaviour disorder, agitation, somnambulism, anxiety, mood altered, restlessness, nervousness, sleep disorder, abnormal dreaming, apathy
Uncommon: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Very common: Headache, dizziness
Common: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Uncommon: Neuralgia, lethargy, psychomotor hyperactivity
Common: Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Uncommon: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia
Common: Vertigo
Common: Tachycardia, palpitations
Common: Pallor, flushing
Uncommon: Hypotension
Common: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal pain
Uncommon: Wheezing, nasal discomfort
Very common: Abdominal pain, abdominal pain upper, vomiting , diarrhoea, nausea
Common: Mouth ulceration, stomatitis ulcerative, stomatitis, aphthous stomatitis, dyspepsia, cheilosis, glossitis, gastroesophoageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder, stomach discomfort, oral pain
Uncommon: Gingivitis
Common: Hepatic function abnormal
Uncommon: Hepatomegaly
Very common: Alopecia, rash
Common: Pruritus, photosensitivity reaction, maculopapular rash, eczema, hyperhidrosis, acne, skin disorder, nail disorder, skin discolouration, dry skin, erythema, bruise
Uncommon: Pigmentation disorder, dermatitis atopic, skin exfoliation
Very common: Arthralgia, myalgia, musculoskeletal pain
Common: Pain in extremity, back pain, muscle contracture
Common: Enuresis, micturition disorder, urinary incontinence, proteinuria
Common: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Uncommon: Female: dysmenorrhoea
Very common: Fatigue, rigors, pyrexia, influenza-like illness, asthenia, malaise, irritability
Common: Chest pain, oedema, pain, feeling cold
Uncommon: Chest discomfort, facial pain
Very common: Growth rate decrease (height and/or weight decrease for age)
Common: Blood thyroid stimulating hormone increased, thyroglobulin increased
Uncommon: Anti-thyroid antibody positive
Common: Skin laceration
Uncommon: Contusion
Most of the changes in laboratory values in the ribavirin/peginterferon alfa-2b clinical trial were mild or moderate. Decreases in haemoglobin, white blood cells, platelets, neutrophils and increase in bilirubin may require dose reduction or permanent discontinuation from therapy. While changes in laboratory values were observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
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