Formulary
Ribavirin: Indications, Dosing, Side Effects and Interactions
Ribavirin clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Ribavirin: Indications, Dosing, Side Effects and Interactions
Ribavirin clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Chronic hepatitis C (in combination with direct acting antivirals, or interferon alfa 2a, or peginterferon alfa 2a with or without direct acting antivirals)**
- **Adult** (By Mouth): (body-weight 75 kg and above) 600 mg twice daily.
**Chronic hepatitis C (in combination with peginterferon alfa 2b with or without direct acting antivirals)**
- **Adult** (By Mouth): (body-weight 106 kg and above) 600 mg, to be taken in the morning and 800 mg, to be taken in the evening.
**Chronic hepatitis C genotype 2 or 3 (not previously treated), or patients infected with HIV and hepatitis C (in combination with peginterferon alfa)**
- **Adult** (By Mouth): Usual dose 400 mg twice daily.
**Chronic hepatitis C (in combination with interferon alfa 2b, or peginterferon alfa 2b with or without boceprevir)**
- **Adult** (By Mouth): (body-weight 105 kg and above) 600 mg, dose to be taken in the morning and 800 mg, dose to be taken in the evening.
**Bronchiolitis for ribavirin**
- **Child 1-23 months** (By inhalation of aerosol, or by inhalation of nebulised solution): Inhale a solution containing 20 mg/mL for 12-18 hours for at least 3 days, maximum of 7 days, to be administered via small particle aerosol generator.
**Life-threatening RSV, parainfluenza virus, and adenovirus infection in immunocompromised children (administered on expert advice) for ribavirin**
- **Child** (By intravenous infusion): 33 mg/kg for 1 dose, to be administered over 15 minutes, then 16 mg/kg every 6 hours for 4 days, then 8 mg/kg every 8 hours for 3 days.
**Chronic hepatitis C (in combination with interferon alfa or peginterferon alfa) in previously untreated children without liver decompensation for Rebetol capsules**
- **Child 3-17 years (body-weight up to 47 kg)** (By mouth): 15 mg/kg daily in 2 divided doses.
- **Child 3-17 years (body-weight 47-49 kg)** (By mouth): 200 mg, dose to be given in the morning and 400 mg, dose to be given in the evening.
- **Child 3-17 years (body-weight 50-64 kg)** (By mouth): 400 mg twice daily.
- **Child 3-17 years (body-weight 65-80 kg)** (By mouth): 400 mg, dose to be given in the morning and 600 mg, dose to be given in the evening.
- **Child 3-17 years (body-weight 81-104 kg)** (By mouth): 600 mg twice daily.
- **Child 3-17 years (body-weight 105 kg and above)** (By mouth): 600 mg, dose to be given in the morning and 800 mg, dose to be given in the evening.
Cautions
When used by inhalation Maintain standard supportive respiratory and fluid management therapy With systemic use Anaemia (haemoglobin concentration should be monitored during the treatment and corrective action taken); cardiac disease (assessment including ECG recommended before and during treatment-discontinue if deterioration); consult product literature for specific cautions when ribavirin used in combination with other medicinal products; gout; haemolysis (haemoglobin concentration should be monitored during the treatment and corrective action taken); patients with a transplant-risk of rejection; severe dental disorders; severe ocular disorders; severe periodontal disorders; severe psychiatric effects
Contraindications
With systemic use Consult product literature for specific contra-indications when ribavirin used in combination with other medicinal products; haemoglobinopathies; severe cardiac disease; unstable or uncontrolled cardiac disease in previous 6 months
Side effects
Common or very common Alopecia; anaemia; anxiety; appetite decreased; arrhythmias; arthralgia; arthritis; asthenia; behaviour abnormal; chest pain; chills; concentration impaired; constipation; cough; depression; diarrhoea; dizziness; drowsiness; dry mouth; dysphagia; dyspnoea; ear pain; eye disorders; eye inflammation; eye pain; fever; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; headaches; hyperthyroidism; hypotension; hypothyroidism; increased risk of infection; influenza like illness; lymphadenopathy; malaise; memory loss; mood altered; muscle complaints; muscle weakness; nasal congestion; nausea; neutropenia; oral disorders; pain; palpitations; peripheral oedema; photosensitivity reaction; respiratory disorders; sensation abnormal; sexual dysfunction; skin reactions; sleep disorders; sweat changes; syncope; taste altered; thirst; throat pain; thrombocytopenia; tinnitus; tremor; vasodilation; vertigo; vision disorders; vomiting; weight decreased Uncommon Dehydration; diabetes mellitus; hallucination; hearing loss; hepatic disorders; hypertension; nerve disorders; sarcoidosis; suicidal behaviours; thyroiditis Rare or very rare Angina pectoris; angioedema; bone marrow disorders; cardiac inflammation; cerebral ischaemia; cholangitis; coma; congestive heart failure; facial paralysis; hepatic failure (discontinue); hypersensitivity; interstitial pneumonitis; intracranial haemorrhage; myocardial infarction; myopathy; pancreatitis; psychotic disorder; pulmonary embolism; retinopathy; seizure; severe cutaneous adverse reactions (SCARs); systemic lupus erythematosus (SLE); vasculitis Frequency not known Haemolytic anaemia; homicidal ideation; nephrotic syndrome; pure red cell aplasia; renal failure; solid organ transplant rejection; tongue discolouration; ulcerative colitis Side-effects, further information Side effects listed are reported when oral ribavirin is used in combination with peginterferon alfa or interferon alfa, consult product literature for details.
Interactions
**Severe interactions:**
- Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
**Other interactions (23):**
- Interaction studies have been conducted with ribavirin in combination with peginterferon alfa-2a, interferon alfa-2b and antacids.
- Ribavirin concentrations are similar when given alone or concomitantly with interferon alfa-2b or peginterferon alfa-2a.
- Any potential for interactions may persist for up to 2 months (5 half lives for ribavirin) after cessation of ribavirin therapy due to the long half-life.
- Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
- Ribavirin does not inhibit cytochrome P450 enzymes.
- There is no evidence from toxicity studies that ribavirin induces liver enzymes.
Pregnancy
Avoid; teratogenicity in animal studies. When used by inhalation: Pregnant women should avoid exposure to aerosol.
Breast feeding
Avoid-no information available.
Renal impairment
Plasma-ribavirin concentration increased. Manufacturer advises avoid oral ribavirin unless essential if eGFR less than 50 mL/minute/1.73 m 2 -monitor haemoglobin concentration closely.
Medicinal forms
Tablet,Capsule
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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