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Ribavirin

Viranis, Viron · ATC code J05AB04

Key facts
Active substance
Ribavirin
Drug class
Direct acting antiviral
ATC code
J05AB04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

  • Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days and may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy and use effective contraception during therapy and for 9 months after completion of treatment in female patients and for 6 months in female partners of male patients who are taking ribavirin therapy. [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3), and Nonclinical Toxicology (13.1)].
  • Hemolytic anemia has been reported with ribavirin therapy. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin [see Dosage and Administration (2.5), Warnings and Precautions (5.2), and Adverse Reactions (6.1)].
  • Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication [see Warnings and Precautions (5.10)].

Key facts

Ribavirin is, per the US prescribing information, an antiviral used in combination with interferon alfa-2b (pegylated or nonpegylated) to treat chronic hepatitis C in patients 3 years and older.

What it is used for

  • Chronic hepatitis C with compensated liver disease in patients 3 years of age and older, in combination with PegIntron or INTRON A.
  • The combination with PegIntron is preferred, as it gives substantially better response rates.
  • Ineffective as monotherapy and must not be used alone.

Dosing

  • Take capsules with food; do not open, crush or break them.
  • Adults with PegIntron: 800 mg to 1,400 mg daily based on body weight, in two divided doses (weight table in the full text).
  • Duration for genotype 1: 48 weeks; for genotype 2 and 3: 24 weeks; consider stopping if response is inadequate at 12 or 24 weeks.
  • Children 3 to 17 years: 15 mg/kg/day in two divided doses.
  • Modify or stop the dose for severe adverse reactions or laboratory abnormalities; contraindicated at creatinine clearance less than 50 mL/min.

Contraindications

  • Pregnancy, and men whose female partners are pregnant.
  • Severe hypersensitivity reactions to ribavirin (e.g. Stevens-Johnson syndrome).
  • Autoimmune hepatitis; hemoglobinopathies (e.g. thalassemia major, sickle-cell anemia).
  • Creatinine clearance less than 50 mL/min; coadministration with didanosine.

Important warnings

  • Boxed warning: significant teratogenic and embryocidal effects; multiple-dose half-life of 12 days, may persist for as long as 6 months; effective contraception during and for 9 months after treatment in female patients, and for 6 months in female partners of male patients.
  • Boxed warning: hemolytic anemia (about 10%), which may worsen cardiac disease and lead to myocardial infarction; not for patients with significant or unstable cardiac disease.
  • Pancreatitis, pulmonary disorders (including fatal pneumonia), dental and periodontal disorders.
  • Severe decreases in neutrophil and platelet counts; check hematology and blood chemistry before and during therapy.
  • Growth inhibition in children; severe depression and suicidal ideation with combination therapy.

Side effects

  • Primary toxicity: hemolytic anemia, usually within the first 1 to 2 weeks.
  • Most common in adults (with combination therapy): injection site reactions, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, anxiety/irritability.
  • In children: pyrexia, headache, neutropenia, fatigue, anorexia, vomiting.

Interactions

  • Didanosine: increased exposure with fatal hepatic failure, neuropathy, pancreatitis and lactic acidosis; contraindicated.
  • Nucleoside reverse transcriptase inhibitors: hepatic decompensation possible in HIV/HCV co-infection; monitor closely.
  • Azathioprine: pancytopenia and bone marrow suppression have been reported.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; pregnancy test before starting, periodically during treatment and during the 9 months afterwards.
  • There are no data on presence in human milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • Ribavirin RatiopharmRatiopharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • ViranisALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
  • VironSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 6 more European countries
Cyprus
Ribavirin Aurobindo
France
Ribavirine Pharmadev, Ribavirine Skyepharma, Ribavirine Viatris
Italy
Ribavirina Aurobindo
Netherlands
Ribavirine Ratiopharm
Portugal
Ribavirina Aurobindo
Spain
Ribavirina Normon

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Ribavirin (Aurobindo Pharma Limited) – Prescribing Information, 2024-02-06. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35f99f76-f2ef-4a81-91ff-285419664be3
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC J05AB.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.