Prescription medicine
Ribavirin First approved as Virazole
Ribavirin (Virazole) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $0.451 per ribavirin 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ribavirin FDA label on DailyMed (effective February 6, 2024, Aurobindo Pharma Limited); the NDA 18859 record on Drugs@FDA; every ribavirin label on DailyMed.
Highlights of the record
FDA label of February 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication. The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin [see Warnings and Precautions (5.2), Adverse Reactions (6.1), and Dosage and Administration (2.3) ]. Significant teratogenic and/or 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 it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin, including ribavirin tablets, are contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. […]
Used for
From the label: indications and usageRibavirin tablets in combination with PEGASYS ® (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Forms and strengths
- 6 g
- 200 mg
Film-coated tablet; powder for solution; capsule.
On the market
- Earliest approval on file
- December 31, 1985 Virazole, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first April 6, 2004; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.451 per tablet Ribavirin 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 63,917 through July 30, 2026
What is ribavirin used for?
From the label: indications and usageRibavirin tablets in combination with PEGASYS ® (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with PEGASYS ® : This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3 . […]
Conditions named in the indications of ribavirin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Analog Antiviral.
Source: FDA drug label (Ribavirin), Aurobindo Pharma Limited, effective February 6, 2024 (SPL set eee304d0-c2ea-44f4-97d9-92a414d31b6c), via openFDA; the full label on DailyMed
What does the patient leaflet for ribavirin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ribavirin tablets?You should not take ribavirin tablets alone to treat chronic hepatitis C infection. Ribavirin tablets should be used with PEGASYS ® to treat chronic hepatitis C infection. 2. Ribavirin tablets may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. Tell your healthcare provider if you have ever had any heart problems. Ribavirin tablets may not be right for you. If you have chest pain while you take ribavirin tablets, get emergency medical attention right away. 3. Ribavirin tablets may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, do not take ribavirin tablets. You or your sexual partner should not become pregnant while you take ribavirin tablets and for 6 months after treatment is over. You must use two forms of birth control when you take ribavirin tablets and for the 6 months after treatment. Females must have a pregnancy test before starting ribavirin tablets, every month while treated with ribavirin tablets, and every month for the 6 months after treatment with ribavirin tablets. If you or your female sexual partner becomes pregnant while taking ribavirin tablets or within 6 months after you stop taking ribavirin tablets, tell your healthcare provider right away.
From the patient leaflet: What should I avoid while taking ribavirin tablets?Ribavirin tablets can make you feel tired, dizzy, or confused. You should not drive or operate machinery if you have any of these symptoms. Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse.
From the patient leaflet: How should I store ribavirin tablets?Store ribavirin tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Keep ribavirin tablets and all medicines out of the reach of children.
Source: FDA drug label (Ribavirin), Aurobindo Pharma Limited, effective February 6, 2024 (SPL set eee304d0-c2ea-44f4-97d9-92a414d31b6c), via openFDA; the full label on DailyMed
Is there a generic for ribavirin (Virazole)?
The FDA approved the first generic ribavirin on April 6, 2004. 12 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ribavirin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1985 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ribavirin (Virazole)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.451 per Ribavirin 200 mg tablet. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ribavirin 200 mg tablet | Generic | $0.451 per tablet | $13.52 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ribavirin been recalled?
The FDA's Enforcement Report lists 1 recall naming ribavirin since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of ribavirin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ribavirin label say about other medicines?
The ribavirin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name ribavirin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abacavir | warnings and precautions | All 14 patients were on NRTIs, including stavudine, didanosine, abacavir, zidovudine, and lamivudine. |
| Azathioprine | drug interactions | Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities (7.1) Azathioprine: |
| Digoxin | drug interactions | Drug Interactions Clinical studies of interactions of Ribavirin for Inhalation Solution, USP with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. |
| Lamivudine | drug interactions | Inhibitors (NRTIs) In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. |
| Peginterferon alfa 2a | contraindications | Ribavirin tablets and PEGASYS ® combination therapy are contraindicated in patients with: Autoimmune hepatitis. |
| Zidovudine | drug interactions | Inhibitors (NRTIs) In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. |
Other labels that name ribavirin
Source: FDA drug label (Ribavirin), Aurobindo Pharma Limited, effective February 6, 2024 (SPL set eee304d0-c2ea-44f4-97d9-92a414d31b6c), via openFDA; the full label on DailyMed
What do FAERS reports show for ribavirin?
The FDA Adverse Event Reporting System holds 63,917 reports that list ribavirin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,412 are coded as a death and 14,145 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (5,553, against a median of 505 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ribavirin?
6 other medicines are given the same way (oral) and in the same FDA class as ribavirin or labeled mainly for the same use (hepatitis c), the same class first. Hepatitis C lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ledipasvir and sofosbuvir | Hepatitis C | none listed | n/a | No current entry |
| Sofosbuvir and velpatasvir | Hepatitis C | none listed | $278.03 per unit 400-100 | No current entry |
| Sofosbuvir | Hepatitis C | none listed | n/a | No current entry |
| Glecaprevir and pibrentasvir | Hepatitis C | none listed | $152.98 per tablet 100-40 mg tablet | No current entry |
| Elbasvir and grazoprevir | Hepatitis C | none listed | n/a | A presentation being discontinued |
| Sofosbuvir and velpatasvir and voxilaprevir | Hepatitis C | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ribavirin
- 6 medicines for the same use
- Other nucleoside analog antivirals
- the pharmacologic class, with prices and generics
- Ribavirin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other