Rebetol, illustration of capsule form (not a photo of the actual pack)

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Rebetol

Ribavirin

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$745.00

200mg · 1 capsules

BrandBranded medicine· By Merck

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FDA boxed warningEmbryo-fetal toxicity, hemolytic anemia, and monotherapy not recommended

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.

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.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.

ANEMIA, and MONOTHERAPY NOT RECOMMENDED

Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy 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.

The hemolytic 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.

Read this with the rest of the clinical information

About Rebetol

Overview

Rebetol contains ribavirin, an antiviral medicine that acts against the hepatitis C virus. It is used with interferon alfa-2b, either pegylated or nonpegylated, to treat chronic hepatitis C in patients aged 3 years and older. It is for patients with compensated liver disease, meaning the liver can still carry out its main functions.

What it treats

Chronic hepatitis C in patients aged 3 years and older with compensated liver disease, used in combination with pegylated or nonpegylated interferon alfa-2b.

Safety information

Side effects

Common side effects reported in adults taking ribavirin with PegIntron or INTRON A include injection-site reactions, tiredness or weakness, headache, shaking chills, fever, nausea, muscle pain, anxiety, mood swings and irritability. In children taking ribavirin with PegIntron, common effects include fever, headache, low neutrophil counts (a type of white blood cell), tiredness, reduced appetite, injection-site redness and vomiting. Contact your doctor if you develop serious side effects, including anemia caused by the breakdown of red blood cells, inflammation of the pancreas, lung problems, new or worsening eye problems, severe decreases in white blood cells or platelets, thyroid or liver abnormalities, or dental and gum problems. Anemia caused by red blood cell breakdown occurred in more than 10% of adults receiving combination treatment. Children may experience weight loss and slowed growth; long-term effects on height have been reported in some patients. Ribavirin can harm an unborn baby. A negative pregnancy test is required before treatment, with effective contraception and periodic pregnancy tests during treatment. Contact your doctor immediately if pregnancy occurs or is suspected.

FDA boxed warning

Embryo-fetal toxicity, hemolytic anemia, and monotherapy not recommended

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.

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.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.

ANEMIA, and MONOTHERAPY NOT RECOMMENDED

Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy 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.

The hemolytic 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.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek immediate medical attention for new or worsening breathing problems. - Seek immediate medical attention for new or worsening vision problems. - Contact your doctor immediately if you become pregnant during treatment or within 9 months after treatment ends. - If you are a male patient, contact your doctor immediately if your partner becomes pregnant during your treatment or within 6 months after treatment ends.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take Rebetol (ribavirin) if you are pregnant or planning to become pregnant, or if your female partner is pregnant. Ribavirin may harm an unborn baby. The label requires a negative pregnancy test before treatment, effective contraception and periodic pregnancy testing. Do not take it if you have an allergy to ribavirin or any capsule ingredient, including a history of severe skin reactions to them; autoimmune hepatitis; a haemoglobin disorder such as thalassaemia major or sickle-cell anaemia; or reduced kidney function with a creatinine clearance below 50 mL/min. Do not take ribavirin with didanosine. This combination has been associated with fatal liver failure, nerve damage, pancreatitis and a dangerous build-up of lactic acid. Ribavirin must not be used on its own. Close monitoring is needed for anaemia caused by red blood cell breakdown, pancreatitis, lung problems, new or worsening eye disorders, severe falls in white blood cell or platelet counts, and other blood, thyroid or liver abnormalities. These problems may require the prescriber to adjust or stop treatment. Taking azathioprine alongside ribavirin also requires close monitoring. Combination treatment has been associated with dental and gum problems, and with weight loss and slowed growth in children. Long-term effects on height have been reported in some children. Safety and effectiveness have not been established in children under 3 years or in people who also have HIV or hepatitis B, and have not been studied in organ transplant recipients.

Interactions

Tell your doctor if you take nucleoside analogues, including nucleoside reverse transcriptase inhibitors. These medicines require close monitoring for toxic effects when used with ribavirin. If toxicity worsens, your doctor may need to adjust or stop ribavirin, interferon or the nucleoside reverse transcriptase inhibitor.

Using Rebetol

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED] (DailyMed, retrieved 19 September 2026).

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