Ribavirin Side Effects: Adverse Events That Are Not Serious?
The following are some of the most common adverse events (AEs) reported with ribavirin. These include AEs that have been associated with ribavirin use in clinical trials and from other studies. There may be others that have not yet been identified or reported. Some of these AEs are serious and require medical attention. Other AEs are considered minor and do not need any special treatment.
Above: The most common adverse events reported with ribavirin include fatigue, insomnia, headache, and anemia. This list is not all-inclusive and other less common adverse events have also been reported.
Fatigue, insomnia, headache, and anemia are some of the most common adverse events reported with ribavirin. Some patients have more than one adverse event.
Fatigue is the most common adverse event reported in clinical studies, occurring in more than half of all patients. It has been reported to be severe in 15 percent of patients. Fatigue is more common in adults than in children and generally becomes less troublesome over time. In some cases, ribavirin treatment is discontinued because of fatigue.
In most studies, about a third of patients experience insomnia. In some cases, treatment with ribavirin is stopped because of insomnia.
Headache and anemia are also common adverse events. Anemia has been reported in more than half of all patients. Anemia has been reported to be severe in some cases, but does not seem to require discontinuation of ribavirin in most patients.
Other adverse events that have been reported in several studies, but are less common, include nausea, vomiting, diarrhea, abdominal pain, loss of appetite, and irritability.
Other less common adverse events that have been reported include central and peripheral neurological disorders, such as paresthesia and peripheral neuropathy, depression, emotional liability, sleep disorder, renal failure, hematuria, hirsutism, and decreased libido. There is limited information available on these adverse events.
In studies, fewer than 10 percent of the patients have experienced psychiatric disturbances, including depression, anxiety, irritability, anger, confusion, and impaired judgment.
More serious adverse events have been reported rarely. Reports of death have occurred, but it is not known whether they were caused by the treatment. Other serious adverse events reported during clinical studies include cardiac arrest, TEN, hepatitis, pancytopenia, SJS, skin cancer, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Contraindications for Ribavirin
Most contraindications for ribavirin are based on the drug’s side effects.
Most contraindications for ribavirin are based on the drug’s side effects or adverse events. For instance, the drug should not be used by people with pre-existing cardiac disease because of the risk of developing cardiomyopathy. The same goes for people with pre-existing renal dysfunction or hepatic dysfunction.
Contraindications for ribavirin also include women who are pregnant or nursing, since the drug is excreted in the milk and can cause harm to the baby.
Special Concerns for Ribavirin
As far as special conditions or requirements, ribavirin is best absorbed by people who have a normal diet. It is recommended that patients eat a diet rich in carbohydrates and take their ribavirin pills either with or immediately after a meal.
The FDA has approved ribavirin to treat hepatitis C in people with compensated liver cirrhosis (compensated means that although there is some damage to the liver, it’s functioning overall isn’t significantly impaired).
The safety and effectiveness of ribavirin has not been established in people with advanced cirrhosis (decompensation) or in pediatric patients.
The safety and effectiveness of combining ribavirin with interferon has not been established in pediatric patients or in women who are pregnant or nursing.
Ribavirin can be taken with or without food, but it is best absorbed with food.
Ribavirin and Pregnancy
The U.S. Food and Drug Administration (FDA) has given ribavirin Pregnancy Category C classification, which means that the risks associated with the drug may be greater than the potential benefits for the unborn baby.
This drug is known to be excreted in human milk. The benefits of taking ribavirin should be weighed against the potential risks when used during pregnancy or when breastfeeding.
Ribavirin and HIV
The FDA has also given ribavirin an interaction rating of major drug-drug interaction (avoid taking it with other drugs or changing the schedule of your medication).
This rating is due to the fact that ribavirin can cause serious side effects and patients should be monitored by a doctor while they are taking it.
Ribavirin and Alcohol
Ribavirin can cause CNS depression, and although no serious reactions have been reported when taking the drug with alcohol, it is not recommended.
Other adverse reactions that may occur are fatigue, insomnia, nausea, and headache. The medication may also increase the severity of fever and hyperglycemia (high blood sugar).
Ribavirin is not recommended for women who are pregnant or nursing. It may cause harm to the baby and is secreted in human milk.
The drug should be used with caution in people with pre-existing psychiatric conditions, diabetes or epilepsy, as these conditions may become worse while the patient is using the medication.
The medication may worsen the patient’s health status. People who are immunosuppressed or have a history of severe hemophilia should avoid taking ribavirin.
If you have a history of cardiac disease, you should be monitored by a physician while you are taking this medication.
Ribavirin should not be used with AZT or Arbidol (dideoxycytidine).
This drug may cause birth defects and should not be used by pregnant women. If you are a female of childbearing potential and think you may be pregnant, you should tell your physician before starting ribavirin therapy.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Sources & references used in this article:
- Adverse effects of ribavirin and outcome in severe acute respiratory syndrome: experience in two medical centers (HE Chiou, CL Liu, MJ Buttrey, HP Kuo, HW Liu, HT Kuo… – Chest, 2005 – Elsevier)
- Management of adverse effects of Peg-IFN and ribavirin therapy for hepatitis C (MS Sulkowski, C Cooper, B Hunyady, J Jia… – Nature reviews …, 2011 – nature.com)
- Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C: meta-analysis of individual patient data from European centers (SW Schalm, BE Hansen, L Chemello, A Bellobuono… – Journal of …, 1997 – Elsevier)
- Premature discontinuation of interferon plus ribavirin for adverse effects: a multicentre survey in ‘real world’patients with chronic hepatitis C (GB Gaeta, DF Precone, FM Felaco… – Alimentary …, 2002 – Wiley Online Library)