What the label lists and what reports show
Ribavirin side effects
Ribavirin's FDA label: “The most common serious or life-threatening adverse reactions induced or aggravated by ribavirin/PEGASYS ® include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%.” FAERS holds 63,917 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (9,561 reports).
- Generic listed
- Boxed warning
Check it at the source: the ribavirin FDA label on DailyMed (effective February 6, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ribavirin tablets?Ribavirin tablets may cause serious side effects including: See “What is the most important information I should know about ribavirin tablets?” Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting or diarrhea. Severe allergic reactions. Symptoms may include hives, wheezing, trouble breathing, chest pain, swelling of your mouth, tongue, or lips, or severe rash. Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death. Serious eye problems that may lead to vision loss or blindness. Liver problems. Some people may get worsening of liver function. Tell your healthcare provider right away if you have any of these symptoms: stomach bloating, confusion, brown urine, and yellow eyes. Severe depression Suicidal thoughts and attempts Effect on growth in children. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective February 6, 2024 (SPL set eee304d0-c2ea-44f4-97d9-92a414d31b6c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common serious or life-threatening adverse reactions induced or aggravated by ribavirin/PEGASYS ® include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%.
Table 6 Percentage of Pediatric Subjects with Adverse Reactions* During First 24 Weeks of Treatment by Treatment Group and for 24 Weeks Post-treatment (in at Least 10% of Subjects)
| System Organ Class | PEGASYS ® 180 mcg/1.73 m² x BSA + Ribavirin 15 mg/kg (N=55) % | PEGASYS ® 180 mcg/1.73 m² x BSA + Placebo** (N=59) % |
|---|---|---|
| Influenza like illness | 91 | 81 |
| Injection site reaction | 44 | 42 |
| Fatigue | 25 | 20 |
| Irritability | 24 | 14 |
| Gastrointestinal disorder | 49 | 44 |
| Headache | 51 | 39 |
| Rash | 15 | 10 |
| Pruritus | 11 | 12 |
| Musculoskeletal pain | 35 | 29 |
| Insomnia | 9 | 12 |
| Decreased appetite | 11 | 14 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedPEGASYS ® in combination with ribavirin causes a broad variety of serious adverse reactions [see Boxed Warning and Warnings and Precautions (5) ]. The most common serious or life-threatening adverse reactions induced or aggravated by ribavirin/PEGASYS ® include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) CHC/HIV patients [see Warnings and Precautions (5.3) ]. The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1) The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adult Patients In the pivotal registration trials NV15801 and NV15942, 886 patients received ribavirin for 48 weeks at doses of 1000/1200 mg based on body weight. …
Source: FDA drug label, 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?
63,917 reports list ribavirin among the medicines taken, 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. Of the 23 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ribavirin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions