Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ribavirin
Drug ID BADD_D01933
Description Producing a broad-spectrum activity against several RNA and DNA viruses, Ribavirin is a synthetic guanosine nucleoside and antiviral agent that interferes with the synthesis of viral mRNA. It is primarily indicated for use in treating hepatitis C and viral hemorrhagic fevers. HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients [L852]. It is reported that ribavirin might be only effective in early stages of viral hemorrhagic fevers including Lasser fever, Crimean-Congo hemorrhagic fever, Venezuelan hemorrhagic fever, and Hantavirus infection. Ribavirin is a prodrug that is metabolized into nucleoside analogs that blocks viral RNA synthesis and viral mRNA capping. Before the development of newer drugs, ribavirin and [DB00008]/[DB00022] dual therapy was considered the first-generation and standard antiviral treatment [A19626]. The dual therapy was administered for 48 weeks in patients with genotype 1, 4, 5, and 6, and 24 weeks in patients with genotype 2 and 3 [A19626]. Newer drugs developed as Hepatitis C viral infection treatments can be used to reduce or eliminate the use of ribavirin, which are associated with serious adverse effects. They also improve therapeutic efficacy in patients with failed [DB00008]/[DB00022] and ribavirin-based therapy. The potential use of ribavirin as a treatment for acute myeloid leukemia is currently under investigation. According to 2017 American Association for the Study of Liver Diseases (AASLD) and 2015 consensus guidelines from the Canadian Association for the Study of the Liver (CASL), ribavirin is typically used as an adjunct therapy to various first-line and second-line combination therapies recommended for each genotypes. Ribavirin is added to decrease relapse rates by accelerating viral clearance early in the treatment course [A19645]. When used to treat Hepatitis C virus (HCV) infections, it is always used as a part of combination therapies as ribavirin monotherapy is not efficacious in the treatment of chronic hepatitis C infection [A19644]. Additionally, including ribavirin in the regimen can increase the risk of anemia. In HCV genotye 1/2/3/4/5/6 patients, ribavirin can be used in combination therapy involving [DB09102] and [DB08934], Eplusa ([DB08934], [DB11613]), Harvoni ([DB08934], [DB09027]), [DB06290] and [DB08934], Viekira Pak ([DB09296], [DB09297], [DB00503], [DB09183]), Technivie ([DB00503], [DB09296], [DB09297]) and Zepatier ([DB11574], [DB11575]). Addition of weight-based ribavirin to Technivie therapy increased sustained virologic response after 12 weeks of daily therapy (SVR12) from 90% to 97% in patients with HCV genotype 1a and 90.9% to 100% in HCV genotype 4 patients [L852]. Zepatier therapy along with ribavirin improved SVR in HCV genotype 5 patients. Combination therapy of ribavirin and [DB00008] results in the SVR of 44% in patients with genotype 1 infection and 70% in patients with genotype 2-6. The inclusion of ribavirin in the combination therapies depend on individual patient's profile, for example if HCV genotype 3 patient has a Y93H genetic variant and compensated cirrhosis.
Indications and Usage Indicated for the treatment of chronic Hepatitis C virus (HCV) infection in combination with other antiviral agents with the intent to cure or achieve a sustained virologic response (SVR). Typically added to improve SVR and reduce relapse rates [A19644]. The addition of ribavirin in Technivie therapy indicated for treating HCV genotype 1a and 4 infections is recommended in patients with or without cirrhosis. Resistance: viral genetic determinants resulting in variable response to ribavirin therapy has not been yet determined.
Marketing Status approved
ATC Code J05AP01
DrugBank ID DB00811
KEGG ID D00423
MeSH ID D012254
PubChem ID 37542
TTD Drug ID D0H3WI
NDC Product Code 65862-409; 66122-0002; 63629-2149; 68382-129; 68682-019; 49452-6221; 42494-423; 65841-632; 63552-122; 65862-207; 68475-003; 73301-006; 68382-128; 65841-603; 65862-290; 68382-395; 0187-0007; 65841-260; 68382-260; 14474-041; 51927-1671; 63552-120; 63552-121; 65841-129; 68382-127; 65841-046; 68382-046; 44657-0076; 63552-070
UNII 49717AWG6K
Synonyms Ribavirin | Ribovirin | Tribavirin | Rebetol | Virazole | Vilona | Ribasphere | Viramide | Virazide | ICN-1229 | ICN 1229 | ICN1229 | Ribamide | Ribamidil | Ribamidyl
Chemical Information
Molecular Formula C8H12N4O5
CAS Registry Number 36791-04-5
SMILES C1=NC(=NN1C2C(C(C(O2)CO)O)O)C(=O)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.101665%
Abdominal pain07.01.05.0020.335851%
Abdominal pain upper07.01.05.0030.217175%
Abdominal tenderness07.01.05.0040.003956%Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal faeces07.01.03.0010.013450%Not Available
Abortion18.01.01.0010.003956%Not Available
Acidosis14.01.03.0020.005934%
Acute hepatic failure09.01.03.0010.027691%Not Available
Acute leukaemia16.01.02.001; 01.10.02.0010.003956%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.035603%Not Available
Acute psychosis19.03.01.0010.013845%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.003956%Not Available
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.015823%
Adrenal suppression14.11.01.005; 05.01.02.0020.005934%Not Available
Affective disorder19.04.04.0010.012659%Not Available
Ageusia17.02.07.001; 07.14.03.0030.025713%Not Available
Aggression19.05.01.0010.077930%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.039558%Not Available
Alcohol problem19.07.06.003--Not Available
Alcoholism19.07.06.0060.007912%Not Available
Alopecia23.02.02.0010.355630%
Alopecia totalis23.02.02.0060.003956%Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.0013.999351%
Anal fissure07.03.01.0020.020570%
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ADReCS-Target
Drug Name ADR Term Target
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