Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Peginterferon alfa-2b
Drug ID BADD_D01696
Description Peginterferon alfa-2b is a form of recombinant interferon used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). 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]. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) resulting in less use of Peginterferon alfa-2b. Peginterferon alfa-2b is derived from the alfa-2b moeity of recombinant human interferon and acts by binding to human type 1 interferon receptors. Activation and dimerization of this receptor induces the body's innate antiviral response by activating the janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway. Use of Peginterferon alfa-2b is associated with a wide range of severe adverse effects including the aggravation and development of endocrine and autoimmune disorders, retinopathies, cardiovascular and neuropsychiatric complications, and increased risk of hepatic decompensation in patients with cirrhosis. The use of Peginterferon alfa-2b has largely declined since newer interferon-free antiviral therapies have been developed. In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) no longer recommend Peginterferon alfa-2b for the treatment of Hepatitis C [A19593]. Peginterferon alfa-2b was used alongside [DB00811] with the intent to cure, or achieve a sustained virologic response (SVR), after 48 weeks of therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality [A19626]. Peginterferon alfa-2b is available as a variable dose injectable product (tradename Pegintron) used for the treatment of chronic Hepatitis C. Approved in 2001 by the FDA, Pegintron is indicated for the treatment of HCV with [Ribavirin] or other antiviral drugs [FDA Label]. When combined together, Peginterferon alfa-2b and [Ribavirin] have been shown to achieve a SVR between 41% for genotype 1 and 75% for genotypes 2-6 after 48 weeks of treatment.
Indications and Usage Not Available
Marketing Status Prescription
ATC Code L03AB10
DrugBank ID DB00022
KEGG ID D02748
MeSH ID C417083
PubChem ID Not Available
TTD Drug ID D08NWC
NDC Product Code 53713-0085; 53713-0083; 53713-0084; 53713-0075
Synonyms peginterferon alfa-2b | PEG-IFNalpha-2b | PEG INF alfa-2b | PEG INF alpha-2b | polyethylene glycol-interferon alfa-2b | pegylated interferon alfa-2b | peg-proline-interferon alpha-2b | peg-proline-INFalpha-2b | Pegintron | ViraferonPeg | PEG-Intron
Chemical Information
Molecular Formula Not Available
CAS Registry Number 215647-85-1
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
AstheniaAcute lymphocytic leukemia (ALL) BCR-ABL mRNA encoding P185-ALL-ABL proteinQ13745Not AvailableNot Available
Gastrointestinal disordersOxytocin receptorP30559T84486Not Available
Neuropathy peripheralAcute lymphocytic leukemia (ALL) BCR-ABL mRNA encoding P185-ALL-ABL proteinQ13745Not AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anger19.04.02.001--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002--Not Available
Aplasia pure red cell10.02.01.003; 01.03.03.001--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Blood thyroid stimulating hormone abnormal13.10.03.005--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.001--
Deafness04.02.01.001--Not Available
Dehydration14.05.05.001--
Depression19.15.01.001--
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.001--Not Available
Diarrhoea07.02.01.001--
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
The 1th Page    1 2 3 4    Next   Last    Total 4 Pages