Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ritonavir
Drug ID BADD_D01952
Description Ritonavir is an HIV protease inhibitor that interferes with the reproductive cycle of HIV. Although it was initially developed as an independent antiviral agent, it has been shown to possess advantageous properties in combination regimens with low-dose ritonavir and other protease inhibitors. It is now more commonly used as a booster of other protease inhibitors and is available in both liquid formulation and as capsules. While ritonavir is not an active antiviral agent against hepatitis C virus (HCV) infection, it is added in combination therapies indicated for treatment of HCV infections as a booster. Ritonavir is a potent CYP3A inhibitor that increases peak and trough plasma drug concentrations of other protease inhibitors such as [DB09297] and overall drug exposure. American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) guidelines recommend ritonavir-boosted combination therapies as a first-line therapy for HCV Genotype 1a/b and 4 treatment-na?ve patients with or without cirrhosis. Ritonavir is found in a fixed-dose combination product with [DB09296], [DB09183], and [DB09297] as the FDA-approved product Viekira Pak. First approved in December 2014, Viekira Pak is indicated for the treatment of HCV genotype 1b without cirrhosis or with compensated cirrhosis, and when combined with Ribavirin for the treatment of HCV genotype 1a without cirrhosis or with compensated cirrhosis. Ritonavir is also available as a fixed-dose combination product with [DB09296] and [DB09297] as the FDA- and Health Canada-approved product Technivie. First approved in July 2015, Technivie is indicated in combination with Ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. In Canada, ritonavir is also available as a fixed-dose combination product with [DB09296], [DB09183], and [DB09297] as the Health Canada-approved, commercially available product Holkira Pak. First approved in January 2015, Holkira Pak is indicated for the treatment of HCV genotype 1b with or without cirrhosis, and when combined with Ribavirin for the treatment of HCV genotype 1a with or without cirrhosis. Inclusion of ritonavir can can select for HIV-1 protease inhibitor resistance-associated substitutions. Any HCV/HIV-1 co-infected patients treated with ritonavir-containing combination therapies should also be on a suppressive antiretroviral drug regimen to reduce the risk of HIV-1 protease inhibitor drug resistance.
Indications and Usage Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Marketing Status Prescription; Discontinued
ATC Code J05AE03
DrugBank ID DB00503
KEGG ID D00427
MeSH ID D019438
PubChem ID 392622
TTD Drug ID D0ZU9R
NDC Product Code 0074-3399; 65862-687; 53104-7708; 0074-3333; 0054-0407; 52562-018; 60687-420; 65862-410; 0074-1940; 65977-0066; 31722-597; 53808-1119; 68554-0117; 47621-035; 55111-896; 12613-3333; 65162-061
Synonyms Ritonavir | ABT 538 | ABT-538 | ABT538 | Norvir
Chemical Information
Molecular Formula C37H48N6O5S2
CAS Registry Number 155213-67-5
SMILES CC(C)C1=NC(=CS1)CN(C)C(=O)NC(C(C)C)C(=O)NC(CC2=CC=CC=C2)CC(C(CC3=CC=CC=C3)NC(=O) OCC4=CN=CS4)O
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.006734%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.006734%
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal faeces07.01.03.001--Not Available
Abortion spontaneous18.01.04.0010.003367%Not Available
Acne23.02.01.001--Not Available
Acute leukaemia01.10.02.001; 16.01.02.001--Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.001--Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.0040.008417%
Adrenal suppression05.01.02.002; 14.11.01.0050.005050%Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.01.0030.003367%
Albuminuria20.02.01.001--Not Available
Alcohol intolerance14.02.01.001--
Alveolitis allergic10.01.03.008; 22.01.01.0020.003367%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea05.05.01.002; 21.01.02.0010.005050%
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.0010.008417%
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anorectal disorder07.03.01.001--Not Available
Anxiety19.06.02.002--
Aphasia17.02.03.001; 19.21.01.001--
Appendicitis07.19.01.001; 11.01.07.0010.005050%
Arthralgia15.01.02.001--
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ADReCS-Target
Drug Name ADR Term Target
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